AzTrials
AzTrials

Ulcerative ColitisPhase 2PALEKONANCT06029972

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

A Phase 2 study testing Tilpisertib Fosmecarbil in people with Ulcerative Colitis, run by Gilead Sciences at 102 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Tilpisertib Fosmecarbil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
102 sitesin 14 countries
Study dates
5 Dec 2023to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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 disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
  • 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).
  • Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action.
  • A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC.

Who cannot join

  • 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 randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.
  • History of opportunistic infection.
  • Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.
  • Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

102 sites in 14 countries.

102 sites in 14 countries

United States35 sites

  • Gastroenterology Research of Hill Country

    Boerne, Texas, 78006

  • Gastroenterology & Hepatology Specialists Inc

    Canton, Ohio, 44718

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • GastroSb Weight Loss Clinic

    Chula Vista, California, 91910

  • The Ohio State University Wexner Medical Centre

    Columbus, Ohio, 43210

  • Luna Research

    Coral Gables, Florida, 33134

  • Southern California Research Centers

    Coronado, California, 92118

  • University of Florida

    Gainesville, Florida, 32610

  • VVCRD Research

    Garden Grove, California, 92845

  • Corewell Health

    Grand Rapids, Michigan, 49546

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • The Medici Medical Research

    Hollywood, Florida, 33021

  • Skyline Gastroenterology of West Tennessee

    Jackson, Tennessee, 38301

  • Clinical Research of Osceola

    Kissimmee, Florida, 34741

  • UC San Diego Health System

    La Jolla, California, 92037

  • Gastro Care Institute

    Lancaster, California, 93534

  • Om Research LLC

    Lancaster, California, 93534

  • Emeritas Group Research

    Lansdowne Town Center, Virginia, 20176

  • Florida Research Institute

    Largo, Florida, 33771

  • GI Alliance

    Lubbock, Texas, 79410

  • GI PROS Research

    Naples, Florida, 34102

  • Clinical One Research

    Orlando, Florida, 32807

  • Digestive and Liver Center of Florida, LLC

    Orlando, Florida, 32825

  • Gastroenterology Associates of North Mississippi

    Oxford, Mississippi, 38655

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, Davis

    Sacramento, California, 95817

  • Clinical Associates in Research Therapeutics of America

    San Antonio, Texas, 78212

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94115

  • St. Charles Clinical Research

    St Louis, Missouri, 63141

  • GI Alliance

    Sun City, Arizona, 85351

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

Other trials in United States

Japan12 sites

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • Fukuoka University Hospital

    Jonan-ku, 814-0180

  • The Jikei University Hospital

    Minatoku, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

  • Kyorin University Hospital

    Mitaka-shi, 181-8611

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870-0823

  • Saga University Hospital

    Sagaken, 849-8501

  • Kitasato University Hospital

    Sagamihara, 252-0375

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

  • Ginza Central Clinic

    Tokyo, 104-0061

  • Institute of Science Tokyo Hospital

    Toukiyouto, 113-8519

Other trials in Japan

France8 sites

  • Centre Hospitalier Universitaire Grenoble

    Grenoble, 38043

  • Hôpital Claude Huriez

    Little Cedex, 59037

  • Hopital Saint Eloi

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000

  • Institut des MICI

    Neuilly-sur-Seine, 92200

  • CHU de Saint Etienne - Hopital Nord

    Saint-Etienne, 42055

  • Hopital Rangueil

    Toulouse, 31059

  • CHRU Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Poland8 sites

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • Medrise Sp. z o.o. Centrum Badań Klinicznych

    Lublin, 20-852

  • SOLUMED Centrum Medyczne

    Poznan, 60-425

  • Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie

    Rzeszów, 35-210

  • Specjalistyczna Praktyka Lekarska Leszek Bryniarski

    Sopot, 81-756

  • Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Specjalistyczne Gabinety Lekarskie Body Clinic

    Warsaw, 03-712

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Northern Health

    Epping, Victoria, 3076

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea7 sites

  • Inje University

    Busan, 48108

  • Yeungnam University Hospital

    Daegu, 42415

  • Kyungpook National University Hospital

    Junggu, 41944

  • Yonsei University Severance Hospital

    Seodaemun-Gu, VIC, 3772

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Hanyang University Hospital

    Seoul, 04763

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Germany5 sites

  • Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology

    Berlin, 13353

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Eugastro Gmbh

    Liepzig, 4103

  • Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz

    Ulm, 89081

Other trials in Germany

United Kingdom5 sites

  • Fairfield General Hospital

    Bury, BL9 7TD

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Barts Health NHS Trust

    London, E1 2AJ

  • Norfolk and Norwich University Hospital Nhs Foundation Trust

    Norwich, NR4 7UZ

  • University Hospital Southampton Nhs Foundation Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

