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

RecruitingPhase 2Ages 18 Years - 75 YearsAllSpyre Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of UC for โ‰ฅ3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening * Active UC with disease extent of โ‰ฅ15 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 โ‰ฅ1, and Mayo endoscopic subscore โ‰ฅ2 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
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What it tests

  • SPY001
  • SPY002
  • SPY003
  • Placebo
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Where

273 sites
Site 024
Canoga Park, United States
Site 023
La Jolla, United States
Site 012
Lancaster, United States
Site 033
Colorado Springs, United States
Site 007
Kissimmee, United States
029
Miami, United States
Site 038
Chicago, United States
Site 006
Kansas City, United States

โ€ฆand 265 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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