Chrohn's DiseasePhase 4NCT07659353
Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease
A Phase 4 study testing Mirikizumab and Azathioprine (AZA) in people with Chrohn's Disease, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The choice of drug therapy for Crohn's disease depends on several factors, such as the severity of the condition, the sections of the bowel affected, or the patient's previous treatment history. Conventional therapy consists of a short course of corticosteroid treatment followed by azathioprine therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chrohn's Disease
- What is being tested?
- Mirikizumab and Azathioprine (AZA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2026to 31 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given written informed consent prior to any study-specific procedures.
- Willing and able to complete the scheduled study assessments, including ileocolonoscopy and daily Diary entry.
- Willing to comply with contraception requirements (as specified in Section 7.7 Contraception requirements).
- Age 18-75 years.
- Naïve to thiopurines (azathioprine or 6-mercaptopurine) and methotrexate.
- Naïve to advanced therapies (targeted biologic or small-molecule therapies) for Crohn's disease or any other disease.
Show all 16Show fewer
- Early disease: Crohn's disease diagnosed per DGVS/ECCO criteria ≤12 months and ≥4 weeks before Week 0 (randomization).
- Prior 5-aminosalicylate (5-ASA) and/or oral glucocorticoid therapy with inadequate response, loss of response, or intolerance to the agent(s) received.
- If receiving systemic GC at screening start: cumulative systemic GC exposure prior to screening start should be ≤8 weeks, and prednisolone ≤20 mg/day (or equivalent) should be stable for ≥2 weeks before screening colonoscopy.
- Oral budesonide must be discontinued ≥2 weeks before screening colonoscopy. A switch to prednisolone is permitted. Oral mesalamine must be discontinued ≥2 weeks before screening colonoscopy.
- Evidence of active Crohn's disease at enrollment, defined as all of the following:
- CDAI 220-500 at screening and Week 0; and
- CRP > ULN and/or fecal calprotectin >250 μg/g measured during screening (Week -8 to Week 0); and
- Endoscopic activity on screening ileocolonoscopy (Week -8 to Week 0)
- No actively draining fistula at screening and baseline.
- No prior CD-related surgery
Who cannot join
- Acute severe/fulminant Crohn's disease requiring immediate inpatient management or urgent surgery at screening (e.g., obstructive complication with imminent surgery, perforation, draining fistula, uncontrolled sepsis/abscess, toxic megacolon).
- Oral and rectal 5-ASA or rectal steroids treatment within 2 weeks prior to screening colonoscopy.
- History of malignancy, except for non-melanoma skin cancer that has been successfully treated and considered cured at screening.
- Planned or foreseeable surgery at or before randomization (Week 0).
- Known thiopurine methyltransferase deficiency or known inherited mutated nudix hydrolase 15 (NUDT15) gene.
- Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
Show all 19Show fewer
- Diagnosis inconsistent with Crohn's disease, including ulcerative colitis, indeterminate colitis, microscopic colitis, or other non-CD inflammatory enteropathies.
- Clinically important active infection, including but not limited to hepatitis B, hepatitis C, HIV/AIDS, or active tuberculosis (TB).
- Detectable hepatitis B virus (HBV) DNA or hepatitis C virus (HCV) RNA at screening.
- Latent TB.
- Planned receipt of live or live-attenuated vaccines (including Bacillus Calmette-Guerin, BCG) during screening or the study.
- Systemic mycoses or parasitosis.
- Unstable or uncontrolled illness that could increase risk or confound efficacy assessment, including but not limited to cerebro-cardiovascular, respiratory, gastrointestinal (other than CD), hepatic, renal, endocrine, hematologic, neurological disorders, or active malignancy.
- Known systemic hypersensitivity to any study drug or any excipient, or prior acute systemic hypersensitivity to monoclonal antibodies that, in the investigator's judgment, precludes mirikizumab therapy.
- Women who are pregnant, lactating or planning pregnancy
- Employee of Lilly or any of the organizations involved with this study or study site personnel directly affiliated with this study and/or their immediate families.
- Participation in another interventional clinical trial involving an investigational product or nonapproved use of a drug within the 12 weeks before screening, or concurrent enrollment in any other clinical study or any other type of medical research judged not to be scientifically or medically compatible with this trial.
- Unwilling or unable to comply with eDiary/data-capture requirements or other study procedures for the duration of the study.
- Committed to an institution by judicial or administrative order.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Schleswig-Holstein
Kiel
Study Office, +4943150022202, study@ikmb.uni-kiel.de
About this study
Official title: Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial
The choice of drug therapy for Crohn's disease depends on several factors, such as the severity of the condition, the sections of the bowel affected, or the patient's previous treatment history. Conventional therapy consists of a short course of corticosteroid treatment followed by azathioprine therapy. Alternatively, there are so-called advanced therapies using biologics (biotechnologically produced protein substances such as antibodies), for example mirikizumab. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the standard therapy of azathioprine in combination with corticosteroids. Following an inclusion phase, patients will be randomly assigned to either treatment with mirikizumab or azathioprine + corticosteroids. Patients in the azathioprine arm may switch to mirikizumab therapy at three time points from week 24 onwards if they do not respond adequately to azathioprine therapy. The study consists of an initial treatment period of 12 weeks (induction therapy) and a maintenance therapy period of 40 weeks. Patients in the mirikizumab arm receive 13 doses of mirikizumab. This includes initially 900 mg intravenously every 4 weeks followed by 300 mg subcutaneously. In the azathioprine arm patients receive daily administration of azathioprine tablets in combination with a steroid. Assignment to one of the two treatment options is randomised with equal probability for each of the treatment options.
