NCT06997965

Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD

An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alimentiv Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.

Detailed description

This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD. This study will enroll adults (≥18 years of age) with a diagnosis of ileal or ileocolonic CD based upon radiologic, clinical, endoscopic, and histologic evidence with tolerable obstructive stricture symptoms. Participants will be recruited from approximately 15 sites in 2 countries (United States and Canada). This study consists of 3 study periods (screening period, open-label treatment period, and safety follow-up). After signing informed consent, potential study participants will be screened over a 5-week screening period, including MRE and ileocolonoscopy to confirm the presence of inflammatory strictures. Eligible participants will receive 900 mg mirikizumab IV Q4W to Week 12 and then 300 mg mirikizumab SC Q4W to Week 24. During screening and Week 24 visits, participants will undergo MRE for blinded MRE disease activity assessment with the MaRIA score and assessment of stricture features. At the same time points, ileocolonoscopy with biopsy collection (2 from the ileum, 2 from the rectum, and 2 from each colonic segment \[ascending, transverse, descending, and sigmoid\]; 12 biopsies total) will be performed for blinded endoscopic and histopathologic disease activity assessments with the SES-CD and RHI, respectively. Throughout the study, participants will undergo routine safety assessments at clinic visits, which will include physical examination, vital signs, clinical laboratory assessment, and recording of SAEs. At specified time points throughout the study, participants will complete a 7 day paper study diary consisting of patient reported items of the CDAI, UNRS, PGI-C, PGI-S, and the S-PRO. Blood samples will be collected at Weeks 12 and 24 for safety laboratory and CRP assessments. Stool samples will be collected at baseline and Week 24 for assessing FCP levels. The SIBDQ will be completed in-clinic at screening and Week 24. Participants will undergo a Safety Follow-up Visit 4 weeks after the last dose of study treatment for safety assessments and recording of SAEs, severe liver injury (ALT or AST ≥ 3 × ULN), serious infections, and CD-related complications. The safety follow-up visit can be performed by telephone, unless the participant has any ongoing AEs that require follow-up assessment.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Mirikizumab	Mirikizumab is an IL-23 antagonist.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-09-01
• Completion: 2028-04-01
• First posted: 2025-05-31
• Last updated: 2025-11-03

Regulatory

• FDA-regulated drug study