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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)

NCT07513181 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ATH-063

Three 50 mg capsules, total dose 150 mg.

OTHER

Placebo

Identical capsule to the drug without the active ingredient.

Sponsors & Collaborators

  • Athos Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • David T. Rubin, MD · University of Chicago Biological Sciences Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-14
Completion
2028-12-14
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07513181 on ClinicalTrials.gov