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

Phase 3

Completed

• Conditions: Crohn’s Disease

• Registration Number: SLCTR/2019/002
• Lead Sponsor: Gilead Sciences, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1. Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
2. Must have met all eligibility criteria from trial SLCTR/2018/029.
3. Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
4. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 6 of the protocol for the duration described
5. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
6. Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for Crohn’s Disease - SLCTR/2018/029

Exclusion Criteria

1. Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study. Details of discontinuation are provided as an annexure.
2. Known hypersensitivity to the study drug
3. Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
4. Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 35 days of the last dose of the study drug
5. Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
6. Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in Appendix 6 of the protocol
7. Use of prohibited medications as outlined in Section 5.4 of the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified