A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

NCT06430801
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,200
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2024-06-05
clinicaltrials.gov
Number of sites
499
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Summary
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. 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 Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). 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 Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
clinicaltrials.gov
Short 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)
clinicaltrials.gov
Official 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
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Control arm
Placebo
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Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
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Study type
Interventional
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Completion date
2029-11-12
clinicaltrials.gov
First posted
2024-05-28
clinicaltrials.gov
Registry last updated
2026-08-21
clinicaltrials.gov
Primary completion date
2028-10-30
clinicaltrials.gov
Start date
2024-06-05
clinicaltrials.gov

Participants
1,200
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
1,200
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Protocol amendments
3
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Number of sites
499
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06430801
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06430801
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  2. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical remission per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

  3. Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52

    Timeframe: Week 52

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in Simplified endoscopic score for Crohn's disease (SES-CD) from baseline for Study 1 will be presented.

  4. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  5. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

  6. Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12

    Timeframe: Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 1 will be presented.

  7. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 2 will be presented.

  8. Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

  9. Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

    Timeframe: Week 12

    The percentage of participants achieving endoscopic response, as defined by a ≥50% decrease in SES-CD from baseline for Study 2 will be presented.

  1. Study 1: Number of Participants Who Experienced an Adverse Event (AE)

    Timeframe: Up to approximately 52 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 1 will be presented.

  2. Study 1: Number of Participants Who Discontinue Study Intervention due to an AE

    Timeframe: Up to approximately 52 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 1 will be presented.

  3. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

  4. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  5. Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decrease From Baseline of ≥100 Points) at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.

  6. Study 1: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

    Timeframe: Baseline and Week 12

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater fatigue. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.

  7. Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12

    Timeframe: Week 12

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

  8. Study 1 and 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI Score at Week 12

    Timeframe: Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 and Study 2 will be presented.

  9. Study 1 and 2: Percentage of Participants in Dx+ Subpopulation Achieving Endoscopic Response at Week 12

    Timeframe: Week 12

    Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The percentage of Dx+ participants achieving endoscopic response, as defined by a ≥50% decrease in simplified endoscopic score for Crohn's disease (CD) from baseline for Study 1 and Study 2 will be presented.

  10. Study 1: Percentage of Participants With Clinical Response (Decrease From Baseline at Least 100 Points) or Clinical Remission (<150) per CDAI Score at Week 6

    Timeframe: Week 6

    The percentage of participants achieving clinical response (defined as decrease from baseline of ≥100 points in CDAI) or clinical remission (defined as CDAI \<150) for Study 1 will be presented.

  11. Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 1 will be presented.

  12. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  13. Study 1: Percentage of Participants With Clinical Response per CDAI Score (Decreased From Baseline of ≥100 Points) at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical response, defined as decrease from baseline of ≥100 points in CDAI for Study 1 will be presented.

  14. Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52

    Timeframe: Week 52

    The percentage of participants achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented. SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing), each on a scale from 0 to 3, in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, left colon/sigmoid, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

  15. Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52

    Timeframe: Week 12 and Week 52

    The percentage of participants achieving sustained clinical remission, as defined by CDAI score \<150 for Study 1 will be presented.

  16. Study 1 [US/FDA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52

    Timeframe: Week 52

    The percentage of participants who are in clinical remission as defined by CDAI score \<150 and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.

  17. Study 1 [EU/EMA Only]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52

    Timeframe: Week 52

    The percentage of participants who are in clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline and without corticosteroid use for CD at least 90 days prior to that assessment for Study 1 will be presented.

  18. Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented.

  19. Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score and Endoscopic Remission at Week 52

    Timeframe: Week 52

    The percentage of participants achieving clinical remission as defined by CDAI score \<150, and achieving endoscopic remission, as defined by SES-CD ≤4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable for Study 1 will be presented.

