Crohn's DiseasePhase 4MIRICURENCT07782021
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
A Phase 4 study testing Mirikizumab and Fistula Tract Curettage and Closure in people with Crohn's Disease and Perianal Fistula, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Perianal Fistula
- What is being tested?
- Mirikizumab and Fistula Tract Curettage and Closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to Jul 2029
- 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
- Adults ≥18 years
- Diagnosis of Crohn disease for at least 3 months
- Active draining complex perianal fistula
- Able to provide informed consent
Who cannot join
- Rectovaginal fistula
- Only low intersphincteric or submucosal fistulas
- Severe proctitis preventing surgical closure
- Stoma
- Active tuberculosis
- Active hepatitis B
Show all 11Show fewer
- Active serious infection
- Pregnancy
- Concurrent investigational drug trial
- MRI contraindication
- Additional laboratory exclusions as specified in the protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Washington University in St. Louis
Louis, Missouri, 63130
Parakkal Deepak, MBBS, MS, 314-273-1947, deepak.parakkal@wustl.edu
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Serre-Yu Wong, MD, PhD, 212-241-3179, serre-yu.wong@mountsinai.org
Serre-Yu Wong, MD, PhD
About this study
This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease. Fifty participants with complex draining fistulas will undergo staged surgical management followed by mirikizumab induction and maintenance therapy. The primary endpoint is combined clinical remission and radiologic response at Week 24. Participants will be followed through Week 48.
Read the detailed description
Perianal fistulizing Crohn disease is a severe manifestation of Crohn disease associated with persistent fistula drainage, impaired quality of life, and substantial morbidity. Although biologic therapies have improved outcomes, durable fistula healing remains uncommon, and optimal treatment strategies continue to be defined.
Mirikizumab is an interleukin-23 p19 antagonist approved for the treatment of moderately to severely active Crohn disease. Surgical management, including fistula tract curettage and closure of the internal opening, has demonstrated favorable outcomes when incorporated into multidisciplinary treatment approaches for complex perianal fistulas.
This Phase 4, multicenter, single-arm, open-label study will enroll approximately 50 adults with active complex perianal fistulizing Crohn disease. Participants will undergo examination under anesthesia with fistula tract curettage and seton placement prior to initiation of mirikizumab induction therapy. After 8 to 10 weeks of treatment, participants will undergo repeat examination under anesthesia with seton removal, repeat curettage, and closure of the internal fistula opening. Participants will receive mirikizumab induction followed by maintenance therapy and will be followed for 48 weeks.
Pelvic MRI will be performed at Weeks 12, 24, and 48 and evaluated using standardized MAGNIFI-CD and TOpCLASS criteria. Clinical assessments, patient-reported outcome measures, safety evaluations, and quality-of-life assessments will be collected throughout the study.
The primary objective is to evaluate the proportion of participants achieving combined clinical remission and radiologic response at Week 24. Secondary objectives include evaluation of clinical remission, radiologic remission, fistula healing, quality of life, disease activity, and safety through Week 48.
- Conditions
- Crohn's Disease, Perianal Fistula
- Being tested
- Mirikizumab, Fistula Tract Curettage and Closure
- Keywords
- Perianal Fistula, Perianal Fistulizing Crohn's Disease, Mirikizumab, Interleukin-23 inhibitor, Magnetic resonance imaging, Crohn's Disease
- 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 administered as a 900 mg intravenous infusion at Weeks 0, 4, and 8, followed by a 300 mg subcutaneous maintenance injection beginning at Week 12 and every 4 weeks thereafter through the end of the study.
Fistula Tract Curettage and ClosureProcedure or surgery
Participants undergo an initial examination under anesthesia with fistula tract curettage and seton placement before initiation of mirikizumab therapy. After 8 to 10 weeks of induction therapy, participants undergo a second examination under anesthesia with seton removal, repeat fistula tract curettage, and closure of the internal fistula opening(s).
| Study group | Role | What they receive |
|---|---|---|
| Participants with active perianal fistulizing Crohn disease | Experimental | Participants receive mirikizumab in combination with staged surgical management for active perianal fistulizing Crohn disease. Receives: Drug: Mirikizumab; Procedure: Fistula Tract Curettage and Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving combined clinical remission and radiologic response
Proportion of participants achieving combined clinical remission and radiologic response.
Clinical remission is defined as complete closure of all treated external fistula openings without spontaneous drainage or drainage upon gentle finger compression and without development of new fistulas or abscesses greater than 1 cm.
Radiologic response is defined using MAGNIFI-CD criteria as greater than 50% reduction in MAGNIFI-CD score together with improvement in fibrosis-to-fluid ratio compared with baseline MRI. The MAGNIFI-CD is an MRI-based composite index that assesses perianal fistulizing Crohn disease activity using six weighted domains, including fistula complexity, tract length, fistula composition, tract enhancement, extension, and inflammatory mass/abscess. Total scores range from 0 to 25, with higher scores indicating greater disease activity and lower scores indicating improvement.
Measured: Week 24
Secondary outcomes (1)
Proportion of participants achieving combined clinical remission and radiologic response
Proportion of participants achieving combined clinical remission and radiologic response.
Clinical remission is defined as complete closure of all treated external fistula openings without spontaneous drainage or drainage upon gentle finger compression and without development of new fistulas or abscesses greater than 1 cm.
Radiologic response is defined using MAGNIFI-CD criteria as greater than 50% reduction in MAGNIFI-CD score together with improvement in fibrosis-to-fluid ratio compared with baseline MRI. The MAGNIFI-CD is an MRI-based composite index that assesses perianal fistulizing Crohn disease activity using six weighted domains, including fistula complexity, tract length, fistula composition, tract enhancement, extension, and inflammatory mass/abscess. Total scores range from 0 to 25, with higher scores indicating greater disease activity and lower scores indicating improvement.
