A Phase 2b, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Clinical Study to Evaluate the Efficacy and Safety of ATH-063 Induction Therapy in Patients with Biologic Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)
Name: Placebo (microcrystalline cellulose) matching ATH-063 capsules
Dose: Three capsules QD dispensed monthly (Day 1Week 4and Week 8) in 30-count bottles
Mode of administration: administered orallyATH-063
Eligibility
Age group
18-64 years
Sex
Female, Male
Primary endpoint
• Clinical remission (UCDSS) at Week 12
Endpoint detail
1.Assessment of AEs, SAEs, and TEAEs leading to study discontinuation, 2.changes from baseline in clinical laboratory assessments, 3.changes from baseline in 12 lead ECG, physical examination, and vital signs assessments; and changes in concomitant medications at all study visits
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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