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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06052059




Registration number
NCT06052059
Ethics application status
Date submitted
18/09/2023
Date registered
25/09/2023
Date last updated
22/08/2024

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Induction and Maintenance Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
PR200-301
Secondary ID [2] 0 0
7240-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IV Tulisokibart
Treatment: Drugs - IV Placebo
Treatment: Drugs - SC Tulisokibart
Treatment: Drugs - SC Placebo

Experimental: Study 1: High Dose Induction, High Dose Maintenance - Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.

Experimental: Study 1: High Dose Induction, Low Dose Maintenance - Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Experimental: Study 1: Low Dose Induction, Low Dose Maintenance - Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Placebo comparator: Study 1: Placebo - Participants receive IV placebo, followed by an SC placebo regimen.

Experimental: Study 1: High Dose Extension - Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Experimental: Study 1: Low Dose Extension - Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.

Experimental: Study 2: High Dose Induction - Participants receive high dose IV tulisokibart.

Experimental: Study 2: Low Dose Induction - Participants receive low dose IV tulisokibart.

Placebo comparator: Study 2: Placebo - Participants receive IV placebo.

Experimental: Study 2: High Dose Extension - Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Experimental: Study 2: Low Dose Extension - Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.


Treatment: Drugs: IV Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously

Treatment: Drugs: IV Placebo
Placebo matching IV tulisokibart

Treatment: Drugs: SC Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously

Treatment: Drugs: SC Placebo
Placebo matching SC tulisokibart
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Study 1: Percentage of Participants With One or More Adverse Events (AEs)
Timepoint [3] 0 0
Up to approximately 52 weeks
Primary outcome [4] 0 0
Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE
Timepoint [4] 0 0
Up to approximately 52 weeks
Primary outcome [5] 0 0
Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12
Timepoint [5] 0 0
Week 12
Primary outcome [6] 0 0
Study 2: Percentage of Participants With One or More AEs
Timepoint [6] 0 0
Up to approximately 12 weeks
Primary outcome [7] 0 0
Study 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE
Timepoint [7] 0 0
Up to approximately 12 weeks
Secondary outcome [1] 0 0
Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2
Timepoint [1] 0 0
Week 2
Secondary outcome [2] 0 0
Study 1: Percentage of Participants With Endoscopic Improvement at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Study 1: Percentage of Participants With Endoscopic Remission at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
Timepoint [10] 0 0
Baseline and Week 12
Secondary outcome [11] 0 0
Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Percentage of Dx+ Participants With Endoscopic Improvement at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
Study 1: Percentage of Participants with Endoscopic Improvement at Week 52
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Study 1: Percentage of Participants Achieving HEMI at Week 52
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52
Timepoint [18] 0 0
Week 12 and Week 52
Secondary outcome [19] 0 0
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52
Timepoint [19] 0 0
Week 52
Secondary outcome [20] 0 0
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52
Timepoint [20] 0 0
Week 52
Secondary outcome [21] 0 0
Study 1: Percentage of Participants With Endoscopic Remission at Week 52
Timepoint [21] 0 0
Week 52
Secondary outcome [22] 0 0
Study 1: Percentage of Participants with Sustained Clinical Response Per MMS at Both Week 12 and Week 52
Timepoint [22] 0 0
Week 12, and Week 52
Secondary outcome [23] 0 0
Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52
Timepoint [23] 0 0
Week 12 and Week 52
Secondary outcome [24] 0 0
Study 1: Percentage of Participants Achieving HER at Week 52
Timepoint [24] 0 0
Week 52
Secondary outcome [25] 0 0
Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52
Timepoint [25] 0 0
Week 52
Secondary outcome [26] 0 0
Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52
Timepoint [26] 0 0
Baseline and Week 52
Secondary outcome [27] 0 0
Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52
Timepoint [27] 0 0
Week 52
Secondary outcome [28] 0 0
Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52
Timepoint [28] 0 0
Week 52
Secondary outcome [29] 0 0
Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2
Timepoint [29] 0 0
Week 2
Secondary outcome [30] 0 0
Study 2: Percentage of Participants With Endoscopic Improvement at Week 12
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12
Timepoint [31] 0 0
Week 12
Secondary outcome [32] 0 0
Study 2: Percentage of Participants Achieving HEMI at Week 12
Timepoint [32] 0 0
Week 12
Secondary outcome [33] 0 0
Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12
Timepoint [33] 0 0
Week 12
Secondary outcome [34] 0 0
Study 2: Percentage of Participants With Endoscopic Remission at Week 12
Timepoint [34] 0 0
Week 12
Secondary outcome [35] 0 0
Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12
Timepoint [35] 0 0
Week 12
Secondary outcome [36] 0 0
Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12
Timepoint [36] 0 0
Week 12
Secondary outcome [37] 0 0
Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12
Timepoint [37] 0 0
Week 12
Secondary outcome [38] 0 0
Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12
Timepoint [38] 0 0
Baseline and Week 12
Secondary outcome [39] 0 0
Study 2: Percentage of Participants Achieving HER at Week 12
Timepoint [39] 0 0
Week 12

