Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD

Enrolling by invitation · Phase 2

Conditions studied: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative

In brief

This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).

Key facts

Study ID

NCT07652294

Run by

Spyre Therapeutics, Inc.

People needed

645

Starts

2026-06-08

Expected to finish

2030-01-03

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet 1 of the following criteria from Study SPY123-201:
• Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
• Completed Part B
• 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]).

You may not qualify if…

• Met any treatment discontinuation criteria from Study SPY123-201.
• Is on any of the following prohibited medications:
• Immunosuppressants (eg, azathioprine, 6-mercaptopurine [6-MP], or methotrexate)
• Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects
• Any marketed advanced therapy (ie, biologic or small molecule)
• Any investigational therapy other than SPY123-201 study drug
• Total parenteral nutrition
• Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
• Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Where it is running

• Study Site 002 — San Antonio, Texas, United States
• Site 531 — Brno, Czechia
• Site 584 — Kutaisi, Georgia
• Site 583 — Tbilisi, Georgia
• Site 586 — Tbilisi, Georgia
• Site 634 — Athens, Greece
• Site 736 — Rzeszów, Poland
• Site 752 — Tychy, Poland
• Site 754 — Warsaw, Poland
• Site 731 — Warsaw, Poland
• Site 738 — Wroclaw, Poland
• Site 802 — Belgrade, Serbia
• Site 353 — Wŏnju, Gangwon-do, South Korea
• Site 356 — Seoul, South Korea
• Site 396 — Taichung, Taiwan

Full record on ClinicalTrials.gov

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