176 Participants Needed

Tilpisertib for Ulcerative Colitis

(PALEKONA Trial)

Recruiting at 124 trial locations
GC
Overseen ByGilead Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Gilead Sciences
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that ongoing therapy with prohibited medications is not allowed. It's best to discuss your current medications with the trial team to see if they are allowed.

Who Is on the Research Team?

GS

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with moderate to severe ulcerative colitis confirmed by endoscopy. Participants must have tried at least one advanced UC therapy without success, but not more than three. They should have had a colonoscopy in the last two years if they've had UC for over eight years.

Inclusion Criteria

My ulcerative colitis is moderate to severe, based on a specific scoring system.
I have had ulcerative colitis for at least 3 months, confirmed by tests, affecting at least 15 cm from the anal verge.
You have been diagnosed with Ulcerative Colitis for at least 8 years and must possess evidence of a colonoscopy conducted within the past two years in order to be eligible.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Treatment

Participants receive tilpisertib fosmecarbil or placebo for up to 12 weeks. Efficacy assessment at Week 12.

12 weeks

Non-responder Treatment

Participants not achieving clinical response at Week 12 receive tilpisertib fosmecarbil Dose A for another 12 weeks. Efficacy assessment at Week 12 of this phase.

12 weeks

Extension

Participants achieving clinical response continue treatment with tilpisertib fosmecarbil for up to Week 52.

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tilpisertib Fosmecarbil
Trial Overview The study tests Tilpisertib Fosmecarbil's effectiveness and safety against a placebo in treating ulcerative colitis. The main goal is to see if patients show clinical improvement after 12 weeks of treatment compared to those taking the placebo.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Tilpisertib Fosmecarbil Dose CExperimental Treatment1 Intervention
Group II: Tilpisertib Fosmecarbil Dose BExperimental Treatment1 Intervention
Group III: Tilpisertib Fosmecarbil Dose AExperimental Treatment1 Intervention
Group IV: Tilpisertib Fosmecarbil PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

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