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Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)

Study testing ATH-063 for hard-to-treat ulcerative colitis.

Recruiting
18-75 years
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)
Study Summary: This study examines a new treatment, ATH-063, for people with moderate to severe ulcerative colitis (UC), a condition causing inflammation in the colon. Participants will go through three phases: a 4-week screening, a 12-week treatment, and an optional open-label extension where everyone knows the treatment being given. Key Points:
  • Participants will receive either ATH-063 or a placebo (a harmless pill with no medicine) for 12 weeks.
  • Afterward, participants can choose to continue in an open-label phase (12 more weeks) where all receive ATH-063.
  • Participation requires attending visits up to Week 36, with some follow-ups via phone calls.
Eligibility: To join, participants must be 18-75 years old, have a confirmed UC diagnosis, and have tried other treatments that didn't work. They must also agree to use birth control if needed and have certain blood test results. Exclusions include recent severe UC flares, certain other health conditions, and use of specific medications. Participants must be able to understand and follow the study's procedures.
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Study details
    Ulcerative Colitis
    Inflammatory Bowel Diseases
    Autoimmune Diseases

NCT07513181

Athos Therapeutics Inc

17 October 2026

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