NCT06997965
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
Recruiting
PHASE4Ages 18+InterventionalTreatmentAlimentiv Inc.Investigator-initiated
~60 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Mirikizumab
At a glance
Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD
Measured over At week 24
Conditions
Where it's being run
5 sites across 4 statesOntario2
Florida1
Utah1
British Columbia1
Who to contact
Jennifer Earle
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Eligibility criteria
Inclusion
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. 4. Abdominal pain after eating and/or limitations in the amount/types of food eaten. 5. 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. 6. 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. 7. 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 8. Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines. 9. Signed informed consent.
Exclusion
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. 3. 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). 4. 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. 5. Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury. 6. Liver chemistry parameters that exceed the following thresholds:
ALT or AST \> 2 × ULN
Alkaline phosphatase \> 2.5 × ULN
Total bilirubin \> 1.5 × ULN 7. Concomitant use of the following medications during the screening period or throughout the study:
Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.
Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.
JAK inhibitor within 4 weeks prior to screening and throughout the study.
IL23p19 inhibitor within 4 weeks (or 5 half-lives, whichever is longer) prior to screening, or a history of nonresponse or intolerance to IL23p19 inhibitors. 8. Not up-to-date with current age-appropriate vaccinations in accordance with current immunization guidelines and the investigator's usual standard of care at screening. 9. Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening. 10. Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies. 11. Systemic or opportunistic infections including:
HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to Day 0, retesting is not required.
Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before Day 0.
Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).
Active CMV infection, as per investigator judgement
Other systemic or opportunistic infection, any other clinically significant extraintestinal infection, infection that is not responding to standard treatment, or recurring infection within 6 months of Day 1. 12. Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients. 13. Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic. 14. Prior enrolment in the current study and had received study treatment. 15. Any acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study intervention administration, or may interfere with the interpretation of study results, as determined by the investigator. 16. Unwillingness to withhold protocol-prohibited medications during the trial.
What this trial measures
- To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CDAt week 24
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)