Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lakefront Biotherapeutics NV
With
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
Female participants 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 may not be 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 concomitant medications as outlined in the study protocol
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