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)

Part of paid clinical trials in Miami, Florida.

Sponsor
Athos Therapeutics Inc
Study ID
NCT07513181
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ATH-063 — DRUG
    Three 50 mg capsules, total dose 150 mg.
  • Placebo — OTHER
    Identical capsule to the drug without the active ingredient.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 14, 2028
Completion
Dec 14, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ATH-063 150 mg
    Participants will be randomized to receive ATH-063 150 mg orally QD for 12 weeks, with posttreatment follow-up at Weeks 16 and 24.
  • Placebo Comparator: Placebo
    Participants will be randomized to receive matching placebo orally QD for 12 weeks, with posttreatment follow-up at Weeks 16 and 24.

Primary Outcome Measure

Clinical Remission at Week 12 [ Time Frame: At Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIP
Miami Clinical ResearchMiamiFlorida33155
Gastroenterology Consultants, P.C.RoswellGeorgia30076

Find similar trials in Miami, FL

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Miami Clinical Research· Miami, FLGastroenterology Consultants, P.C.· Roswell, GA

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