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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 December 2023 |
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Main ID: |
NCT02914535 |
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Date of registration:
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22/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
SELECTIONLTE |
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Scientific title:
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A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis |
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Date of first enrolment:
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February 23, 2017 |
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Target sample size:
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1173 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02914535 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Czechia
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France
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Georgia
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Germany
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Greece
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Hong Kong
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Hungary
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Iceland
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India
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Malaysia
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Mexico
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Netherlands
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New Zealand
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Singapore
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Galapagos Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Galapagos NV |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Must have the ability to understand and sign a written informed consent form (ICF),
which must be obtained prior to initiation of study procedures associated with this
trial
- Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other
Gilead/Galapagos-sponsored filgotinib treatment study for UC
- Must have completed all required procedures or met protocol-specified efficacy
discontinuation criteria in a prior filgotinib treatment study for UC
- Females of childbearing potential must have a negative pregnancy test at Day 1
- Female individuals of childbearing potential who engage in heterosexual intercourse
must agree to use protocol specified method(s) of contraception for the duration
described
- Willingness to refrain from live or attenuated vaccines during the study and for 12
weeks after last dose of study drug
Key Exclusion Criteria:
- Known hypersensitivity to the study drug
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary
disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor,
would make the subject unsuitable for the study or would prevent compliance with the
study protocol
- Females of reproductive potential who are unwilling to abide by protocol-specified
contraceptive methods as defined
- Use of prohibited medications as outlined in the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Filgotinib
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Drug: Placebo
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Primary Outcome(s)
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Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
[Time Frame: Up to 336 weeks plus 30 days]
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Secondary Outcome(s)
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Change From Baseline in Components of Mayo Clinic Score (MCS)
[Time Frame: Baseline and up to 336 weeks]
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Secondary ID(s)
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2016-002765-58
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GS-US-418-3899
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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