Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
Key facts
- Study ID
- NCT04987307
- Run by
- Amgen
- People needed
- 221
- Starts
- 2022-01-31
- Expected to finish
- 2024-10-22
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Birmingham Digestive Health Research, LLC — Homewood, Alabama, United States
- Arizona Health Research — Mesa, Arizona, United States
- Arizona Arthritis and Rheumatology Research, PLLC — Phoenix, Arizona, United States
- Southern California Research Center — Coronado, California, United States
- United Medical Doctors — Los Alamitos, California, United States
- Biopharma Informatic Incorporated — Los Angeles, California, United States
- Gastrointestinal Biosciences Clinical Trials Limited Liability Company — Los Angeles, California, United States
- University of California Irvine — Orange, California, United States
- Santa Maria Gastroenterology Medical Group — Santa Maria, California, United States
- Clinical Trials Management Services LLC — Thousand Oaks, California, United States
- Gastroenterology Center of Connecticut, PC — Hamden, Connecticut, United States
- West Central Gastroenterology — Clearwater, Florida, United States
- Homestead Associates In Research Inc — Homestead, Florida, United States
- Indian Health Service Health Research — Kissimmee, Florida, United States
- Lake Center for Clinical Research — Lady Lake, Florida, United States
- Auzmer Research — Lakeland, Florida, United States
- University of Miami Hospital and Clinic — Miami, Florida, United States
- Ocala Gastrointestinal Research, LLC — Ocala, Florida, United States
- AdventHealth Medical Group Gastroenterology and Hepatology — Orlando, Florida, United States
- Infigo Clinical Research — Sanford, Florida, United States
- Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
- Columbus Regional Research Institute, LLC — Columbus, Georgia, United States
- Grand Teton Research Group — Idaho Falls, Idaho, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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