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



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 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


Crohn's Disease, Crohn Disease, Filgotinib, Filgotinib 200 mg (open-label), Filgotinib 100 mg (open-label)


You can join if…

Open to people ages 18 years and up

  • 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 CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
  • Females of childbearing potential must have a negative pregnancy test at Day 1
  • Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
  • 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 filgotinib treatment study for CD

You CAN'T join if...

  • 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
  • Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive 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.


  • UC San Diego Health Systems
    San Diego California 92093 United States
  • Southern California Research Center, Inc.
    Coronado California 92118 United States


accepting new patients by invitation only
Start Date
Completion Date
Galapagos NV
Phase 3 research study
Study Type
Expecting 1000 study participants
Last Updated