A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis
To demonstrate the effectiveness of the investigational drug GS-5290, compared to placebo control, in achieving Clinical Response at Week 12
Phase of study
Phase 2
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Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
Ulcerative Colitis
Severity
Moderate
Severe
Eligibility Criteria
Inclusion criteria:
Adults 18 to 75 years of age assigned male at birth, or nonpregnant, nonlactating patients assigned female at birth.
Patients must have a confirmed Ulcerative Colitis (UC) diagnosis at least 90 days prior to enrolling in the study.
Patients also must have UC with minimum disease extent of 15 cm from the anal verge.
Patients have moderately to severely active UC as determined during the screening visit and based on the studies scoring criteria.
Patients have prior treatment with at least one approved advanced therapy for ulcerative colitis (UC), but the patient must have experienced failure (such as no response or losing response) to no more than three different types of advanced therapies. A surveillance colonoscopy for dysplasia is required prior to enrollment if indicated by regional guidelines for patients with UC.
Exclusion criteria:
Have a current diagnosis of Crohn's Disease (CD) or a type of colitis that could not be clearly identified, such as one caused by an infection, or specific forms like lymphocytic or collagenous colitis
Patients with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
Have a requirement for ongoing therapy with or prior use of any prohibited medications.
Have an active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks of enrollment; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.
Have a history of opportunistic infection.
Have a current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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Study Details:
The goal of this study is to learn if the investigational drug tilpisertib fosmecarbil (GS-5290) is effective and safe intreating patients with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups and eligible patients can expect to participate in this study for 52 weeks.
Description of treatment or intervention
GS-5290 is an experimental drug that is currently not approved for the treatment of any medical condition. GS-5290 is being tested for the treatment of inflammatory bowel disease.
Possible risks and side effects:
Side effects of GS-5290 dosing include: dizziness, nausea, or change in taste. The most common laboratory abnormalities were mild to moderate elevations in creatinine (a waste product from the use of your muscles) and bilirubin (a normal waste product of aging red blood cells), but the affected participants had no related symptoms. The level of creatinine and bilirubin returned to baseline after GS-5290 was stopped.
Progress to date
Three Phase 1 studies in healthy volunteers provided information to support proceeding with this phase 2 study in UC patients. Certain drug-drug interactions were identified in the phase 1 studies, and study participants will therefore be carefully selected by excluding those who are on long term therapy with prohibited medications.
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Contact Information:
Site Locations
Erik H. Alayo M.D. Gastro SB587 3rd Ave
Chula Vista,
California 91910