  20. Study 1: Mean Change From Baseline in FACIT-Fatigue Score at Week 52

    Timeframe: Baseline and Week 52

    The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0 to 52-point scale, with lower scores indicating greater. The mean change from baseline in FACIT-Fatigue score for Study 1 will be presented.

  21. Study 1 [EU/EMA Only]: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52

    Timeframe: Baseline and Week 52

    The IBDQ measures health related quality of life in participants with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges between 32 to 224, with higher scores indicating a better quality of life. The mean change from baseline in IBDQ score for Study 1 will be presented.

  22. Study 1: Percentage of Participants With Ulcer-Free Endoscopy at Week 52

    Timeframe: Week 52

    The percentage of participants achieving ulcer-free endoscopy (mucosal healing), as defined by SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥1 at baseline for Study 1 will be presented.

  23. Study 2: Number of Participants Who Experienced an AE

    Timeframe: Up to approximately 12 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE for Study 2 will be presented.

  24. Study 2: Number of Participants Who Discontinue Study Intervention due to an AE

    Timeframe: Up to approximately 12 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE for Study 2 will be presented.

  25. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12

    Timeframe: Week 12

    The percentage of participants achieving clinical remission per SF/APS, as defined by average daily SF ≤2.8 and average daily APS ≤1.0 and both not greater than baseline for Study 2 will be presented.

And 7 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
16 Years
Maximum age
80 Years
Healthy volunteers
No

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

  • Has had a diagnosis of Crohn's disease (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.

  • 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 CD.
  • 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-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
Sources for eligibility
clinicaltrials.gov

  • Digestive Health Specialists ( Site 5064)Dothan, United StatesCompleted
  • Arizona Arthritis & Rheumatology Research, PC ( Site 5094)Phoenix, United StatesCompleted
  • GI Alliance - Sun City ( Site 5118)Sun City, United StatesRecruiting
  • University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)Tucson, United StatesRecruiting
  • University of Arkansas for Medical Sciences ( Site 5147)Little Rock, United StatesRecruiting
  • Clinnova Research ( Site 5110)Anaheim, United StatesRecruiting
  • Southern California Research Center ( Site 5044)Coronado, United StatesRecruiting
  • Om Research LLC ( Site 5038)Lancaster, United StatesRecruiting
  • Cedars Sinai Medical Center ( Site 5080)Los Angeles, United StatesRecruiting
  • UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)Los Angeles, United StatesRecruiting
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)Orange, United StatesRecruiting
  • Om Research LLC ( Site 5045)Oxnard, United StatesRecruiting
  • Clinical Applications Laboratories ( Site 5123)San Diego, United StatesRecruiting
  • Amicis Research Center ( Site 5055)Valencia, United StatesActive, not recruiting
  • University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)Aurora, United StatesRecruiting
  • Peak Gastroenterology Associates ( Site 5023)Colorado Springs, United StatesRecruiting
  • South Denver Gastroenterology, PC ( Site 5132)Englewood, United StatesRecruiting
  • Rocky Mountain Gastroenterology ( Site 5082)Lakewood, United StatesRecruiting
  • Medical Research Center of Connecticut ( Site 5005)Hamden, United StatesCompleted
  • Yale University School of Medicine-Digestive Disease ( Site 5019)New Haven, United StatesRecruiting
  • Emerson Clinical Research Institute ( Site 5051)Washington D.C., United StatesRecruiting
  • Gastroenterology Consultants of Clearwater ( Site 5052)Clearwater, United StatesActive, not recruiting
  • Covenant Metabolic Specialists, LLC ( Site 5150)Fort Myers, United StatesRecruiting
  • Nature Coast Clinical Research - Inverness ( Site 5042)Inverness, United StatesRecruiting
  • Atlantic Medical Research ( Site 5073)Margate, United StatesActive, not recruiting

And 474 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-7240-008
  • 2023
  • U1111-1298-6080
  • jRCT2031240196
  • 2023-508636-61-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)