Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

  • Interventional
  • Enrolling by invitation
  • NCT02914600
Eligibility Details Visit Clinicaltrials.gov

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

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 Crohn's disease (CD).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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 a Gilead-sponsored CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895

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

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

         - Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored 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 pulmonary disease, 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 with the study protocol

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

         - Use of prohibited medications as outlined in the study protocol

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

At a Glance

National Government IDNCT02914600

IRB#IRB19-0404

Lead SponsorGilead Sciences

Lead PhysicianDavid Rubin

Collaborator(s)N/A

EligibilityAll
18 Years and up
Enrolling by invitation