Terminated/Withdrawn
Sponsor ID
20210210
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Study Details
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).
Protocol Summary
Primary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 to Week 110
Secondary Outcome Measures
Number of Participants with Clinical Response at Week 52
Timeframe: Week 52
Number of Participants with Clinical Response at Week 104
Timeframe: Week 104
Number of Participants with Clinical Remission at Week 52
Timeframe: Week 52
Number of Participants with Clinical Remission at Week 104
Timeframe: Week 104
Number of Participants with Durable Clinical Remission at Week 52
Timeframe: Week 52
Number of Participants with Durable Clinical Remission at Week 104
Timeframe: Week 104
Number of Participants with Endoscopic Remission at Week 52
Timeframe: Week 52
Number of Participants with Endoscopic Remission at Week 104
Timeframe: Week 104
Number of Participants with Histologic Remission at Week 52
Timeframe: Week 52
Number of Participants with Histologic Remission at Week 104
Timeframe: Week 104
Number of Participants with Corticosteroid-free Remission
Timeframe: Week 52
Number of Participants with Corticosteroid-free Remission
Timeframe: Week 104
Number of Participants with Combined Endoscopic and Histologic Remission at Week 52
Timeframe: Week 52
Number of Participants with Combined Endoscopic and Histologic Remission at Week 104
Timeframe: Week 104
Number of Participants with Symptomatic Remission at Week 52
Timeframe: Week 52
Number of Participants with Symptomatic Remission at Week 104
Timeframe: Week 104
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
Timeframe: Baseline of Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks)
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104
Timeframe: Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)
Study Documents
Plain Language Summary of Results
Available Language(s): English, German, Danish, Spanish (Mexico), Spanish (Argentina), Polish, Bulgarian, Korean, Romanian, Japanese, Turkish, Hungarian, French
Locations
Location
Intesto BE
Bern, Switzerland, 3012
Status
Terminated
Location
University of Kansas Medical Center
Kansas City, KS, United States, 66160
Status
Recruiting
Location
Santa Maria Gastroenterology Medical Group
Santa Maria, CA, United States, 93458
Status
Recruiting
Location
Spitalul Clinic Colentina
Bucuresti, Romania, 020125
Status
Recruiting
Location
Cer Instituto Medico
Quilmes, Buenos Aires, Argentina, B1878DVB
Status
Recruiting
Location
Nagasaki University Hospital
Nagasaki-shi, Nagasaki, Japan, 852-8501
Status
Recruiting
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