RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 24 visits
  • Procedures mentioned: Biopsies, Physical exams, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Blood samples will be collected at Weeks 12 and 24 for safety laboratory and CRP assessments."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe mirikizumab is and how well it works in adults with Crohn’s disease that causes swelling and narrowing in the bowel. About 60 people will take part. Everyone will receive mirikizumab and know which drug they are getting.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older and are not pregnant or breastfeeding.
  • You have had Crohn’s disease in the small bowel, or both the small bowel and colon, for at least 3 months.
  • You have at least one swollen, narrowed area near the end of the small bowel that meets the study’s rules. It must be within reach of a bowel camera and confirmed by a special MRI scan.
  • You have belly pain after eating, limits on how much or what you can eat, or both.
  • Your blockage symptoms are manageable, and your weight has been stable for 4 weeks. You are not expected to need hospital care, a procedure to widen the bowel, surgery, or added treatment during the study.
  • You have taken oral steroids for at least 4 weeks before screening, within the study’s dose limits. You agree to start slowly lowering the dose 8 weeks after study treatment begins.
  • You may keep taking allowed Crohn’s medicines if your doses have been stable for the required time. You must agree to keep this treatment stable during the study.
  • You follow the study’s birth control rules and sign a form agreeing to take part.

Who can't join

  • You have certain bowel problems other than Crohn’s disease, abnormal cells in the colon lining, or an untreated problem absorbing bile acids, which help digest fat.
  • You have certain past bowel surgeries or Crohn’s complications. These include too little working small bowel, a bowel opening through the skin, certain abnormal tunnels near the narrowing, untreated or nearby pockets of infection, or severe swelling of the colon.
  • You had major surgery within 8 weeks before screening or plan to have it during the study. You have had cancer within 5 years, except for certain fully treated skin or early cervical cancers.
  • You have severe liver disease or liver blood tests above the study’s limits.
  • You recently used certain immune-system drugs, biologic drugs, JAK inhibitors, or another study treatment. Past failure to respond to or tolerate IL-23p19 drugs, any past anti-scarring treatment, or unwillingness to stop banned medicines may also rule you out.
  • Your vaccines are not up to date, or you have certain infections, such as HIV, hepatitis B or C, tuberculosis, C. difficile, or active CMV. Other serious, repeated, or hard-to-treat infections may also rule you out.
  • You have a known or suspected allergy or cannot tolerate mirikizumab or its ingredients. You cannot safely have the bowel MRI or may be allergic to medicines used for the scan.
  • You already received treatment in this study, or the study doctor finds another health condition, mental health condition, or test result that could make joining unsafe or affect the results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Nonpregnant, nonlactating adults, ≥ 18 years of age. 2. Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening. 3. 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. 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 Criteria: 1. 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. 2. 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. 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.

Study sites (2)

FL

UT