Crohn Disease
Mirikizumab for Crohn Disease With Inflammatory Strictures
This phase 4 study is investigating the safety and effects of mirikizumab in adults with Crohn disease, tolerable obstructive symptoms, and inflammatory intestinal strictures.
Registry title: Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Mirikizumab
- Design
- Not provided
- Central study contact
- Jennifer Earlejennifer.earle@alimentiv.com
- Sponsor
- Alimentiv Inc.
Research question
Does mirikizumab produce a radiologic response by week 24, and what safety findings and other disease changes occur, in people with inflammatory stricturing Crohn disease?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older who are not pregnant or breastfeeding.
- The study is looking for people with ileal or ileocolonic Crohn disease diagnosed at least three months before screening.
- The study is looking for people with at least one noncritical inflammatory stricture in or near the terminal ileum that meets the study's imaging and endoscopy requirements.
- The study is looking for people with tolerable obstructive symptoms, including pain after eating or limits on the amount or types of food eaten.
- Participants are being recruited at listed sites in the United States and Canada, although each site's current availability differs.
Participation overview
What participation may involve
Participation includes a five-week screening period, mirikizumab treatment through Week 24, repeated imaging and ileocolonoscopy, safety monitoring, questionnaires and diaries, blood and stool collection, and a safety follow-up four weeks after the final dose. What participation may involve: - Screening includes magnetic resonance enterography (MRE) and ileocolonoscopy to confirm inflammatory strictures. - Participants receive intravenous mirikizumab at Weeks 0, 4, and 8, then under-the-skin mirikizumab at Weeks 12, 16, 20, and 24. - MRE and ileocolonoscopy with 12 biopsies are performed during screening and at Week 24. - Clinic safety assessments include physical examinations, vital signs, laboratory tests, and recording of serious adverse events. - At specified times, participants complete seven-day paper diaries and other symptom and quality-of-life questionnaires. - Blood is collected at Weeks 12 and 24, and stool is collected at baseline and Week 24. The registry describes five weeks of screening, treatment through Week 24, and a safety follow-up visit four weeks after the last dose. Reported study time points include screening, treatment at Weeks 0, 4, 8, 12, 16, 20, and 24, and safety follow-up four weeks after the last dose. The complete number and schedule of clinic visits are not stated.
Study interventions
What participants may receive or do
- Mirikizumab: Mirikizumab, also listed as Omvoh, is described as an interleukin-23 antagonist. Participants receive 900 mg through an intravenous infusion at Weeks 0, 4, and 8, followed by 300 mg under-the-skin injections at Weeks 12, 16, 20, and 24.
Study design
How the comparison works
This is an open-label, phase 4 study in which approximately 60 participants are assigned to one group receiving mirikizumab. The registry lists allocation as not applicable and uses a single-group design, so participants are not assigned among multiple study groups. The study is open-label with no masking, meaning participants and the study team know that mirikizumab is being given. Imaging, endoscopic, and tissue-based disease activity assessments are described as blinded. There is no separate control or comparator group; results are assessed within the single mirikizumab group. No placebo intervention or placebo group is listed.
Reported activities
Procedures and tests
- Magnetic resonance enterography (MRE) during screening and at Week 24 assesses disease activity and stricture features.
- Ileocolonoscopy during screening and at Week 24 assesses endoscopic disease activity.
- During each reported ileocolonoscopy, 12 biopsies are collected from the ileum, rectum, and four colon segments for tissue-based assessment.
- Routine clinic safety checks include physical examinations, vital signs, clinical laboratory testing, and recording of serious adverse events.
- Seven-day paper diaries collect patient-reported symptom and disease-activity items at specified study times.
- Blood samples at Weeks 12 and 24 are used for safety laboratory testing and C-reactive protein assessment.
- Stool samples at baseline and Week 24 are used to assess fecal calprotectin.
- The Short Inflammatory Bowel Disease Questionnaire is completed in the clinic at screening and Week 24.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be nonpregnant, nonlactating adults age 18 or older.
- Ileal or ileocolonic Crohn disease must have been diagnosed at least three months before screening using clinical, endoscopic, and tissue evidence.
- At least one noncritical inflammatory stricture caused by Crohn disease must be in the terminal ileum and reachable by an endoscope, with central MRE confirmation of the specified features.
- The stricture must have localized narrowing and bowel-wall thickening, plus either dilation before the narrowing or inability to pass an adult colonoscope.
- Participants must have abdominal pain after eating and/or limits on how much or what types of food they eat.
- Obstructive symptoms must be tolerable, with no expected need for hospitalization, balloon dilation, surgery, or additional therapy during the study; weight must have been stable for four weeks before treatment.
