RecruitingPhase 2NCT07513181

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)

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)


Sponsor

Athos Therapeutics Inc

Enrollment

120 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic/advanced therapy relapsed/refractory moderately to severely active UC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ATH-063 and Placebo for people with autoimmune diseases, inflammatory bowel diseases, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGATH-063

Three 50 mg capsules, total dose 150 mg.

OTHERPlacebo

Identical capsule to the drug without the active ingredient.


Locations(4)

Miami Clinical Research

Miami, Florida, United States

GCP Clinical Research

Tampa, Florida, United States

Gastroenterology Consultants, P.C.

Roswell, Georgia, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07513181


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