A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506004-93-00

Acronym

20170104

Enrollment

167

Registered

2024-05-31

Start date

2022-03-01

Completion date

2024-08-27

Last updated

2024-07-30

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

Conditions

Ulcerative Colitis (UC)

Brief summary

Clinical remission at week 12

Detailed description

Clinical response at week 12, Endoscopic remission at week 12, Symptomatic remission at week 12, Combined endoscopic remission and histologic remission of the colon tissue at week 12, Change from baseline in histological score at week 12 as measured by Geboes score, Treatment-emergent adverse events

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinical remission at week 12	—

Secondary

Measure	Time frame
Clinical response at week 12, Endoscopic remission at week 12, Symptomatic remission at week 12, Combined endoscopic remission and histologic remission of the colon tissue at week 12, Change from baseline in histological score at week 12 as measured by Geboes score, Treatment-emergent adverse events	—

Countries

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

Outcome results