- Participants taking oral corticosteroids must meet the stated dose and timing limits and be willing to taper them beginning eight weeks after study treatment starts.
- Permitted Crohn disease background therapy must be stable for the stated period and maintained during the study.
- Contraception must follow the mirikizumab product information and local guidelines.
Possible reasons someone may not be able to join
- Several other forms of colitis, colonic dysplasia, and untreated bile acid malabsorption are exclusionary.
- Certain prior bowel resections or anatomy, short bowel syndrome, an ostomy, or an ileoanal pouch are exclusionary.
- Specified fistulas, untreated active abdominal or perianal abscesses, an abscess near the stricture, or toxic megacolon are exclusionary.
- Major surgery within eight weeks before screening, or major surgery planned during the study, may exclude someone based on the investigator's judgment.
- Most malignancies within five years before initial screening are exclusionary, with the listed exceptions for certain adequately treated skin or cervical cancers.
- Decompensated liver disease or liver test results above the protocol's limits are exclusionary.
- Recent or ongoing use of specified immunosuppressants, biologics, Janus kinase inhibitors, or interleukin-23 p19 inhibitors is restricted according to different timing windows; prior nonresponse or intolerance to interleukin-23 p19 inhibitors is also exclusionary.
- Previous antifibrotic treatment, including an investigational antifibrotic therapy, is exclusionary.
- HIV, hepatitis B or C, active or latent tuberculosis, toxin-positive Clostridioides difficile, active cytomegalovirus, and other specified serious or recurring infections are exclusionary.
- An allergy or intolerance to mirikizumab or its ingredients is exclusionary.
- A contraindication to magnetic resonance enterography, or suspected allergy to its contrast agent or antispasmodic, is exclusionary.
Important unknowns
What the record does not make clear
- Several treatment and assessment weeks are reported, but the complete clinic-visit schedule and visit length are not provided.
- The registry lists permitted stable background therapies and requires them to remain stable, but it does not fully describe how every current Crohn disease treatment would be handled.
- Rescue therapy for a documented Crohn disease flare is tracked as a complication, but the available rescue-treatment plan is not described.
- The record does not state which study drugs, tests, procedures, or routine-care expenses are paid by the study or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not describe reimbursement or support for transportation, lodging, parking, or meals.
- The safety follow-up may occur by telephone unless ongoing adverse events require assessment, but the record does not say whether any other visits can be remote.
- The record does not state whether mirikizumab is available through the study after Week 24.
- The study is listed as recruiting overall, but some listed locations are recruiting while others are active but not recruiting.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, and how long should I expect the infusions, injections, imaging, and endoscopy visits to take?
- Which of my current Crohn disease medicines can continue, and what exact timing applies to medicines that are restricted?
- What happens if my obstructive symptoms worsen or I develop a Crohn disease flare during the study?
- What preparation, sedation, contrast, and recovery requirements apply to the two MRE and ileocolonoscopy assessments?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- Is the site nearest me currently screening participants, and can any activities besides safety follow-up be completed remotely?
- What care and treatment options are planned after the Week 24 dose and safety follow-up?
Before changing care
Questions for your gastroenterologist
- How might the study's medication restrictions and required corticosteroid taper affect my current Crohn disease treatment plan?
- Are my current stricture symptoms and nutritional status stable enough to discuss screening without delaying care that I may need?
- What approved treatment, endoscopic, or surgical alternatives should I understand before deciding whether to contact the study team?
- Do my prior surgeries, fistulas, abscess history, liver health, infections, or medication history raise concerns about the study procedures or mirikizumab?
- How should my regular gastroenterology care coordinate with the research team if symptoms worsen or urgent treatment is needed?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 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.
Study design and administration
- Organization
- Alimentiv Inc.
- Organization class
- Other
- Organization study ID
- ELI-02022
- Lead sponsor
- Alimentiv Inc.
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Other
Mirikizumab
Open-label mirikizumab 900mg IV Weeks 0,4, and 8 then mirikizumab 300mg SC Weeks 12, 16, 20, and 24.
