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)
Athos Therapeutics Inc
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.
Description
The trial will consist of a 4-week screening period, a 12-week double-blind treatment period, and an open-label extension. Following completion of the 12-week double-blind period, participants who wish to continue into the open-label extension will be unblinded. Participants who do not wish to continue into the extension will remain blinded and proceed to posttreatment follow-up at Weeks 16 and 24 (via telephone calls). Unblinded participants who are revealed to have been randomized to receive ATH-063 will also proceed to posttreatment follow-up at Weeks 16 and 24 (via telephone calls). Unbli…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions. * Male or female (assigned at birth, inclusive of all gender identities) participants 18 to 75 years of age, inclusive, at the time of informed consent. * Male or female participants must be postmenopausal/surgically sterile, sexually abstinent, or using 2 forms of protocol-specified contraception, including 1 physical barrier method (condom or diaphragm) plus 1 highly effective method (ie, hormonal contraception., intrauterine device, intrauterine ho…
Interventions
- DrugATH-063
Three 50 mg capsules, total dose 150 mg.
- OtherPlacebo
Identical capsule to the drug without the active ingredient.
Locations (2)
- Miami Clinical ResearchMiami, Florida
- Gastroenterology Consultants, P.C.Roswell, Georgia