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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525191-26-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab | Experimental |
| |
| Azathioprine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Mirikizumab 900 mg intravenously at Weeks 0, 4, and 8, then 300 mg subcutaneously every 4 weeks starting Week 12 through Week 52 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 52 |
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Inclusion Criteria:
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.
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:
No actively draining fistula at screening and baseline.
No prior CD-related surgery
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Schleswig-Holstein | Kiel | Germany |
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| Azathioprine (AZA) | Drug | Azathioprine 2.0-2.5 mg/kg/day plus GC induction |
|
| ID | Term |
|---|---|
| C000708407 | mirikizumab |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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