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

NCT07012395

RecruitingPhase 2

Sponsor: Spyre Therapeutics, Inc.

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

Interventions: SPY001, SPY002, SPY003, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (259)
  • Canoga Park, California, United States
  • La Jolla, California, United States
  • Lancaster, California, United States
  • Colorado Springs, Colorado, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Louisville, Kentucky, United States
  • Marrero, Louisiana, United States
  • Glen Burnie, Maryland, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Providence, Rhode Island, United States
  • Kingsport, Tennessee, United States
  • Cedar Park, Texas, United States
  • Garland, Texas, United States
  • San Antonio, Texas, United States
  • Southlake, Texas, United States
  • Webster, Texas, United States
  • Seattle, Washington, United States
  • Tacoma, Washington, United States
  • La Plata, Buenos Aires, Argentina
  • Lujan de Cuyo, Mendoza Province, Argentina
  • Rosario, Sant Fe, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • + 229 more on CT.gov