Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease (DIVERSITYLTE)
M
Matthew Bohm, DO
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
3
1000 participants needed
1 Location
Brief description of study
The primary objective of this study is to observe the long-term safety of filgotinib indults who have completed or met protocol specified efficacy discontinuation criteria in agotinib treatment study in Crohn's disease (CD).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Crohn's Disease
-
Age: 18 Years
-
Gender: All
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
- Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 orGS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study forCD
- Females of childbearing potential must have a negative pregnancy test at Day 1
- Female subjects of childbearing potential who engage in heterosexual intercourse mustgree to use protocol specified method(s) of contraception for the duration describedhe protocol
- Willingness to refrain from live or attenuated vaccines during the study and for 12weeks after last dose of study drug
- Must have completed all required procedures or met protocol specified efficacydiscontinuation criteria in a prior filgotinib treatment study for CD
Key Exclusion Criteria:
- Known hypersensitivity to the study drug
- Any chronic medical condition (including, but not limited to, cardiac or pulmonarydisease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor,would make the individual unsuitable for the study or would prevent compliance withhe study protocol
- Females of reproductive potential who are unwilling to abide by protocol-specifiedve methods as defined in the protocol
- Use of prohibited medications as outlined in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Updated on
01 Aug 2024.
Study ID: GS-US-419-3896
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