← Back to Search

Other

Tilpisertib for Ulcerative Colitis (PALEKONA Trial)

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 screening visit.

Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose date up to week 52 (responders) or week 64 (non-responders) plus 30 days

Awards & highlights

PALEKONA Trial Summary

This trial will study the effectiveness and safety of a potential medication for ulcerative colitis. Participants will be randomly given the drug or a placebo.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

PALEKONA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man, or a woman not pregnant or breastfeeding, aged 18-75.

Select...

My ulcerative colitis is moderate to severe, based on a specific scoring system.

Select...

I have had ulcerative colitis for at least 3 months, confirmed by tests, affecting at least 15 cm from the anal verge.

PALEKONA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date up to week 52 (responders) or week 64 (non-responders) plus 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date up to week 52 (responders) or week 64 (non-responders) plus 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date up to week 52 (responders) or week 64 (non-responders) plus 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12

Secondary outcome measures

Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score at Week 12

+2 more

PALEKONA Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Tilpisertib Fosmecarbil Dose CExperimental Treatment1 Intervention

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose C for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Group II: Tilpisertib Fosmecarbil Dose BExperimental Treatment1 Intervention

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose B for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Group III: Tilpisertib Fosmecarbil Dose AExperimental Treatment1 Intervention

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose A for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.

Group IV: Tilpisertib Fosmecarbil PlaceboPlacebo Group2 Interventions

Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil placebo for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved Clinical Response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve Clinical Response at Non-responder Treatment Phase Week 12 will discontinue study drug.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,086 Total Patients Enrolled

7 Trials studying Ulcerative Colitis

3,233 Patients Enrolled for Ulcerative Colitis

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,517 Total Patients Enrolled

6 Trials studying Ulcerative Colitis

3,205 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots for enrolment in this experiment?

"Confirmed - this medical trial is actively recruiting patients according to the information on clinicaltrials.gov. It was first listed on December 1st 2023 and underwent its most recent update approximately one month later, at November 30th 2023."

Answered by AI

To what demographic is this clinical experiment open?

"This trial is seeking 176 participants aged 18 to 75 with a confirmed diagnosis of ulcerative colitis. Individuals assigned male at birth, or nonpregnant and nonlactating individuals assigned female at birth may participate. To qualify for the study patients must have moderately to severely active UC as determined by modified Mayo Clinic Score, failed prior treatments comprised of up to 3 advanced therapy mechanisms of action, and completed recent surveillance colonoscopy within 24 months before screening (for those who have had UC for 8+ years)."

Answered by AI

Does the enrollment criteria for this clinical trial permit individuals older than 20 years?

"The cutoff for applicants in this medical trial is 75 years old, and those under 18 cannot enroll. Additionally, there are 78 studies for minor-aged patients and 357 trials available to those aged above 65."

Answered by AI

What safety considerations should be taken into account when administering Tilpisertib Fosmecarbil Dose C to patients?

"The safety of Tilpisertib Fosmecarbil Dose C was graded as a 2 on our risk assessment scale due to the lack of efficacy data from Phase 2 trials."

Answered by AI

What is the uppermost capacity of participants in this trial?

"Affirmative, clinicaltrials.gov has proof that this medical trial is welcoming participants. Initially posted on December 1st 2023 and most recently edited November 30th 2023, it requires 176 individuals to be recruited from two locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

2023. "Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06029972.