Crohn DiseasePhase 4MIRIADNCT06997965
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
A Phase 4 study testing Mirikizumab in people with Crohn Disease, run by Alimentiv Inc. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Mirikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 20 Apr 2026to 1 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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
- Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines.
- Signed informed consent.
Who cannot join
- 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.
Show all 35Show fewer
- 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
- Total bilirubin > 1.5 × ULN
- 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.
- 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.
- 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.
- Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.
- 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.
- Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.
- Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.
- Prior enrolment in the current study and had received study treatment.
- 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.
- Unwillingness to withhold protocol-prohibited medications during the trial.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Jennifer Earle contact
8 sites in 2 countries
United States4 sites, 2 recruiting
- Active, not recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
- Recruiting
University of Miami
Miami, Florida, 33136
Priscilla Madero, pdm73@med.miami.edu
David Kerman
- Recruiting
Digestive & Liver Center of Florida
Orlando, Florida, 32825
Harinath Sheela, Dr, hsheela@dlcfl.com
- Active, not recruiting
Velocity Clinical- Salt Lake City
Salt Lake City, Utah, 84088
Canada4 sites, 3 recruiting
- Recruiting
McMaster University Medical Center
Hamilton, Ontario, L8N 3Z5
Jaiminkumar Patel, patej102@mcmaster.ca
Neeraj Narula
- Active, not recruiting
London Digestive Disease Institute
London, Ontario, N6K1M6
- Recruiting
The Office of Dr. Jason Reinglas
Scarborough Village, Ontario, M1B 3V4
Jason Reinglas
Jason Reinglas, Dr
- Recruiting
GI Institute Research Foundation
Vancouver, British Columbia, V6Z 2K5
Brian Bressler, brian_bressler@hotmail.com
Brian Bressler, Dr
About this study
Official title: An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease
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.
Read the detailed description
This is an open-label, single-arm, phase 4 study to assess the efficacy of mirikizumab in 18 years of age) with a diagnosis of ileal or ileocolonic CD based upon radiologic, clinical, endoscopic, and histologic evidence with tolerable obstructive symptoms. Participants will be recruited from approximately 25 sites in 3 countries (Canada, the United Kingdom [UK] and the United States [US]).
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 magnetic resonance enterography (MRE) and ileocolonoscopy to confirm the presence of inflammatory strictures. Eligible participants will receive 900 mg mirikizumab intravenously (IV) on Day 1 every 4 weeks (Q4W) to Week 8, and then 300 mg mirikizumab subcutaneously (SC) Q4W from Week 12 to Week 24. The primary endpoint will be assessed at Week 24.
During the screening visit, MRE will be used to confirm the presence of stricture with areas of edema, which represents a specific sign of moderate-to-severe histologic inflammation. Edema appears as areas of high signal intensity on T2 sequences with selective fat suppression.
During screening and Week 24 visits, participants will undergo blinded MRE disease activity assessment with the MaRIA and simplified MaRIA (sMaRIA) score and assessment of stricture items. At the same time points, ileocolonoscopy with biopsy collection (2 from the ileum and 2 from each of ascending, transverse, and descending colon and rectum segments, and 2 within [if feasible] or as close to the stricture of the terminal ileum as possible; 12 biopsies total) will be performed for blinded endoscopic and histopathologic disease activity assessments with the SES- CD and Robarts Histopathology Index (RHI), respectively.
Throughout the study, participants will undergo routine safety assessments at clinic visits, which will include physical examination, clinical laboratory assessment, and recording of serious adverse events (SAEs). At specified time points throughout the study, participants will complete patient-reported items of the CDAI/2-item PRO (PRO2)/ Harvey-Bradshaw Index (HBI), CD Obstructive Score (CDOS), stricture symptom-related questions, fecal Urgency Numerical Rating Scale (UNRS), Patient Global Impressions of Severity (PGI-S), PGI of Change (PGI-C), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and Symptoms and Impacts Questionnaire for CD (SIQ-CD) questionnaires in an electronic study diary for 7 days. Blood samples will be collected during screening and at Weeks 12 and 24 for safety laboratory and C-reactive protein (CRP) assessments. Stool samples will be collected at baseline and Week 24 for assessing fecal calprotectin (FCP) levels.
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 (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] 3 × upper limit of normal [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
- Being tested
- Mirikizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Also called Omvoh
Mirikizumab is an IL-23 antagonist.
