Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Part of paid clinical trials in Bristol, Connecticut.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06651281
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Key Dates

Start date
Nov 25, 2024
Status verified
May 2026
Primary completion
Dec 17, 2037
Completion
Dec 17, 2037

Study Design

Enrollment
1,380 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Low Dose Unblinded
    Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
  • Experimental: Group 2: High Dose Unblinded
    Participants receive a high dose SC tulisokibart regimen.
  • Experimental: Group 3: High Dose Blinded
    Participants receive a blinded high dose SC tulisokibart regimen.
  • Experimental: Group 4: Low Dose Blinded
    Participants receive a blinded low dose SC tulisokibart regimen.

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 378 weeks ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Connecticut Clinical Research Institute ( Site 0297)BristolConnecticut06010
Study Coordinator
860-585-3000
St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)YpsilantiMichigan48197
Study Coordinator
734-418-7736
BVL Research - Kansas ( Site 0292)LibertyMissouri64068
Study Coordinator
785-217-6559
New York Gastroenterology Associates ( Site 0253)New YorkNew York10075
Study Coordinator
212-369-2490
GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)GarlandTexas75044
Study Coordinator
972-265-8201
Caprock Gastro Research ( Site 0293)LubbockTexas79424
Study Coordinator
808-239-1823
GI Alliance - Lubbock ( Site 0288)LubbockTexas79410
Study Coordinator
806-793-3141
Southern Star Research Institute ( Site 0299)San AntonioTexas78229
Study Coordinator
210-581-2812
GI Alliance - Southlake ( Site 0298)SouthlakeTexas76092-9167
Study Coordinator
817-424-1525
Tyler Research Institute ( Site 0294)TylerTexas75701
Study Coordinator
903-630-6211
University of Virginia Health System ( Site 0291)CharlottesvilleVirginia22908
Study Coordinator
434-243-3090
Washington Gastroenterology - Tacoma ( Site 0295)TacomaWashington98405
Study Coordinator
425-452-8547

Find similar trials in Bristol, CT

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Connecticut Clinical Research Institute· Bristol, CTSt. Joseph Mercy Hospital - Huron Gastroenterology Associates· Ypsilanti, MIBVL Research - Kansas· Liberty, MONew York Gastroenterology Associates· New York, NYGI Alliance - Digestive Health Associates of Texas - DHAT· Garland, TXCaprock Gastro Research· Lubbock, TX

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