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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

NCT07012395 · Spyre Therapeutics, Inc.
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Official title
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
About this study
This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts. Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. Intervention arms will be added to the study over time and may complete at different times.
Eligibility criteria
Inclusion Criteria: * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening * Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis) * Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2 Exclusion Criteria: * Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined * Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction * Failed 4 or more approved or investigational advanced therapy classes
Study design
Enrollment target: 645 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-05-27
Estimated completion: 2028-03
Last updated: 2026-04-14
Interventions
Drug: SPY001Drug: SPY002Drug: SPY003Other: Placebo
Primary outcomes
  • Part A: Change in Robarts Histopathology Index (RHI) (Week 12)
  • Part B: Percentage of participants with clinical remission (Week 12)
Sponsor
Spyre Therapeutics, Inc. · industry
Contacts & investigators
ContactSKYLINE-UC Trial Center · contact · info@skyline-uc.com · 1-650-402-4238
InvestigatorSKYLINE-UC Study Director · study_director, Spyre Therapeutics
All locations (148)
Site 024Recruiting
Canoga Park, California, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Colorado Springs, Colorado, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Kansas City, Kansas, United States
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Marrero, Louisiana, United States
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Glen Burnie, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Chapel Hill, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Providence, Rhode Island, United States
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Kingsport, Tennessee, United States
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Cedar Park, Texas, United States
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Garland, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Webster, Texas, United States
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Tacoma, Washington, United States
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Concord, Australia
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Heidelberg, Australia
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Liverpool, Australia
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South Brisbane, Australia
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Woolloongabba, Australia
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Linz, Austria
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Banja Luka, Bosnia and Herzegovina
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Mostar, Bosnia and Herzegovina
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Sarajevo, Bosnia and Herzegovina
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Gorna Oryahovitsa, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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London, Ontario, Canada
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Greater Sudbury, Canada
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London, Canada
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Brno, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Kutaisi, Georgia
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Marneuli, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Berlin, Germany
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Athens, Greece
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Athens, Greece
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Chaïdári, Greece
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Budapest, Hungary
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Budapest, Hungary
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Székesfehérvár, Hungary
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Hyderabad, India
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Jaipur, India
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Kochi, India
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Sūrat, India
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Beer Yaaqov, Israel
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Nahariya, Israel
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Negrar, Italy
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Turin, Italy
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Irbid, Jordan
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Chisinau, Moldova
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Chisinau, Moldova
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Chisinau, Moldova
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Chisinau, Moldova
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Chisinau, Moldova
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Bydgoszcz, Poland
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Bydgoszcz, Poland
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Katowice, Poland
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Katowice, Poland
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Krakow, Poland
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Opole, Poland
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Poznan, Poland
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Rzeszów, Poland
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Sopot, Poland
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Staszów, Poland
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Szczecin, Poland
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Szczecin, Poland
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Tychy, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Constanța, Romania
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Belgrade, Serbia
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Belgrade, Serbia
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Belgrade, Serbia
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Belgrade, Serbia
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Niš, Serbia
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Užice, Serbia
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Zrenjanin, Serbia
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Bratislava, Slovakia
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Košice, Slovakia
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Prešov, Slovakia
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Zvolen, Slovakia
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Busan, South Korea
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Daegu, South Korea
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Daegu, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Wŏnju, South Korea
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Madrid, Spain
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Madrid, Spain
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Ourense, Spain
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Basel, Switzerland
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Bern, Switzerland
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Sankt Gallen, Switzerland
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Changhua, Taiwan
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Chiayi City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Ivano-Frankivsk, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis · TrialPath