Eligibility
Key inclusion criteria
* Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization
* Has moderately to severely active UC
* Weight =40 kg
* Satisfies at least 1 of the following criteria:

* Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
* Protocol specified corticosteroid dependence
* Has been intolerant to 1 or more protocol-specified UC treatments
* Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
* Adolescent participants =16 and <18 years of age can participate if approved by the country or regulatory/health authority
* Participant assigned male sex at birth, if capable of producing sperm, agrees to abstain from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent; or uses prescribed contraception unless azoospermic
* A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
* Has a current diagnosis of fulminant colitis and/or toxic megacolon
* Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
* Has a current or impending need for colostomy or ileostomy
* Has had a total proctocolectomy or partial colectomy
* Has received fecal microbial transplantation within 4 weeks before randomization
* Has been hospitalized for the treatment of UC within 2 weeks before screening
* Has prior or current evidence of definite low-grade or high-grade colonic dysplasia including dysplasia identified during the Screening colonoscopy that has not been completely removed
* Has any active or serious infections without resolution after adequate treatment
* Has had a herpes zoster reactivation or cytomegalovirus that resolved less than 8 weeks before screening
* Has a transplanted organ which requires continued immunosuppression
* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
* Has confirmed or suspected COVID-19 infection
* Has a history of drug or alcohol abuse within 6 months prior to screening
* Has had major surgery within 3 months before screening or has a major surgery (i.e, requiring general anesthesia) planned during the study
* Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
* Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
* Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
* Has received protocol-specified prohibited medications
* Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2029
Actual
Sample size
Target
1020
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Misericordiae Limited-Gastroenterology ( Site 2506) - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Iowa
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Louisiana
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Michigan
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New York
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North Carolina
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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Utah
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Tucuman
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Canada
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Ontario
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Chile
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Los Rios
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Chile
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Region M. De Santiago
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Beijing
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Chongqing
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Guangdong
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Hebei
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China
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Henan
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China
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Hubei
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China
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Hunan
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Jiangsu
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Shandong
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Shanghai
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Xinjiang
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China
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Yunnan
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Zhejiang
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Croatia
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Grad Zagreb
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Dominican Republic
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Distrito Nacional
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Greece
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Attiki
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Greece
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Kentriki Makedonia
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Greece
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Kriti
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Kfar Saba
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Petah Tikva
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Ramat Gan
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Foggia
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Roma
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Italy
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Sicilia
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Italy
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Verona
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Italy
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Milano
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Italy
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Pavia
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Japan
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Aichi
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Chiba
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Fukuoka
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Hiroshima
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Hokkaido
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Mie
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Osaka
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Shizuoka
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Tokyo
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Yamanashi
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Fukui
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Kyoto
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Oita
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Saga
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Toyama
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Korea, Republic of
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Kang-won-do
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Seoul
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Korea, Republic of
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Taegu-Kwangyokshi
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Korea, Republic of
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Taejon-Kwangyokshi
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Netherlands
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Gelderland
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Utrecht
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Poland
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Dolnoslaskie
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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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Viana do Castelo
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Switzerland
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Berne
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Switzerland
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Sankt Gallen
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Switzerland
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Zurich
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Taiwan
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Changhua
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Taiwan
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Hsinchu
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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United Kingdom
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England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD, Part of Thermo Fisher Scientific
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
Trial website
https://clinicaltrials.gov/study/NCT06052059
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06052059