A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006) (APOLLO-CD)

Prometheus Biosciences

Status and phase: Completed; Phase 2

Conditions: Crohn Disease

Treatments: Diagnostic Test: Companion Diagnostic (CDx); Biological: Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT05013905

7240-006 (Other Identifier)

2021-000092-37 (EudraCT Number)

PR200-103

U1111-1309-6108 (Registry Identifier)

2023-509742-35-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Crohn's disease (CD)
• Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
• 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 (TNF), anti-integrin, or anti-interleukin (IL)12/23
• Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion criteria

• Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
• Diagnosis of ulcerative colitis (UC) or indeterminate colitis
• CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
• Suspected or diagnosed intra-abdominal or perianal abscess at screening
• Current stoma or need for colostomy or ileostomy
• Previous small bowel resection with a combined resected length of >100 cm or previous colonic resection of > 2 segments
• Surgical bowel resection within 3 months before screening
• Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
• Participants in the opinion of the investigator are at an unacceptable risk for participation in the study
• Participants who meet the protocol criteria for important laboratory exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

55 participants in 3 patient groups

Induction Tulisokibart

Experimental group

Description:

During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1 of Week 0, and 500 mg on Day 1 of Weeks 2, 6, and 10.

Treatment:

Biological: Tulisokibart

Diagnostic Test: Companion Diagnostic (CDx)

OLE Tulisokibart 100 mg

Experimental group

Description:

After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion every 4 weeks (q4w).

Treatment:

Biological: Tulisokibart

OLE Tulisokibart 250 mg

Experimental group

Description:

After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.

Treatment:

Biological: Tulisokibart