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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06430801




Registration number
NCT06430801
Ethics application status
Date submitted
21/05/2024
Date registered
28/05/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
MK-7240-008
Secondary ID [2] 0 0
7240-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IV Tulisokibart
Treatment: Drugs - SC Tulisokibart
Other interventions - IV Placebo
Other interventions - 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 continue 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 continue 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 continue 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 continue 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: SC Tulisokibart
Humanized monoclonal antibody that binds human TL1A, administered subcutaneously

Other interventions: IV Placebo
Placebo matching IV tulisokibart

Other interventions: SC Placebo
Placebo matching SC tulisokibart
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
Timepoint [3] 0 0
Week 52
Primary outcome [4] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Timepoint [4] 0 0
Week 12
Primary outcome [5] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Timepoint [5] 0 0
Week 12
Primary outcome [6] 0 0
Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Timepoint [6] 0 0
Week 12
Primary outcome [7] 0 0
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Timepoint [7] 0 0
Week 12
Primary outcome [8] 0 0
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Timepoint [8] 0 0
Week 12
Primary outcome [9] 0 0
Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [1] 0 0
Study 1: Percentage of Participants Who Experienced an Adverse Event (AE)
Timepoint [1] 0 0
Up to approximately 52 weeks
Secondary outcome [2] 0 0
Study 1: Percentage of Participants who Discontinue Study Intervention due to an AE
Timepoint [2] 0 0
Up to approximately 52 weeks
Secondary outcome [3] 0 0
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Study 1: Percentage of Participants with Decrease of =100 Points in CDAI Score from Baseline to Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Study 1: Percentage of Participants with Decrease of =100 Points in CDAI Score from Baseline to Week 52
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52
Timepoint [14] 0 0
Week 12 and Week 52
Secondary outcome [15] 0 0
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52
Timepoint [19] 0 0
Baseline and Week 52
Secondary outcome [20] 0 0
Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52
Timepoint [20] 0 0
Baseline and Week 52
Secondary outcome [21] 0 0
Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52
Timepoint [21] 0 0
Week 52
Secondary outcome [22] 0 0
Study 2: Percentage of Participants Who Experienced an AE
Timepoint [22] 0 0
Up to approximately 12 weeks
Secondary outcome [23] 0 0
Study 2: Percentage of Participants who Discontinue Study Intervention due to an AE
Timepoint [23] 0 0
Up to approximately 12 weeks
Secondary outcome [24] 0 0
Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
Timepoint [24] 0 0
Week 12
Secondary outcome [25] 0 0
Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
Timepoint [25] 0 0
Week 12
Secondary outcome [26] 0 0
Study 2: Percentage of Participants with Decrease of =100 Points in CDAI Score from Baseline to Week 12
Timepoint [26] 0 0
Week 12
Secondary outcome [27] 0 0
Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12
Timepoint [27] 0 0
Baseline and Week 12
Secondary outcome [28] 0 0
Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12
Timepoint [28] 0 0
Week 12
Secondary outcome [29] 0 0
Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
Timepoint [29] 0 0
Baseline and Week 12
Secondary outcome [30] 0 0
Study 2: Percentage of Participants with Decrease of =100 Points in CDAI Score from Baseline to Week 6
Timepoint [30] 0 0
Week 6
Secondary outcome [31] 0 0
Study 2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12
Timepoint [31] 0 0
Week 12

Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:



* Has had a diagnosis of CD at least 3 months before study.
* Has moderately to severely active CD.
* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
* Adolescent participants =16 and <18 years of age can participate if approved by the country or regulatory/health authority.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
* Has current stoma or need for colostomy or ileostomy.
* Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
* Has surgical bowel resection within 3 months of study.
* Has prior or current gastrointestinal dysplasia.
* Has chronic infection requiring ongoing antimicrobial treatment.
* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
* Has active tuberculosis.
* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-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
5/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/11/2029
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202) - Concord
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital ( Site 3200) - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hosp - GI Clinical Trials ( Site 3203) - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital-Gastroenterology ( Site 3201) - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Connecticut
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District of Columbia
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Georgia
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Kyoto
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Okayama
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Walsall

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT06430801