Spyre Therapeutics, Inc.
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study) who have completed Part A and are deemed to be receiving clinical benefit, completed Part B, or met escape criteria in Part B. The primary aim of this LTE study is to characterize the long-term safety of various investigational drugs, to offer participants the option to extend treatment if they are clinically benefiting, or if they have not achieved sufficient clinical benefit (particularly placebo insufficient responders), to offer the opportunity to…
Inclusion Criteria: Participants must meet 1 of the following criteria from Study SPY123-201: 1. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator 2. Completed Part B 3. Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period \[ITP\] or experienced disease worsening during the maintenance treatment period \[MTP\]). Exclusion Criteria: 1. Met any treatment discontinuation criteria from Study SPY123-201. 2. Is on any of the following prohibited m…
Experimental
Experimental
Experimental