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

NCT06997965 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: ELI-02022
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD

  Achievement of radiologic response (defined by a ≥ 50% improvement in stricture length and no worsening of prestenotic small bowel diameter OR a ≥ 50% improvement in prestenotic small bowel diameter and no worsening of stricture length)

  At week 24

Secondary Outcomes (43)

• To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD

  At week 4

• To evaluate the efficacy of mirikizumab in health-related quality of life in participants with inflammatory stricturing CD

  At week 4

• To evaluate the efficacy of mirikizumab in radiologic disease activity in participants with inflammatory stricturing CD

  At week 4

• To evaluate the efficacy of mirikizumab in endoscopic disease activity in participants with inflammatory stricturing CD

  At week 4

• To evaluate the efficacy of mirikizumab in histologic disease activity in participants with inflammatory stricturing CD

  At week 4

Study Arms (1)

Mirikizumab

OTHER

Open-label mirikizumab 900mg IV Weeks 0,4, and 8 then mirikizumab 300mg SC Weeks 12, 16, 20, and 24.

Drug: Mirikizumab

Interventions

Mirikizumab DRUG

Mirikizumab is an IL-23 antagonist.

Also known as: Omvoh

Mirikizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonpregnant, nonlactating adults, ≥ 18 years of age.
• Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.
• Presence of at least 1 inflammatory stricture in the terminal ileum\* within reach of an endoscope (passable or nonpassable). Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:
• Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND
• Bowel wall thickening (≥ 25% relative to adjacent bowel; AND
• Either prestenotic dilation (defined as a luminal diameter ≥ 3 cm) or nonpassable with adult colonoscope \*Note: The terminal ileum is defined as the last 15 cm of ileum proximal to the ileocecal valve or ileocolonic anastomosis. Other small bowel strictures will be considered on a case-by-case basis following discussion with the sponsor. Two strictures within 3 cm are considered the same stricture, and a long segment with multiple areas of narrowing or multiple strictures, that have inflammation between them, is counted as 1 stricture.
• Abdominal pain after eating and/or limitations in the amount/types of food eaten.
• Presence of tolerable obstructive symptoms and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study period. Participants should have sufficient food intake, even with diet modification, defined as a stable weight over 4 weeks prior to initiation of study intervention.
• Participants taking oral corticosteroids (eg, ≤ 20 mg/day prednisone or ≤ 9 mg/day budesonide) for ≥ 4 weeks prior to screening. Participants must be willing to undergo corticosteroid taper 8 weeks after initiation of study intervention as per standard of care.
• Participants can be on stable background therapy for CD and must agree to maintain the background therapy during the study. Acceptable stable background therapies include:
• Oral 5-ASA drugs or sulfasalazine ≤ 4.8 g per day, for ≥ 4 weeks prior to screening
• AZA, 6-MP, or MTX for ≥ 4 weeks prior to Screening
• Any rectal therapy for treatment of CD for ≥ 4 weeks prior to screening
• Antidiarrheal drugs for ≥ 8 weeks prior to screening
• Bile acid sequestrants for ≥ 4 weeks prior to screening

You may not qualify if:

• History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
• CD-related complications:
• Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.
• Short bowel syndrome.
• Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
• Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of peri-anal abscess \> 2 cm.
• Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.
• Abscess located \< 2 cm in relation to the stricture.
• Toxic megacolon.
• Any major surgery, in the investigator's opinion, performed within 8 weeks prior to screening or planned during the study (ie, any surgical procedure requiring general anesthesia).
• Malignancies or history of malignancy within 5 years of the initial screening visit, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.
• Liver chemistry parameters that exceed the following thresholds:
• ALT or AST \> 2 × ULN
• Alkaline phosphatase \> 2.5 × ULN

Sponsors & Collaborators

• Alimentiv Inc.: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Susan Archer

CONTACT

226-919-6959; susan.archer@alimentiv.com

Anna Cheng

CONTACT

416-705-3688; anna.cheng@alimentiv.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 3, 2025

Record last verified: 2025-10