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
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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