Trial · NCT07235904
Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis
NCT07235904, Phase 4, Recruiting, University Hospital Schleswig-Holstein
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis. Trials, record NCT07235904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07235904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis
- NCT number
- NCT07235904
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 300 participants, estimated
- Lead sponsor
- University Hospital Schleswig-Holstein
- Conditions
- Ulcerative Colitis (UC)
- Interventions
- Mirikizumab, Azathioprine (AZA)
- First posted
- 2025-11-19
- Last updated
- 2025-12-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | comprehensive disease control | Week 52 | The proportion of patients achieving comprehensive disease control at Week 52, defined as: Steroid-free clinical remission (modified Mayo score remission \[ES ≤1, SF ≤1, RB=0\] and no glucocorticoid use for at least 12 weeks prior to week 52) achieved without surgery, and Biochemical remission (CRP \<0.5 mg/dl and Fcal \<250 μg/g stool), and Endoscopic improvement (eMayo=0-1), and Histologic remission (RHI ≤3, with subscores of 0 for lamina propria neutrophils and of 0 for neutrophils in epithelium), and Normalization of IBD-related QoL (sIBDQ ≥60 points). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07235904
GET https://conductscience.org/api/trials/v1/NCT07235904/registered