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Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease (DIVERSITYLTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02914600
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2016
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Filgotinib Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Only 3 arms are blinded in this study.
Primary Purpose: Treatment
Official Title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Filgotinib Dose A (blinded dosing)
Filgotinib dose A + placebo to match filgotinib dose B for up to 144 weeks
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo
Tablet(s) administered orally once daily
Experimental: Filgotinib Dose B (blinded dosing)
Filgotinib dose B + placebo to match filgotinib dose A for up to 144 weeks
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo
Tablet(s) administered orally once daily
Placebo Comparator: Placebo (blinded dosing)
Placebo for up to 144 weeks
 Drug: Placebo
Tablet(s) administered orally once daily
Experimental: Filgotinib Dose A (open-label)
Filgotinib dose A for up to 144 weeks
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib Dose B (open-label)
Filgotinib dose B for up to 144 weeks
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from Baseline in PRO2 Scores [ Time Frame: Baseline and up to 144 weeks ]
    PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.

  2. Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores [ Time Frame: Baseline and up to 144 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Key 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

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914600


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Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02914600     History of Changes
Other Study ID Numbers: GS-US-419-3896
2016-002763-34 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases