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

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• IV Tulisokibart — DRUG
  Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
• SC Tulisokibart — DRUG
  Humanized monoclonal antibody that binds human TL1A, administered subcutaneously
• IV Placebo — OTHER
  Placebo matching IV tulisokibart
• SC Placebo — OTHER
  Placebo matching SC tulisokibart

Study Details

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).

Key Dates

Start date

Jun 5, 2024

Status verified

Jun 2026

Primary completion

Oct 30, 2028

Completion

Nov 12, 2029

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

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

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (87)

Find similar trials in Dothan, AL

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