Overview

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

Status:
Active, not recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Collaborator:
Galapagos NV
Criteria
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

- Must have completed all required procedures or met protocol specified efficacy
discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC

- Females of childbearing potential must have a negative pregnancy test at Day 1

- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol specified method(s) of contraception as
described in the protocol 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

- Males or females of reproductive potential who are unwilling to abide by
protocol-specified contraceptive methods as defined in the participants

- Use of prohibited medications as outlined in the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.