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

Ulcerative Colitis Clinical Trial

— PALEKONA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029972
• Other study ID #: GS-US-457-6411
• Secondary ID: 2022-501119-14jR
• Status: Recruiting
• Phase: Phase 2
• Start date: December 5, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 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.

• Documentation of a surveillance colonoscopy in the 24 months prior to screening in individuals who have a history of UC for 8 or more years.

Key Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Tilpisertib Fosmecarbil
Tablets administered orally
• Placebo
Tablets administered orally

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Queen Elizabeth Hospital	Woodville	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology	Vienna
Canada	London Health Sciences Centre-University Hospital	London
Canada	Physician's Clinical Research, Inc. (PCRI)	Toronto
Canada	TDDA Speciality Research	Vaughan
France	Hopital Saint Eloi	Montpellier
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Hopital Rangueil	Toulouse
Germany	Eugastro Gmbh	Liepzig
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest
Italy	IRCCS Istituto Clinico Humanitas	Milano
Italy	Istituto Clinico Humanitas	Rozzano
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku
Japan	The Jikei University Hospital	Minato-ku
Japan	Kyorin University Hospital	Mitaka-shi
Japan	Ishida Clinic of IBD and Gastroenterology	Oita-shi
Japan	Saga University Hospital	Sagaken
Japan	Sapporo Medical University Hospital	Sapporo
Korea, Republic of	Inje University	Busan
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Yonsei University Severance Hospital	Seodaemun-Gu	VIC
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Poland	Specjalistyczna Praktyka Lekarska Leszek Bryniarski	Sopot
Switzerland	Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum	Bern
United Kingdom	Fairfield General Hospital	Bury
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Norfolk and Norwich University Hospital Nhs Foundation Trust	Norwich
United Kingdom	University Hospital Southampton Nhs Foundation Trust	Southampton
United States	Hill Country Digestive Health	Boerne	Texas
United States	Ellipsis Research Group	Brooklyn	New York
United States	GastroSb Weight Loss Clinic	Chula Vista	California
United States	Ohio Gastroenterology & Liver Institute	Cincinnati	Ohio
United States	Southern California Research Centers	Coronado	California
United States	Atlanta Center For Gastroenterology P.C.	Decatur	Georgia
United States	Gastroenterology Research of America	El Paso	Texas
United States	VVCRD Research	Garden Grove	California
United States	DHAT Research Institute	Garland	Texas
United States	Encore Medical Research, LLC	Hollywood	Florida
United States	Southwest Clinical Trials	Houston	Texas
United States	Gastro Care Institute	Lancaster	California
United States	Om Research LLC	Lancaster	California
United States	Florida Research Institute	Largo	Florida
United States	Lubbock Digestive Disease Associates	Lubbock	Texas
United States	GI Associates and Endoscopy Center - GI Alliance	Mansfield	Texas
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Wellness Research Center	Miami	Florida
United States	United Medical Doctors	Murrieta	California
United States	GI PROS Research	Naples	Florida
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Revival Clinical Research	Orlando	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Charles Clinical Research	Saint Louis	Missouri
United States	Clinical Associates in Research Therapeutics of America	San Antonio	Texas
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Arizona Digestive Health	Sun City	Arizona
United States	Gastroenterology Associates of Florida - GI Alliance	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Poland,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12
Secondary	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days
Secondary	Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities		First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days

External Links

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