A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005) (ARTEMIS-UC)

Prometheus Biosciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Tulisokibart; Device: Companion Diagnostic (CDx) Testing; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04996797

PRA023 (Other Identifier)

PR200-102

2021-000091-11 (EudraCT Number)

MK-7240-005 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Confirmed diagnosis of ulcerative colitis (UC)
• Has moderately to severely active UC as defined by 3-component Modified Mayo score
• Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.

Exclusion criteria

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

• Has diagnosis of Crohn's disease or indeterminate colitis
• Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
• Has current or impending need for colostomy or ileostomy
• Has had surgical bowel resection within 3 months before screening
• Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 4 patient groups, including a placebo group

Cohort 1 Tulisokibart

Experimental group

Description:

Participants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Treatment:

Drug: Tulisokibart

Cohort 1 Placebo

Placebo Comparator group

Description:

Participants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Treatment:

Other: Placebo

Cohort 2 Tulisokibart

Experimental group

Description:

Participants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Treatment:

Device: Companion Diagnostic (CDx) Testing

Drug: Tulisokibart

Cohort 2 Placebo

Placebo Comparator group

Description:

Participants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Treatment:

Other: Placebo

Device: Companion Diagnostic (CDx) Testing