Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Conditions
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 • 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 and must agree to continued monthly pregnancy testing during use of filgotinib treatment • Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 920 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • 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. • 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 subject unsuitable for the study or would prevent compliance with the study protocol • 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 • Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug • Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol • Use of prohibited concomitant medications as outlined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-Sponsored filgotinib treatment study in CD;Secondary Objective: To evaluate the effect of filgotinib on Patient Reported Outcomes (PRO2) and Crohn’s Disease Activity Index (CDAI) scores;Primary end point(s): Safety, evaluated through AEs, clinical laboratory tests, and vital signs;Timepoint(s) of evaluation of this end point: Week 432 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in PRO2 and CDAI scores;Timepoint(s) of evaluation of this end point: Week 432 | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Galapagos NV
Outcome results
None listed