NCT07235904
Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis
Recruiting · Phase 4 · University Hospital Schleswig-Holstein · registry updated 2025-12-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The MIRACLE trial is for patients who have been newly diagnosed with moderate to severe ulcerative colitis in the last 12 months and who have not responded adequately to treatment with mesalazine and prednisolone alone. The standard drug therapy for ulcerative colitis begins with mesalazine (+cortisone) and, if the response is insufficient, continues with azathioprine (+cortisone). Only in the next step are biologics (biotechnologically produced protein substances such as antibodies) such as mirikizumab used as needed. Recent studies have now shown that earlier treatment with mirikizumab without prior treatment with azathioprine may be more effective in the long term, and there are indications that this may result in fewer side effects. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the usual initiation of standard therapy with azathioprine, whereby these patients can then switch to mirikizumab at predetermined times during the course of the study from week 24 onwards if they have a defined disease activity despite the previous azathioprine treatment....
Inclusion
- Have given written informed consent prior to any study-specific procedures being completed.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- Are willing to comply with contraception requirements (as specified in section 7.7)
- Age between 18 and 75 years.
- Naïve to azathioprine and its metabolite 6-MP
- Naïve to advanced therapies.
Exclusion
- Fulminant ulcerative colitis patients who do not respond to steroid treatment or requiring \>20 mg of prednisolone (or equivalent) at baseline and/or fulfilling the criteria for severe UC (requirement of hospitalization) .
- Patients with complex UC who have required cyclosporine and tacrolimus for previous treatment
- Treatment with MTX within 8 weeks before baseline
- Rectal 5-ASA or rectal steroids treatment within 2 weeks prior to baseline
- History of malignancy, except for non-melanoma skin cancer.
- Planned or foreseeable surgery at the time of inclusion.