A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501645-70-00

Acronym

M20-259

Enrollment

208

Registered

2023-06-06

Start date

2020-11-25

Completion date

Unknown

Last updated

2025-10-22

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

Conditions

Crohns Disease

Brief summary

Part 1: Clinical remission (non-inferiority) at Week 24: CDAI < 150, Part 1: Endoscopic remission (superiority) at Week 48: defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer, Part 2: Evaluation of long-term safety

Detailed description

Achievement of clinical remission (CDA < 150) at Week 48: superiority of risankizumab vs. ustekinumab., Achievement of endoscopic response at Week 48, superiority of risankizumab vs. ustekinumab, Achievement of endoscopic response at Week 24, superiority of risankizumab vs. ustekinumab, Achievement of steroid-free endoscopic remission Week 48, superiority of risankizumab vs. ustekinumab, Achievement of steroid-free clinical remission at Week 48, superiority of risankizumab vs. ustekinumab.

Interventions

DRUGSTELARA 90 mg solution for injection in pre-filled syringe

DRUGRisankizumab

DRUGSTELARA 130 mg concentrate for solution for infusion

DRUGABBV-066 / Risankizumab

DRUGABBV-066

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Clinical remission (non-inferiority) at Week 24: CDAI < 150, Part 1: Endoscopic remission (superiority) at Week 48: defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer, Part 2: Evaluation of long-term safety	—

Secondary

Measure	Time frame
Achievement of clinical remission (CDA < 150) at Week 48: superiority of risankizumab vs. ustekinumab., Achievement of endoscopic response at Week 48, superiority of risankizumab vs. ustekinumab, Achievement of endoscopic response at Week 24, superiority of risankizumab vs. ustekinumab, Achievement of steroid-free endoscopic remission Week 48, superiority of risankizumab vs. ustekinumab, Achievement of steroid-free clinical remission at Week 48, superiority of risankizumab vs. ustekinumab.	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain

Outcome results

None listed

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