Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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 Crohn's disease (CD).

Official Title

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

Keywords

Crohn's Disease Crohn Disease Filgotinib Filgotinib Dose A (blinded dosing) Filgotinib Dose B (blinded dosing) Filgotinib Dose A (open-label) Filgotinib Dose B (open-label)

Eligibility

For people ages 18 years and up

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 met all eligibility criteria from a Gilead-sponsored CD parent protocol
  • 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.

Locations

  • University of California San Diego (UCSD)
    La Jolla California 92093 United States
  • Tibor Rubin VA Medical Center
    Corona California 92881 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02914600
Phase
Phase 3
Study Type
Interventional
Last Updated