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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
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
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
Start Date
January 31, 2022
Primary Completion Date
October 22, 2024
Completion Date
October 22, 2024
Last Updated
January 13, 2026
221
ACTUAL participants
Efavaleukin alfa
DRUG
Placebo
DRUG
Lead Sponsor
Amgen
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009