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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06290934




Registration number
NCT06290934
Ethics application status
Date submitted
16/02/2024
Date registered
4/03/2024
Date last updated
18/10/2024

Titles & IDs
Public title
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) Part 1: Placebo-Controlled, Dose-Ranging Study of GS-1427; Part 2: Active-Controlled, Combination Study Evaluating the Efficacy and Safety of GS-1427 in Combination With Ustekinumab Versus GS-1427 or Ustekinumab Monotherapy
Secondary ID [1] 0 0
2023-508304-38
Secondary ID [2] 0 0
GS-US-409-5704
Universal Trial Number (UTN)
Trial acronym
SWIFT
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 - GS-1427
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Placebo-to-match GS-1427

Experimental: Part 1A, Part 1B: GS-1427 Dose A - Participants will receive GS-1427 Dose A Day 1 through Week 12 (Part 1A). Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part 1B).

Experimental: Part 1A, Part 1B: GS-1427 Dose B - Participants will receive GS-1427 Dose B Day 1 through Week 12 (Part 1A). Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part 1B).

Experimental: Part 1A, Part 1B: GS-1427 Dose C - Participants will receive GS-1427 Dose C Day 1 through Week 12 (Part 1A). Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part 1B).

Experimental: Part 1A, Placebo; Part 1B, GS-1427 - Participants will receive Placebo to match GS-1427 Day 1 through Week 12 (Part 1A). Participants will be eligible to be re-randomized to receive one of the GS-1427 dose A, B, or C treatment after Week 12 through Week 52 (Part 1B).

Experimental: Part 2: GS-1427 Monotherapy - Participants will receive GS-1427 (at a dose determined based in Part 1A) Day 1 through Week 12. Participants will be eligible to continue and remain on the same dose of GS-1427 through Week 24.

Experimental: Part 2: Ustekinumab Monotherapy - Participants will receive ustekinumab, initial dose determined by body weight: 260 to 520 mg intravenous (IV), then subsequent dose: 90 mg subcutaneous (SC) 8 weeks after the initial IV dose, and every 8 weeks up to week 16 ( total of 2 subcutaneous injections after initial IV ustekinumab). Participants will be eligible to continue and remain on the ustekinumab through Week 24.

Experimental: Part 2: GS-1427 + Ustekinumab Combination Therapy - Participants will receive GS-1427 (dose determined based on Part 1A) and ustekinumab, initial dose determined by body weight: 260 to 520 mg IV, then subsequent dose: 90 mg SC 8 weeks after the initial IV dose, and every 8 weeks up to week 16 ( total of 2 subcutaneous injections after initial IV ustekinumab). Participants will be eligible to continue and remain on the same dose of GS-1427 and ustekinumab combination therapy through Week 24.

Experimental: Part 2: Open-label GS-1427 - Participants who complete Part 2 Week 24, will be eligible to continue and and receive open-label GS-1427 through Week 52 at a dose to be determined in Part 1A.


Treatment: Drugs: GS-1427
Administered orally

Treatment: Drugs: Ustekinumab
Administered intravenously and subcutaneously

Treatment: Drugs: Placebo-to-match GS-1427
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Part 2: Proportion of Participants Achieving Clinical Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Parts 1 and 2: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths.
Timepoint [2] 0 0
First dose date up to 52 weeks plus 28 days
Secondary outcome [3] 0 0
Parts 1 and 2: Incidence of Treatment-emergent Lab Abnormalities
Timepoint [3] 0 0
First dose date up to 52 weeks plus 28 days
Secondary outcome [4] 0 0
Parts 1 and 2: Proportion of Participants Achieving Clinical Remission at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Part 1: Proportion of Participants Achieving Clinical Remission at Week 52
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Part 2: Proportion of Participants Achieving Clinical Remission at Week 24
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Part 2: Proportion of Participants Achieving Partial Modified Mayo Score Remission at Week 52
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Parts 1 and 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Part 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 24
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Parts 1 and 2: Proportion of Participants Achieving Mucosal Healing at Week 12
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Part 2: Proportion of Participants Achieving Mucosal Healing at Week 24
Timepoint [11] 0 0
Week 24
Secondary outcome [12] 0 0
Parts 1 and 2: Proportion of Participants Achieving Endoscopic Improvement at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Part 2: Proportion of Participants Achieving Endoscopic Improvement at Week 24
Timepoint [13] 0 0
Week 24

Eligibility
Key inclusion criteria
Key

* Individuals have Ulcerative Colitis (UC) of at least 90-days duration before randomization confirmed by endoscopy and histology at any time in the past. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
* Individuals have UC with minimum disease extent of 15 cm from the anal verge.
* Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
* Individuals have an inadequate response or loss of response or is intolerant to at least 1 of the following conventional UC treatments
* Individuals have an inadequate response or loss of response or are intolerant to:

* At least one of these conventional UC treatments: Corticosteroids, azathioprine or 6-mercaptopurine (6-MP)

OR

* No more than two advanced therapies: Tumor necrosis factor-alpha inhibitors, interleukin (IL)-12/23 inhibitors (Part 1 only; no prior use in Part 2), sphingosine 1-phosphate receptor modulators, and Janus kinase inhibitors

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis.
* Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
* Part 1 and 2; have any history of exposure to vedolizumab
* Part 2 only: have any history of exposure to interleukin - 12/23 or 23 inhibitor (eg ustekinumab)
* Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol

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
Other
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
27/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
423
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University - Sydney
Recruitment hospital [2] 0 0
Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Metro South Health - Woolloongabba
Recruitment hospital [4] 0 0
Monash Health - Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Northern Hospital - Northern Health - Epping
Recruitment hospital [6] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Footscray Hospital - Westerm Health - Footscray
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3076 - Epping
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
Vaughan
Country [16] 0 0
Georgia
State/province [16] 0 0
Tbilisi
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Busan
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Daegu
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Guri-Si
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Jongno-Gu
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Nam-Gu
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Wonju
Country [25] 0 0
Malaysia
State/province [25] 0 0
Kelantan
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kota Kinabalu
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kuantan
Country [28] 0 0
Malaysia
State/province [28] 0 0
Selangor
Country [29] 0 0
Moldova, Republic of
State/province [29] 0 0
Chisinau
Country [30] 0 0
Poland
State/province [30] 0 0
Kraków
Country [31] 0 0
Poland
State/province [31] 0 0
Mazowieckie
Country [32] 0 0
Poland
State/province [32] 0 0
Rzeszów
Country [33] 0 0
Poland
State/province [33] 0 0
Tychy
Country [34] 0 0
Poland
State/province [34] 0 0
Warsaw
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Taiwan
State/province [36] 0 0
Changhua City
Country [37] 0 0
Taiwan
State/province [37] 0 0
Kaohsiung
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taichung
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).

The primary objectives of this study are:

Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12

Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12
Trial website
https://clinicaltrials.gov/study/NCT06290934
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06290934