Efficacy of top-down therapy with mirikizumab versus standard of care with azathioprine in patients with newly diagnosed moderate-to-severe ulcerative colitis: A 52-week, multicenter, open-label, randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522585-72-00

Acronym

MIRACLE

Enrollment

300

Registered

2025-09-26

Start date

2025-12-05

Completion date

Unknown

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Brief summary

The proportion of patients achieving comprehensive disease control at Week 52.

Interventions

DRUGAZATHIOPRINE

DRUG-

DRUGMIRIKIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients achieving comprehensive disease control at Week 52.	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026