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

Study acronym: PALEKONA
StatusActive, Not Recruiting
PhasePhase 2
Started2023-12-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Contacts/Locations v24
Enrollment closed, study ongoing
Trial sites reduced: 129 → 102 locations
2026-02-10
Study Status v23
Primary completion date2026-04→2027-01
Completion date2027-05→2028-02
2025-12-24
Study Status, Contacts/Locations v22
Study sites130→129
2025-11-27
Study Status, Contacts/Locations v21
Study sites130 entries, revised
Institute of Science Tokyo Medical And Dental University Hospital
2025-10-31
Study Status, Contacts/Locations v20
Study sites123→130
Show 19 earlier versions
2025-05-05
Study Status, Contacts/Locations v19
Study sites121→123
2025-02-28
Study Status, Contacts/Locations v18
Study sites114→121
2025-01-30
Study Status, Contacts/Locations v17
Study sites111→114
2024-12-24
Study Status, Contacts/Locations v16
Study sites110→111
2024-12-09
Study Status, Contacts/Locations v15
Study sites108→110
2024-11-21
Study Status v14
Re-verified, no change to tracked fields
2024-10-18
Study Status, Contacts/Locations v13
Study sites100→108
2024-09-10
Study Status, Contacts/Locations v12
Primary completion date2025-06→2026-04
Completion date2026-06→2027-05
Study sites95→100
2024-07-30
Study Status, Contacts/Locations v11
Study sites88→95
2024-06-26
Study Status, Eligibility, Contacts/Locations v10
Study sites65→88
Eligibility criteria-4 characters
[...] ore than 3 different advanced therapy mechanisms of action. Documentation of aA surveillance colonoscopy infor thedysplasia 24is monthsrequired prior to screeningrandomization inif indicated by regional guidelines for individuals who have a history ofwith UC for 8 or more years. Key Exclusion Criteria: Current diagnosis of Crohn's Disea [...]
2024-05-03
Study Status, Contacts/Locations v9
Study sites47→65
2024-04-09
Study Status, Contacts/Locations v8
Study sites36→47
2024-03-14
Study Status, Contacts/Locations v7
Study sites24→36
2024-02-16
Study Status, Contacts/Locations v6
Study sites11→24
2024-01-18
Study Status, Contacts/Locations v5
Study sites5→11
2023-12-19
Study Status, Contacts/Locations v4
Start dateestimated 2023-12→confirmed 2023-12-05
Study sites2→5
2023-11-30
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2023-11→2023-12
Study sites0→2
2023-10-25
Study Status v2
Start date2023-10→2023-11
2023-10-10
Study Status, Outcome Measures, References v1
Secondary endpoints5 entries, revised
Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 12
Primary endpoints1 entry, revised
Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score (MCS) at Week 12
2023-09-01
Original filing
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.
Trial Details
NCT Number NCT06029972
Lead Sponsor Gilead Sciences
Conditions Ulcerative Colitis
Enrollment 176 participants
Start Date 2023-12-05
Primary Completion 2027-01 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-11