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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 : October 10, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE September 22, 2016
First Posted Date  ICMJE September 26, 2016
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE March 17, 2017
Estimated Primary Completion Date February 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Overall Safety Profile of Filgotinib Evaluated by the Percentage of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests [ Time Frame: Up to 432 weeks plus 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
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 ]
Change History Complete list of historical versions of study NCT02914600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • Change from Baseline in PRO2 Scores [ Time Frame: Baseline and up to 432 weeks ]
    PRO2 are patient reported outcomes consisting of 2 items: abdominal pain severity and liquid stool frequency.
  • Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores [ Time Frame: Baseline and up to 432 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • 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.
  • Change from Baseline in Crohn's Disease Activity Index (CDAI) Scores [ Time Frame: Baseline and up to 144 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Official Title  ICMJE A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Only 3 arms are blinded in this study.
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo
    Tablet(s) administered orally once daily
Study Arms  ICMJE
  • Experimental: Filgotinib Dose A (blinded dosing)
    Filgotinib dose A + placebo to match filgotinib dose B for up to 432 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo
  • Experimental: Filgotinib Dose B (blinded dosing)
    Filgotinib dose B + placebo to match filgotinib dose A for up to 432 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo
  • Placebo Comparator: Placebo (blinded dosing)
    Placebo for up to 432 weeks
    Intervention: Drug: Placebo
  • Experimental: Filgotinib Dose A (open-label)
    Filgotinib dose A for up to 432 weeks
    Intervention: Drug: Filgotinib
  • Experimental: Filgotinib Dose B (open-label)
    Filgotinib dose B for up to 432 weeks
    Intervention: Drug: Filgotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 22, 2016)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2030
Estimated Primary Completion Date February 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Croatia,   Czechia,   France,   Georgia,   Germany,   Greece,   Hong Kong,   Hungary,   Iceland,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02914600
Other Study ID Numbers  ICMJE GS-US-419-3896
2016-002763-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP