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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 16 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

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) within the last 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-anti-TL1A antibody.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
Experimental
Study 1: High Dose Induction, Low Dose Maintenance 		Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Experimental
Study 1: Low Dose Induction, Low Dose Maintenance 		Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Placebo Comparator
Study 1: Placebo 		Participants receive IV placebo, followed by an SC placebo regimen.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Other: IV Placebo
    Placebo matching IV tulisokibart
  • Other: SC Placebo
    Placebo matching SC tulisokibart
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.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
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.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Experimental
Study 2: High Dose Induction 		Participants receive high dose IV tulisokibart.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
Experimental
Study 2: Low Dose Induction 		Participants receive low dose IV tulisokibart.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Other: SC Placebo
    Placebo matching SC tulisokibart
Placebo Comparator
Study 2: Placebo 		Participants receive IV placebo.
  • Drug: IV Tulisokibart
    Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
    Other names:
    • PRA023
    • MK-7240
  • Other: IV Placebo
    Placebo matching IV tulisokibart
  • Other: SC Placebo
    Placebo matching SC tulisokibart
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.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240
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.
  • Drug: SC Tulisokibart
    Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
    Other names:
    • PRA023
    • MK-7240

Recruiting Locations

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
Nashville, Tennessee 37204
Contact:
Study Coordinator
615-322-2312

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For general questions about clinical trials, contact Research Support Services at (615) 322-7343 or research.support.services@vumc.org