- Conditions
- Chrohn's Disease
- Being tested
- Mirikizumab, Azathioprine (AZA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Mirikizumab 900 mg intravenously at Weeks 0, 4, and 8, then 300 mg subcutaneously every 4 weeks starting Week 12 through Week 52
Azathioprine (AZA)Drug
Azathioprine 2.0-2.5 mg/kg/day plus GC induction
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab | Experimental | Not described Receives: Drug: Mirikizumab |
| Azathioprine | Active comparator | Not described Receives: Drug: Azathioprine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
deep remission at Week 52
Proportion of patients in deep remission at Week 52 (defined as patient level combination of all of the following: Clinical remission: CDAI <150, Endoscopic criterion: SES-CD ≤2 with no deep ulcers (central read), Steroid-free: no systemic glucocorticoids within 8 weeks prior to Week 52, No IBD-related surgery through Week 52, No actively draining fistula at Week 52 and no new fistula through Week 52, No new clinically relevant stenosis through Week 52
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chrohn's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659353
- Sponsor's protocol ID
- MIRAGE
- Other IDs
- 2026-525191-26-00
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07659353
- Acronym / sponsor ID
- MIRAGE
- Conditions
- Chrohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 22 Jun 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.
The choice of drug therapy for Crohn's disease depends on several factors, such as the severity of the condition, the sections of the bowel affected, or the patient's previous treatment history. Conventional therapy consists of a short course of corticosteroid treatment followed by azathioprine therapy. Alternatively, there are so-called advanced therapies using biologics (biotechnologically produced protein substances such as antibodies), for example mirikizumab. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the standard therapy of azathioprine in combination with corticosteroids. Following an inclusion phase, patients will be randomly assigned to either treatment with mirikizumab or azathioprine + corticosteroids. Patients in the azathioprine arm may switch to mirikizumab therapy at three time points from week 24 onwards if they do not respond adequately to azathioprine therapy. The study consists of an initial treatment period of 12 weeks (induction therapy) and a maintenance therapy period of 40 weeks. Patients in the mirikizumab arm receive 13 doses of mirikizumab. This includes initially 900 mg intravenously every 4 weeks followed by 300 mg subcutaneously. In the azathioprine arm patients receive daily administration of azathioprine tablets in combination with a steroid. Assignment to one of the two treatment options is randomised with equal probability for each of the treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab | Experimental | Drug: Mirikizumab |
| Azathioprine | Active comparator | Drug: Azathioprine (AZA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Given written informed consent prior to any study-specific procedures.
- Willing and able to complete the scheduled study assessments, including ileocolonoscopy and daily Diary entry.
- Willing to comply with contraception requirements (as specified in Section 7.7 Contraception requirements).
- Age 18-75 years.
- Naïve to thiopurines (azathioprine or 6-mercaptopurine) and methotrexate.
Key exclusion criteria (19 listed)
- Acute severe/fulminant Crohn's disease requiring immediate inpatient management or urgent surgery at screening (e.g., obstructive complication with imminent surgery, perforation, draining fistula, uncontrolled sepsis/abscess, toxic megacolon).
- Oral and rectal 5-ASA or rectal steroids treatment within 2 weeks prior to screening colonoscopy.
- History of malignancy, except for non-melanoma skin cancer that has been successfully treated and considered cured at screening.
- Planned or foreseeable surgery at or before randomization (Week 0).
- Known thiopurine methyltransferase deficiency or known inherited mutated nudix hydrolase 15 (NUDT15) gene.
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 |
|---|---|---|
| MirikizumabMirikizumab 900 mg intravenously at Weeks 0, 4, and 8, then 300 mg subcutaneously every 4 weeks starting Week 12 through Week 52 | Drug | Mirikizumab |
| Azathioprine (AZA)Azathioprine 2.0-2.5 mg/kg/day plus GC induction | Drug | Azathioprine |
Primary outcome
deep remission at Week 52
Time frame: Week 52
Proportion of patients in deep remission at Week 52 (defined as patient level combination of all of the following: Clinical remission: CDAI <150, Endoscopic criterion: SES-CD ≤2 with no deep ulcers (central read), Steroid-free: no systemic glucocorticoids within 8 weeks prior to Week 52, No IBD-related surgery through Week 52, No actively draining fistula at Week 52 and no new fistula through Week 52, No new clinically relevant stenosis through Week 52
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 22 Jun 2026.
Related trials for Chrohn's Disease
RecruitingObservational study
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel Disease, Ulcerative Colitis
Not yet recruitingObservational study
GPX4 Expression After Kono-S vs Conventional Anastomosis
Chrohn's 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.
1 site 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 Azathioprine (AZA) in people with Chrohn's Disease, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 16 inclusion and 19 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deep remission at Week 52 (time frame: Week 52). 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 22 Jun 2026.