Measured: 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Model description
- All participants are assigned to a single treatment group receiving mirikizumab in combination with staged surgical curettage and closure for active perianal fistulizing Crohn's disease.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serre-Yu Wong, Icahn School of Medicine at Mount Sinai
- Investigators
- Serre-Yu Wong, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiParakkal Deepak, MBBS, MS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782021
- Sponsor's protocol ID
- SW-1
- Acronym
- MIRICURE
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
- ClinicalTrials.gov ID
- NCT07782021
- Acronym / sponsor ID
- MIRICURE / SW-1
- Conditions
- Crohn's Disease, Perianal Fistula
- Keywords
- Perianal Fistula, Perianal Fistulizing Crohn's Disease, Mirikizumab, Interleukin-23 inhibitor, Magnetic resonance imaging, Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Washington University School of Medicine
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Aug 2026 (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 Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease. Fifty participants with complex draining fistulas will undergo staged surgical management followed by mirikizumab induction and maintenance therapy. The primary endpoint is combined clinical remission and radiologic response at Week 24. Participants will be followed through Week 48.
Detailed description
Perianal fistulizing Crohn disease is a severe manifestation of Crohn disease associated with persistent fistula drainage, impaired quality of life, and substantial morbidity. Although biologic therapies have improved outcomes, durable fistula healing remains uncommon, and optimal treatment strategies continue to be defined.
Mirikizumab is an interleukin-23 p19 antagonist approved for the treatment of moderately to severely active Crohn disease. Surgical management, including fistula tract curettage and closure of the internal opening, has demonstrated favorable outcomes when incorporated into multidisciplinary treatment approaches for complex perianal fistulas.
This Phase 4, multicenter, single-arm, open-label study will enroll approximately 50 adults with active complex perianal fistulizing Crohn disease. Participants will undergo examination under anesthesia with fistula tract curettage and seton placement prior to initiation of mirikizumab induction therapy. After 8 to 10 weeks of treatment, participants will undergo repeat examination under anesthesia with seton removal, repeat curettage, and closure of the internal fistula opening. Participants will receive mirikizumab induction followed by maintenance therapy and will be followed for 48 weeks.
Pelvic MRI will be performed at Weeks 12, 24, and 48 and evaluated using standardized MAGNIFI-CD and TOpCLASS criteria. Clinical assessments, patient-reported outcome measures, safety evaluations, and quality-of-life assessments will be collected throughout the study.
The primary objective is to evaluate the proportion of participants achieving combined clinical remission and radiologic response at Week 24. Secondary objectives include evaluation of clinical remission, radiologic remission, fistula healing, quality of life, disease activity, and safety through Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are assigned to a single treatment group receiving mirikizumab in combination with staged surgical curettage and closure for active perianal fistulizing Crohn's disease.
| Arm | Type | Receives |
|---|---|---|
| Participants with active perianal fistulizing Crohn disease | Experimental | Drug: Mirikizumab, Procedure: Fistula Tract Curettage and ClosureParticipants receive mirikizumab in combination with staged surgical management for active perianal fistulizing Crohn disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years
- Diagnosis of Crohn disease for at least 3 months
- Active draining complex perianal fistula
- Able to provide informed consent
Key exclusion criteria (11 listed)
- Rectovaginal fistula
- Only low intersphincteric or submucosal fistulas
- Severe proctitis preventing surgical closure
- Stoma
- Active tuberculosis
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 administered as a 900 mg intravenous infusion at Weeks 0, 4, and 8, followed by a 300 mg subcutaneous maintenance injection beginning at Week 12 and every 4 weeks thereafter through the end of the study. | Drug | Participants with active perianal fistulizing Crohn disease |
| Fistula Tract Curettage and ClosureParticipants undergo an initial examination under anesthesia with fistula tract curettage and seton placement before initiation of mirikizumab therapy. After 8 to 10 weeks of induction therapy, participants undergo a second examination under anesthesia with seton removal, repeat fistula tract curettage, and closure of the internal fistula opening(s). | Procedure or surgery | Participants with active perianal fistulizing Crohn disease |
Primary outcome
Proportion of participants achieving combined clinical remission and radiologic response
Time frame: Week 24
Proportion of participants achieving combined clinical remission and radiologic response. Clinical remission is defined as complete closure of all treated external fistula openings without spontaneous drainage or drainage upon gentle finger compression and without development of new fistulas or abscesses greater than 1 cm. Radiologic response is defined using MAGNIFI-CD criteria as greater than 50% reduction in MAGNIFI-CD score together with improvement in fibrosis-to-fluid ratio compared with baseline MRI. The MAGNIFI-CD is an MRI-based composite index that assesses perianal fistulizing Crohn disease activity using six weighted domains, including fistula complexity, tract length, fistula composition, tract enhancement, extension, and inflammatory mass/abscess. Total scores range from 0 to 25, with higher scores indicating greater disease activity and lower scores indicating improvement.
1 secondary outcome
Proportion of participants achieving combined clinical remission and radiologic response
Time frame: 48 week
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 24 Aug 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Serre-Yu Wong, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Parakkal Deepak, MBBS, MS principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirikizumab and Fistula Tract Curettage and Closure in people with Crohn's Disease and Perianal Fistula, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Serre-Yu Wong, MD, PhD (212-241-3179, serre-yu.wong@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving combined clinical remission and radiologic response (time frame: 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 24 Aug 2026.