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

MB

Matthew Bohm, DO

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years Gender: All Genders Phase: 3 1 Locations

Brief Description

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).

Detailed Description


Eligibility of study

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.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.