A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505678-14-00

Acronym

M23-703

Enrollment

Registered

2024-07-23

Start date

2024-08-19

Completion date

Unknown

Last updated

2026-01-19

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

Conditions

Ulcerative Colitis

Brief summary

Percentage of Participants who Achieve Endoscopic Improvement at week 12

Detailed description

Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS) at week 12, Percentage of Participants who Achieve Clinical Response Per mMS at week 12, Percentage of Participants who Achieve Endoscopic Remission at week 12

Interventions

DRUGHumira 40 mg solution for injection in pre-filled syringe

DRUGLutikizumab

DRUGHumira 80 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of Participants who Achieve Endoscopic Improvement at week 12	—

Secondary

Measure	Time frame
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS) at week 12, Percentage of Participants who Achieve Clinical Response Per mMS at week 12, Percentage of Participants who Achieve Endoscopic Remission at week 12	—

Countries

Austria, Belgium, Bulgaria, Croatia, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Slovenia, Spain

Outcome results

None listed

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