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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Other: SC Placebo; Drug: IV Tulisokibart; Other: IV Placebo; Drug: SC Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06430801

7240-008

2023-508636-61 (Registry Identifier)

U1111-1298-6080 (Other Identifier)

MK-7240-008 (Other Identifier)

jRCT2031240196 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 11 patient groups, including a placebo group

Study 1: High Dose Induction, High Dose Maintenance

Experimental group

Description:

Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.

Treatment:

Drug: SC Tulisokibart

Drug: IV Tulisokibart

Study 1: High Dose Induction, Low Dose Maintenance

Experimental group

Description:

Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Treatment:

Drug: SC Tulisokibart

Drug: IV Tulisokibart

Other: SC Placebo

Study 1: Low Dose Induction, Low Dose Maintenance

Experimental group

Description:

Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.

Treatment:

Drug: SC Tulisokibart

Drug: IV Tulisokibart

Other: SC Placebo

Study 1: Placebo

Placebo Comparator group

Description:

Participants receive IV placebo, followed by an SC placebo regimen.

Treatment:

Other: IV Placebo

Drug: IV Tulisokibart

Other: SC Placebo

Study 1: High Dose Extension

Experimental group

Description:

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.

Treatment:

Drug: SC Tulisokibart

Study 1: Low Dose Extension

Experimental group

Description:

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.

Treatment:

Drug: SC Tulisokibart

Other: SC Placebo

Study 2: High Dose Induction

Experimental group

Description:

Participants receive high dose IV tulisokibart.

Treatment:

Drug: IV Tulisokibart

Study 2: Low Dose Induction

Experimental group

Description:

Participants receive low dose IV tulisokibart.

Treatment:

Drug: IV Tulisokibart

Other: SC Placebo

Study 2: Placebo

Placebo Comparator group

Description:

Participants receive IV placebo.

Treatment:

Other: IV Placebo

Drug: IV Tulisokibart

Other: SC Placebo

Study 2: High Dose Extension

Experimental group

Description:

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.

Treatment:

Drug: SC Tulisokibart

Study 2: Low Dose Extension

Experimental group

Description:

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.

Treatment:

Drug: SC Tulisokibart