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Clinical Trials in the USA / NCT07652294
Enrolling by invitation Phase 2

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

NCT07652294 · tracked via the Priya Life Science USA tracker
Sponsor
Spyre Therapeutics, Inc.
Phase
Phase 2
Started
2026-06-08
Last updated
2026-09-15

Condition(s) studied

Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative

Investigational drug(s) / intervention(s)

SPY001SPY002SPY003

SPY001: Experimental

SPY002: Experimental

SPY003: Experimental

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 medications: 1. Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate) 2. 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 3. Any marketed advanced therapy (ie, biologic or small molecule) 4. Any investigational therapy other than SPY123-201 study drug 5. Total parenteral nutrition 3. 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. 4. Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Site 012 Lancaster California
Site 035 Marrero Louisiana
Study Site 002 San Antonio Texas
Site 019 Tacoma Washington
Site 103 Rosario Santa Fe Province
Site 206 South Brisbane Queensland
Site 471 Ghent Oost-Vlaanderen
Site 531 Brno Czechia
Site 584 Kutaisi Georgia
Site 581 Tbilisi Georgia
Site 588 Tbilisi Georgia
Site 583 Tbilisi Georgia
Site 586 Tbilisi Georgia
Site 582 Tbilisi Georgia
Site 634 Athens Greece
Site 651 Budapest Hungary
Site 672 Negrar Verona
Site 424 Amman Jordan
Site 422 Irbid Jordan
Site 711 Chisinau Moldova
Site 753 Bydgoszcz Poland
Site 732 Bydgoszcz Poland
Site 740 Poznan Poland
Site 736 Rzeszów Poland
Site 744 Sopot Poland
Site 737 Szczecin Poland
Site 752 Tychy Poland
Site 754 Warsaw Poland
Site 731 Warsaw Poland
Site 738 Wroclaw Poland
Site 734 Wroclaw Poland
Site 742 Wroclaw Poland
Site 788 Timișoara Romania
Site 802 Belgrade Serbia
Site 801 Zrenjanin Serbia
Site 823 Bratislava Slovakia
Site 824 Prešov Slovakia
Site 353 Wŏnju Gangwon-do
Site 357 Busan South Korea
Site 361 Daegu South Korea

+ 12 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652294 on ClinicalTrials.gov ↗ ← All trials in the USA