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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06819878
Registration number
NCT06819878
Ethics application status
Date submitted
6/02/2025
Date registered
11/02/2025
Date last updated
15/07/2025
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
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Scientific title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
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Secondary ID [1]
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2024-513053-69-00
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Secondary ID [2]
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GA45331
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Universal Trial Number (UTN)
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Trial acronym
SIBERITE-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Moderately to Severely Active Crohns Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Afimkibart
Treatment: Drugs - Placebo
Experimental: Arm 1: Afimkibart - Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Experimental: Arm 2: Afimkibart - Participants will receive afimkibart IV followed by afimkibart SC injection.
Placebo comparator: Arm 3: Placebo - Participants will receive placebo IV followed by placebo SC.
Treatment: Drugs: Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Treatment: Drugs: Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
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Assessment method [1]
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Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
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Timepoint [1]
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At Week 52
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Primary outcome [2]
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Percentage of Participants with Endoscopic Response
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Assessment method [2]
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Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
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Timepoint [2]
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At Week 52
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Secondary outcome [1]
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Percentage of Participants with Clinical Remission
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Assessment method [1]
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Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
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Timepoint [1]
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At Week 12
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Secondary outcome [2]
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Percentage of Participants with Endoscopic Response
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Assessment method [2]
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Percentage of participants achieving a decrease in SES-CD of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
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Timepoint [2]
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At Week 12
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Secondary outcome [3]
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Percentage of Participants with Symptomatic Remission
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Assessment method [3]
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Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
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Timepoint [3]
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At Week 12
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Secondary outcome [4]
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Percentage of Participants with Endoscopic Remission
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Assessment method [4]
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Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1.
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Timepoint [4]
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At Week 12
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Secondary outcome [5]
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Percentage of Participants with Ulcer-free Endoscopy
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Assessment method [5]
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Percentage of participants with an SES-CD ulcerated surface subscore of 0.
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Timepoint [5]
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At Week 12
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Secondary outcome [6]
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Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
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Assessment method [6]
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Daily average number of liquid or very soft stools over 7 days.
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Timepoint [6]
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Baseline through Week 12
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Secondary outcome [7]
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Average of Daily Abdominal Pain Scores in the Past Week (APS)
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Assessment method [7]
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The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
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Timepoint [7]
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Baseline through Week 12
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Secondary outcome [8]
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Percentage of Participants with Endoscopic Remission
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Assessment method [8]
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Percentage of participants with SES-CD=0 to 4 with decrease from baseline \>=2 and no subscore \>1 .
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Timepoint [8]
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At Week 52
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Secondary outcome [9]
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Percentage of Participants with Symptomatic Remission
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Assessment method [9]
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Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
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Timepoint [9]
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At Week 52
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Secondary outcome [10]
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Percentage of Participants with Corticosteroid-free Clinical Remission
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Assessment method [10]
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Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
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Timepoint [10]
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At Week 52
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Secondary outcome [11]
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Maintenance of Clinical Remission
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Assessment method [11]
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Percentage of participants with clinical remission at both Weeks 12 and 52.
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Timepoint [11]
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At Weeks 12 and 52
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Secondary outcome [12]
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Maintenance of Endoscopic Response
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Assessment method [12]
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Percentage of participants with endoscopic response at both Weeks 12 and 52.
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Timepoint [12]
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At Weeks 12 and 52
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Secondary outcome [13]
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Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
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Assessment method [13]
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Percentage of participants achieving a CDAI score of \<150 and SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1 at Week 52.
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Timepoint [13]
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At Week 52
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Secondary outcome [14]
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Percentage of Participants with Ulcer-free Endoscopy
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Assessment method [14]
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Percentage of participants with an SES-CD ulcerated surface subscore of 0.
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Timepoint [14]
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At Week 52
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Secondary outcome [15]
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Bowel Urgency
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Assessment method [15]
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Bowel urgency from baseline through week 12 and week 52. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
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Timepoint [15]
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Baseline through Week 12 and Week 52
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Secondary outcome [16]
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Fatigue
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Assessment method [16]
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Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
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Timepoint [16]
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Baseline to Week 12 and Week 52
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Secondary outcome [17]
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Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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Assessment method [17]
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Change in IBDQ score from baseline to week 12 and 52. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
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Timepoint [17]
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Baseline to Week 12 and Week 52
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Secondary outcome [18]
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Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
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Assessment method [18]
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Percentage of participants achieving a CDAI score of \<150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
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Timepoint [18]
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At Week 12
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Secondary outcome [19]
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Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
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Assessment method [19]
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Percentage of participants achieving a CDAI score of \<150 at Week 52 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
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Timepoint [19]
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At Week 52
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Secondary outcome [20]
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Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
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Assessment method [20]
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Percentage of participants achieving a decrease in SES-CD of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
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Timepoint [20]
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0
At Week 12
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Secondary outcome [21]
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Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
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Assessment method [21]
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Percentage of participants achieving a decrease in SES-CD of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
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Timepoint [21]
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0
At Week 52
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Secondary outcome [22]
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Percentage of Participants with Clinical Response
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Assessment method [22]
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Percentage of participants with a decrease \>=100 in CDAI from baseline.
