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Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
 
Region Sponsors
California - Northern
Gilead Sciences
 
Acronym KP IRB No.
DIVERSITYL 1400454
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Crohn's Disease and must have enrolled in a Gilead-sponsored CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895
 
Purpose
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 Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).
 
Detailed Description
Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests. Time Frame: Up to 144 weeks plus 30 days.
 
Gender Age Limit
Male & Female
 
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 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
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol, for the duration described
  • 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
 
Exclusion Criteria
  • 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
  • Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the study protocol
  • Use of prohibited medications as outlined in the study protocol
  • Please contact study team for more eligibility criteria.

 
Keywords and/or Specific Medical Conditions
  • Digestive System Diseases
  • Inflammatory Bowel Diseases
  • Gastroenteritisastroenterology
  • Intestinal Diseases
  • Gastrointestinal Diseases
  • Crohn Disease
 
KP Clinical Facility
  • South San Francisco Medical Center
 
Clinical Area
  • Gastroenterology


Principal Investigator:
Fernando S Velayos, MD
Contact Information:
- Gastroenterology KPNC
-415-833-3485
-Catherine.Vowels@kp.org
-San Francisco Medical Center


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