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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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525191-26-00
Enrollment
320
Registered
2026-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-11

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

Conditions

Crohn’s disease

Brief summary

Proportion of patients in deep remission at Week 52 (mITT), 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.

Interventions

DRUGMIRIKIZUMAB
DRUG-
DRUGAZATHIOPRINE

Sponsors

Universitaetsklinikum Schleswig-Holstein AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients in deep remission at Week 52 (mITT), 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.—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 12, 2026