Austria4 sites

  • Medical University of Innsbruck

    Innsbruck, 6020

  • University of Salzburg, Universitätsklinik für Innere Medizin III

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

    Vienna, 1090

Other trials in Austria

Italy4 sites

  • AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"

    Catanzaro, 88100

  • IRCCS Istituto Clinico Humanitas

    Milan, 20089

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Canada3 sites

  • London Health Sciences Centre-University Hospital

    London, N6A 5A5

  • Mount Sinai Hospital

    Toronto, MSG 1X5

  • TDDA Speciality Research

    Vaughan, L4L 4Y7

Other trials in Canada

Hungary2 sites

  • Tolna Megye Balassa Janos Korhaz

    Beri Balogh, 7100

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1033

Other trials in Hungary

Belgium1 site

  • Universitaire Ziekenhuis Leuven

    Leuven, 3000

Other trials in Belgium

Switzerland1 site

  • Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum

    Bern, 3012

Other trials in Switzerland

About this study

Official title: 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

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.

Being tested
Tilpisertib Fosmecarbil, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tilpisertib FosmecarbilDrug

    Also called GS-5290

    Tablets administered orally

  • PlaceboDrug

    Tablets administered orally

Study groups in NCT06029972
Study groupRoleWhat they receive
Tilpisertib Fosmecarbil Dose AExperimentalBlinded 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.
Receives: Drug: Tilpisertib Fosmecarbil
Tilpisertib Fosmecarbil Dose BExperimentalBlinded 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.
Receives: Drug: Tilpisertib Fosmecarbil
Tilpisertib Fosmecarbil Dose CExperimentalBlinded 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.
Receives: Drug: Tilpisertib Fosmecarbil
Tilpisertib Fosmecarbil PlaceboPlacebo comparatorBlinded 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.
Receives: Drug: Tilpisertib Fosmecarbil; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

    Measured: Week 12

Secondary outcomes (5)

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

    Clinical Remission is defined as a Stool Frequency subscore ≤ 1 and not greater than baseline, Rectal Bleeding subscore of 0, and Endoscopic Findings subscore ≤ 1 at Week 12. The modified Mayo Clinic Score is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

    Measured: Week 12

  2. Proportion of Participants Achieving Endoscopic Response at Week 12

    Endoscopic Response is defined as an Endoscopic Findings subscore ≤ 1 at Week 12. Endoscopic subscore is a part of the modified Mayo Clinic Score which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Higher scores indicate higher disease activity.

    Measured: Week 12

  3. Proportion of Participants Achieving Histologic Endoscopic Mucosal Improvement at Week 12

    Histologic Endoscopic Mucosal Improvement is defined as an Endoscopic Findings subscore ≤ 1 and Geboes score ≤ 3.1 (indicating neutrophil infiltration in < 5% of crypts, no crypt destruction and no erosions, ulcerations, or granulation tissue). Endoscopic subscore is a part of the modified Mayo Clinic Score which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Geboes histologic remission is assessed using the Geboes histologic scores to identify histologic changes in ulcerative colitis. Possible scores are graded as Grade 0 to Grade 5, with higher grade representing higher levels of disease activity.

    Measured: Week 12

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

    Measured: First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days

  5. Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

    Measured: First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start5 Dec 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029972
Sponsor's protocol ID
GS-US-457-6411
Other IDs
2022-501119-14, jRCT2031230403
Acronym
PALEKONA
Status last verified
Sep 2026
First submitted
1 Sep 2023
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Madia PA, Wendt ER, Qin AR, Qi X, Liang Y, Kalariya S, Hong F, Canales E, Taylor JG, Arulmani U, Kakkar T. First-In-Human Evaluation of the Pharmacokinetics, Pharmacodynamics, and Safety of Tilpisertib Fosmecarbil (GS-5290), an Oral Prodrug of a Tumor Progression Locus 2 Inhibitor in Healthy Participants. J Clin Pharmacol. 2026 Aug;66(8):e70269. doi: 10.1002/jcph.70269.

    PubMed 42634341

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tilpisertib Fosmecarbil in people with Ulcerative Colitis, run by Gilead Sciences at 102 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Japan, France, Poland, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in