Interventions: Drug: Mirikizumab
Interventions
Drug
Mirikizumab
Mirikizumab is an IL-23 antagonist.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (17)
- Nonpregnant, nonlactating adults, ≥ 18 years of age.Registry-derived · unreviewed
- Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.Registry-derived · unreviewed
- 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:Registry-derived · unreviewed
- Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); ANDRegistry-derived · unreviewed
- Bowel wall thickening (≥ 25% relative to adjacent bowel; ANDRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Abdominal pain after eating and/or limitations in the amount/types of food eaten.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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:Registry-derived · unreviewed
- Oral 5-ASA drugs or sulfasalazine ≤ 4.8 g per day, for ≥ 4 weeks prior to screeningRegistry-derived · unreviewed
- AZA, 6-MP, or MTX for ≥ 4 weeks prior to ScreeningRegistry-derived · unreviewed
- Any rectal therapy for treatment of CD for ≥ 4 weeks prior to screeningRegistry-derived · unreviewed
- Antidiarrheal drugs for ≥ 8 weeks prior to screeningRegistry-derived · unreviewed
- Bile acid sequestrants for ≥ 4 weeks prior to screeningRegistry-derived · unreviewed
- Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines.Registry-derived · unreviewed
- Signed informed consent.Registry-derived · unreviewed
Exclusion criteria (35)
- 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.Registry-derived · unreviewed
- CD-related complications:Registry-derived · unreviewed
- Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.Registry-derived · unreviewed
- Short bowel syndrome.Registry-derived · unreviewed
- Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.Registry-derived · unreviewed
- Abscess located \< 2 cm in relation to the stricture.Registry-derived · unreviewed
- Toxic megacolon.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.Registry-derived · unreviewed
- Liver chemistry parameters that exceed the following thresholds:Registry-derived · unreviewed
- ALT or AST \> 2 × ULNRegistry-derived · unreviewed
- Alkaline phosphatase \> 2.5 × ULNRegistry-derived · unreviewed
- Total bilirubin \> 1.5 × ULNRegistry-derived · unreviewed
- Concomitant use of the following medications during the screening period or throughout the study:Registry-derived · unreviewed
- Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.Registry-derived · unreviewed
- Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.Registry-derived · unreviewed
- JAK inhibitor within 4 weeks prior to screening and throughout the study.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.Registry-derived · unreviewed
- Systemic or opportunistic infections including:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).Registry-derived · unreviewed
- Active CMV infection, as per investigator judgementRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.Registry-derived · unreviewed
- Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.Registry-derived · unreviewed
- Prior enrolment in the current study and had received study treatment.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Unwillingness to withhold protocol-prohibited medications during the trial.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD
Time frame: At 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)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 4
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in health-related quality of life in participants with inflammatory stricturing CD
Time frame: At week 4
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in radiologic disease activity in participants with inflammatory stricturing CD
Time frame: At week 4
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in endoscopic disease activity in participants with inflammatory stricturing CD
Time frame: At week 4
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in histologic disease activity in participants with inflammatory stricturing CD
Time frame: At week 4
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 8
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change in baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 16
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 20
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in S PRO score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change from baseline in CDAI score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in CDAI score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change from baseline in PRO2 Score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in PRO2 score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change from baseline in HBI score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in HBI score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Achievement of endoscopic response (defined by ≥ 50% reduction from baseline in SES-CD score) AND radiographic improvement (defined by a ≥ 25% improvement from baseline in stricture MaRIA score)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Achievement of endoscopic response (defined by ≥ 50% reduction from baseline in SES-CD score)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in SIBDQ score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change from baseline in UNRS score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in UNRS score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in RHI score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Achievement of histological response (defined by a ≥ 50% reduction from baseline in RHI score)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Achievement of CRP response (defined by ≥ 50% reduction from baseline in CRP levels)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Achievement of CRP response (defined by ≥ 50% reduction from baseline in CRP levels)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change from baseline in CRP level
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in CRP level
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Achievement of FCP response (defined by ≥ 50% reduction from baseline in FCP level)
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in FCP level
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 4
Change from baseline in PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 8
Change from baseline in PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
Change from baseline in PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 16
Change from baseline in PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 20
Change from baseline in PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
Change from baseline in PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 4
PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 8
PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 16
PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 20
PGI-S score
Secondary outcome
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
PGI-S score
Secondary outcome
To evaluate the safety of mirikizumab in participants with stricturing CD
Time frame: Through end of safety follow-up
Occurrence of SAEs, severe liver injury (ALT or AST ≥ 3 × ULN), and serious infections
Secondary outcome
To evaluate the safety of mirikizumab in participants with stricturing CD
Time frame: Through end of safety follow-up defined as a composite of (1) CD-related surgery, (2) CD-related hospitalization, (3) CD-medication-related complication, and (4) rescue therapy for a documented CD-related flare
CD-related complications
Recruiting locations in the United States
Digestive & Liver Center of Florida
RecruitingOrlando, Florida, 32825, United States
Harinath Sheela, Drhsheela@dlcfl.com
This study also lists 3 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- May 31, 2025
- Primary completion
- Sep 1, 2027
- Overall completion
- Apr 1, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.