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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06029972




Registration number
NCT06029972
Ethics application status
Date submitted
1/09/2023
Date registered
8/09/2023

Titles & IDs
Public title
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
2022-501119-14
Secondary ID [2] 0 0
GS-US-457-6411
Universal Trial Number (UTN)
Trial acronym
PALEKONA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tilpisertib Fosmecarbil
Treatment: Drugs - Placebo

Experimental: Tilpisertib Fosmecarbil Dose A - 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.

Experimental: Tilpisertib Fosmecarbil Dose B - 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.

Experimental: Tilpisertib Fosmecarbil Dose C - 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.

Placebo comparator: Tilpisertib Fosmecarbil Placebo - 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.


Treatment: Drugs: Tilpisertib Fosmecarbil
Tablets administered orally

Treatment: Drugs: Placebo
Tablets administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of Participants Achieving Endoscopic Response at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of Participants Achieving Histologic Endoscopic Mucosal Improvement at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [4] 0 0
First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
Timepoint [5] 0 0
First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days

Eligibility
Key inclusion criteria
Key

* 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.

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
176
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
Northern Health - Epping
Recruitment hospital [7] 0 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3076 - Epping
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Austria
State/province [13] 0 0
St. Pölten
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
London
Country [17] 0 0
Canada
State/province [17] 0 0
Toronto
Country [18] 0 0
Canada
State/province [18] 0 0
Vaughan
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France
State/province [19] 0 0
Grenoble Cedex 9
Country [20] 0 0
France
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Lille
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France
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Montpellier
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France
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Nantes
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France
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Neuilly Sur Seine
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France
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Saint-Etienne
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France
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Toulouse
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Leipzig
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
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Hungary
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Szekszárd
Country [33] 0 0
Italy
State/province [33] 0 0
Catanzaro
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Italy
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Milano
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Italy
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Roma
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Italy
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Rozzano
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Japan
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Hyogo
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Japan
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Jonan-ku
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Japan
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Minato-ku
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Japan
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Mitaka-shi
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Japan
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Nagasaki
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Japan
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Oita-shi
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Japan
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Sagamihara
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Japan
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Saga
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Japan
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Sapporo
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Japan
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Tokyo
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Korea, Republic of
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VIC
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Junggu
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Rzeszów
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Poland
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Sopot
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Wroclaw
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Switzerland
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Bern
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United Kingdom
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Bury
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United Kingdom
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Cambridge
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United Kingdom
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London
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United Kingdom
State/province [64] 0 0
Norwich
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06029972