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab | Other | Open-label mirikizumab 900mg IV Weeks 0,4, and 8 then mirikizumab 300mg SC Weeks 12, 16, 20, and 24. Receives: Drug: Mirikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD
Achievement of radiologic response (defined by a 25% improvement in stricture length and no worsening of prestenotic small bowel diameter or wall thickness OR 25% improvement in prestenotic small bowel diameter and no worsening of stricture length or wall thickness)
Measured: At week 24
Secondary outcomes (35)
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change in baseline in CDOS score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in CDOS score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in CDAI score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in CDAI score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PRO2 Score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PRO2 score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in HBI score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in HBI score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
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)
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Achievement of endoscopic response (defined by ≥ 50% reduction from baseline in SES-CD score)
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in SIBDQ score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in UNRS score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in UNRS score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in RHI score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Achievement of histological response (defined by a ≥ 50% reduction from baseline in RHI score)
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Achievement of CRP response (defined by ≥ 50% reduction from baseline in CRP levels)
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Achievement of CRP response (defined by ≥ 50% reduction from baseline in CRP levels)
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in CRP level
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in CRP level
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Achievement of FCP response (defined by ≥ 50% reduction from baseline in FCP level)
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in FCP level
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PGI-S score
Measured: At week 4
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PGI-S score
Measured: At week 8
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PGI-S score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PGI-S score
Measured: At week 16
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PGI-S score
Measured: At week 20
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Change from baseline in PGI-S score
Measured: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
PGI-S score
Measured: At week 4
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
PGI-S score
Measured: At week 8
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
PGI-S score
Measured: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
PGI-S score
Measured: At week 16
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
PGI-S score
Measured: At week 20
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
PGI-S score
Measured: At week 24
To evaluate the safety of mirikizumab in participants with stricturing CD
Occurrence of SAEs, severe liver injury (ALT or AST ≥ 3 × ULN), and serious infections
Measured: Through end of safety follow-up
To evaluate the safety of mirikizumab in participants with stricturing CD
CD-related complications
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start20 Apr 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alimentiv Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997965
- Sponsor's protocol ID
- ELI-02022
- Acronym
- MIRIAD
- Status last verified
- Oct 2026
- First submitted
- 22 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease
- ClinicalTrials.gov ID
- NCT06997965
- Acronym / sponsor ID
- MIRIAD / ELI-02022
- Conditions
- Crohn Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alimentiv Inc.University, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 efficacy of mirikizumab in 18 years of age) with a diagnosis of ileal or ileocolonic CD based upon radiologic, clinical, endoscopic, and histologic evidence with tolerable obstructive symptoms. Participants will be recruited from approximately 25 sites in 3 countries (Canada, the United Kingdom [UK] and the United States [US]).
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 magnetic resonance enterography (MRE) and ileocolonoscopy to confirm the presence of inflammatory strictures. Eligible participants will receive 900 mg mirikizumab intravenously (IV) on Day 1 every 4 weeks (Q4W) to Week 8, and then 300 mg mirikizumab subcutaneously (SC) Q4W from Week 12 to Week 24. The primary endpoint will be assessed at Week 24.
During the screening visit, MRE will be used to confirm the presence of stricture with areas of edema, which represents a specific sign of moderate-to-severe histologic inflammation. Edema appears as areas of high signal intensity on T2 sequences with selective fat suppression.
During screening and Week 24 visits, participants will undergo blinded MRE disease activity assessment with the MaRIA and simplified MaRIA (sMaRIA) score and assessment of stricture items. At the same time points, ileocolonoscopy with biopsy collection (2 from the ileum and 2 from each of ascending, transverse, and descending colon and rectum segments, and 2 within [if feasible] or as close to the stricture of the terminal ileum as possible; 12 biopsies total) will be performed for blinded endoscopic and histopathologic disease activity assessments with the SES- CD and Robarts Histopathology Index (RHI), respectively.
Throughout the study, participants will undergo routine safety assessments at clinic visits, which will include physical examination, clinical laboratory assessment, and recording of serious adverse events (SAEs). At specified time points throughout the study, participants will complete patient-reported items of the CDAI/2-item PRO (PRO2)/ Harvey-Bradshaw Index (HBI), CD Obstructive Score (CDOS), stricture symptom-related questions, fecal Urgency Numerical Rating Scale (UNRS), Patient Global Impressions of Severity (PGI-S), PGI of Change (PGI-C), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), and Symptoms and Impacts Questionnaire for CD (SIQ-CD) questionnaires in an electronic study diary for 7 days. Blood samples will be collected during screening and at Weeks 12 and 24 for safety laboratory and C-reactive protein (CRP) assessments. Stool samples will be collected at baseline and Week 24 for assessing fecal calprotectin (FCP) levels.
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 (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] 3 × upper limit of normal [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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab | Other | Drug: MirikizumabOpen-label mirikizumab 900mg IV Weeks 0,4, and 8 then mirikizumab 300mg SC Weeks 12, 16, 20, and 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
Key exclusion criteria (35 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirikizumabAlso: OmvohMirikizumab is an IL-23 antagonist. | Drug | Mirikizumab |
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 25% improvement in stricture length and no worsening of prestenotic small bowel diameter or wall thickness OR 25% improvement in prestenotic small bowel diameter and no worsening of stricture length or wall thickness)
35 secondary outcomes
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 4
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 8
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 16
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 20
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 4
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 8
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 12
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 16
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 20
To evaluate the efficacy of mirikizumab in improving symptoms in participants with inflammatory stricturing CD
Time frame: At week 24
To evaluate the safety of mirikizumab in participants with stricturing CD
Time frame: Through end of safety follow-up
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Inflammatory Bowel Disease, Crohn's Disease
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Earle contact
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirikizumab in people with Crohn Disease, run by Alimentiv Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Earle (jennifer.earle@alimentiv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of mirikizumab in inducing a radiologic response in participants with inflammatory stricturing CD (time frame: At week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.