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Timepoint [22]
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At Week 12
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Secondary outcome [23]
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Percentage of Participants with Symptomatic Response
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Assessment method [23]
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Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
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Timepoint [23]
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At Week 12
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Secondary outcome [24]
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Overall Change in CD Symptoms
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Assessment method [24]
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Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
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Timepoint [24]
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Baseline to Weeks 2, 6, 12 and 52
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Secondary outcome [25]
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Overall Severity in CD Symptoms
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Assessment method [25]
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Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
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Timepoint [25]
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Baseline to Weeks 2, 6, 12 and 52
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Secondary outcome [26]
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Change in General Well-being
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Assessment method [26]
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The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
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Timepoint [26]
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Baseline through Week 52
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Secondary outcome [27]
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Incidence and Severity of Adverse Events (AEs)
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Assessment method [27]
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Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
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Timepoint [27]
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Up to 70 Weeks after Baseline
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Secondary outcome [28]
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Percentage of Participants with a Presence of Draining Fistulas
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Assessment method [28]
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Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
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Timepoint [28]
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Baseline through Week 12 and Week 52
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Eligibility
Key inclusion criteria
* Confirmed diagnosis of CD
* Moderately to severely active CD
* Bodyweight >= 40 kilogram (kg)
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
* Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
* Diagnosis of short gut or short bowel syndrome
* Presence of an ileostomy, colostomy or ileoanal pouch
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/03/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2033
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [2]
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Mater Misericordiae Limited - South Brisbane
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Alabama
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0
0
United States of America
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Arizona
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0
United States of America
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California
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0
United States of America
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Colorado
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0
United States of America
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Florida
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0
0
United States of America
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State/province [6]
0
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Georgia
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0
0
United States of America
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0
0
Idaho
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Indiana
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0
0
United States of America
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State/province [10]
0
0
Kansas
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Country [11]
0
0
United States of America
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State/province [11]
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0
Kentucky
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0
0
United States of America
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Massachusetts
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0
0
United States of America
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Michigan
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0
0
United States of America
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Mississippi
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0
0
United States of America
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Nevada
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0
0
United States of America
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New York
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0
0
United States of America
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State/province [17]
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0
North Carolina
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Country [18]
0
0
United States of America
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0
0
Ohio
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Oklahoma
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Pennsylvania
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Rhode Island
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0
0
United States of America
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State/province [22]
0
0
South Carolina
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Country [23]
0
0
United States of America
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0
0
Tennessee
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0
0
United States of America
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0
Texas
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Country [25]
0
0
United States of America
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0
0
Virginia
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0
0
United States of America
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State/province [26]
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0
Washington
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Country [27]
0
0
Argentina
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State/province [27]
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0
Ciudad Autonoma Bs As
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Country [28]
0
0
Austria
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State/province [28]
0
0
Wien
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Country [29]
0
0
Belgium
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State/province [29]
0
0
Aalst
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Country [30]
0
0
Belgium
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State/province [30]
0
0
Bruxelles
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Country [31]
0
0
Belgium
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State/province [31]
0
0
Edegem
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Country [32]
0
0
Belgium
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State/province [32]
0
0
Gent
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Country [33]
0
0
Belgium
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State/province [33]
0
0
Hasselt
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Country [34]
0
0
Belgium
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0
0
Liege
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Country [35]
0
0
Belgium
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State/province [35]
0
0
Liège
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0
0
Belgium
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State/province [36]
0
0
Mons
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0
0
Belgium
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0
0
Sint Niklaas
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0
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Canada
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0
Alberta
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0
0
Canada
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0
Quebec
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Chile
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State/province [40]
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0
Concepcion
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Country [41]
0
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Chile
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State/province [41]
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0
Santiago
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0
0
China
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0
0
Beijing
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Country [43]
0
0
China
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State/province [43]
0
0
Changchun
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0
0
China
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State/province [44]
0
0
Changsha
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0
0
China
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0
0
Chengdu City
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Country [46]
0
0
China
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State/province [46]
0
0
Chongqing City
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0
0
China
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State/province [47]
0
0
Fuzhou City
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Country [48]
0
0
China
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State/province [48]
0
0
Guangzhou City
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Country [49]
0
0
China
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State/province [49]
0
0
Hangzhou City
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Country [50]
0
0
China
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State/province [50]
0
0
Hefei
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Country [51]
0
0
China
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State/province [51]
0
0
Huizhou
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0
0
China
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State/province [52]
0
0
Nanchang City
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Country [53]
0
0
China
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Nanning
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China
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Ningbo City
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China
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Shanghai City
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China
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Shenzhen
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China
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Taizhou City
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China
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Wuhan City
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China
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Wuhan
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China
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Wuxi
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China
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Xiamen
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China
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Zhengzhou
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China
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Zhuzhou
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Denmark
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Herlev
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Dominican Republic
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Santo Domingo
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France
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Amiens
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France
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Marseille
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France
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Nice
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France
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Reims
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France
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Rennes
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France
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Saint Etienne
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Halle
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Germany
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Jena
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Germany
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Mannheim
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Germany
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Ulm
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Hungary
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Budapest
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Hungary
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Szekszard
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Israel
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Ramat Gan
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Italy
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Lazio
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Japan
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Chiba
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Utrecht
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Poland
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Bydgoszcz
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Poland
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Chojnice
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Poland
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Karczew
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Poland
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Pozna?
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Poland
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Toru?
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Poland
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Warszawa
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Wroc?aw
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Poland
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Zamosc
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Portugal
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Braga
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Portugal
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Lisboa
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Portugal
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Porto
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San Juan
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Spain
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Madrid
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Spain
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Murcia
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Taichung City
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Thailand
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Bangkok
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Thailand
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Songkhla
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United Kingdom
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State/province [106]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Chugai Pharmaceutical
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Address [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
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Trial website
https://clinicaltrials.gov/study/NCT06819878
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for public queries
Name
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0
Reference Study ID Number: GA45331 https://forpatients.roche.com/
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Address
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0
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0
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Phone
0
0
888-662-6728 (U.S. and Canada)
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06819878
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