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New treatment option for Ulcerative Colitis
Official title Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT06029972
What this study is testing
What is Tilpisertib Fosmecarbil?
Tilpisertib Fosmecarbil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
Also referred to as GS-5290.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the...
- Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum...
- Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal...
- Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack...
- A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC. Key
You likely can't join if
- Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
- Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
- Requirement for ongoing therapy with or prior use of any prohibited medications.
- Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks. of...
- History of opportunistic infection.
- Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Sun City, Arizona, United States
- Chula Vista, California, United States
- Coronado, California, United States
- Garden Grove, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Murrieta, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Valencia, California, United States
- Coral Gables, Florida, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- Kissimmee, Florida, United States
- Largo, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Wellington, Florida, United States
+ 96 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sun City, Arizona, United States; Chula Vista, California, United States; Coronado, California, United States; Garden Grove, California, United States; La Jolla, California, United States; Lancaster, California, United States and 110 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.