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Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (Humboldt)

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ClinicalTrials.gov Identifier: NCT03207815
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 5, 2017
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE July 26, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 [ Time Frame: Baseline to Week 24 ]
Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
  • New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
  • Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
  • Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Vitreous Haze (VH) grade (NEI/SUN Criteria)
  • Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
Proportion of Participants Failing Treatment for Active Non-Infectious Uveitis by Week 24 [ Time Frame: Baseline to Week 24 ]
Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
  • New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
  • Inability to achieve ≤ grade 0.5 (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
  • Inability to achieve ≤ grade 0.5 (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Vitreous Haze (VH) grade (NEI/SUN Criteria)
  • Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
Change History Complete list of historical versions of study NCT03207815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • Time to Treatment Failure on or After Week 6 [ Time Frame: Baseline to Week 52 ]
    Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
    • New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
    • Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
    • Inability to achieve ≤ grade 0.5+ (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in VH grade (NEI/SUN Criteria)
    • Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
  • Change in VH Grade in Each Eye (NEI/SUN criteria), from Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) visit [ Time Frame: Baseline to Week 52 ]
  • Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit [ Time Frame: Baseline to Week 52 ]
  • Change in Logarithm of the Minimal Angle of Resolution (logMAR) BCVA in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit [ Time Frame: Baseline to Week 52 ]
  • Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit [ Time Frame: Baseline to Week 52 ]
  • Time to Development of Macular Edema in At Least One Eye on or After Week 6 [ Time Frame: Baseline to Week 52 ]
    Macular edema is determined by optical coherence tomography (OCT)
  • Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Baseline to Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
  • Time to Treatment Failure on or After Week 6 [ Time Frame: Baseline to Week 52 ]
    Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
    • New active, inflammatory lesions relative to Day 1/Baseline (during all visits beginning Week 6 visit)
    • Inability to achieve ≤ grade 0.5 (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in Anterior Chamber Cell grade (SUN Criteria)
    • Inability to achieve ≤ grade 0.5 (at Week 6); or 2-step increase (all visits after Week 6) relative to best state achieved in VH grade (NEI/SUN Criteria)
    • Worsening of best corrected visual acuity (BCVA) by ≥ 15 letters relative to best state achieved (during all visits beginning at Week 6 visit)
  • Change in VH Grade in Each Eye (NEI/SUN criteria), from Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) visit [ Time Frame: Baseline to Week 52 ]
  • Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit [ Time Frame: Baseline to Week 52 ]
  • Change in Logarithm of the Minimal Angle of Resolution (logMAR) BCVA in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit [ Time Frame: Baseline to Week 52 ]
  • Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit [ Time Frame: Baseline to Week 52 ]
  • Time to Development of Macular Edema in At Least One Eye on or After Week 6 [ Time Frame: Baseline to Week 52 ]
    Macular edema is determined by optical coherence tomography (OCT)
  • Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Baseline to Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Official Title  ICMJE A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
Brief Summary The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis in participants failing treatment for active noninfectious uveitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Noninfectious Uveitis
Intervention  ICMJE
  • Drug: Filgotinib
    200 mg tablet(s) administered orally once daily
    Other Names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
  • Drug: Prednisone
    Tablet(s) administered orally once daily
Study Arms  ICMJE
  • Experimental: Filgotinib

    All participants will receive a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule, to Week 15.

    All participants will receive filgotinib for up to 52 weeks.

    Interventions:
    • Drug: Filgotinib
    • Drug: Prednisone
  • Placebo Comparator: Placebo

    All participants will receive a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule, to Week 15.

    All participants will receive placebo to match filgotinib for up to 52 weeks.

    Interventions:
    • Drug: Placebo to match filgotinib
    • Drug: Prednisone
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2017)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
  • Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:

    • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
    • ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria
    • ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria
  • No evidence of active tuberculosis (TB), history of prior TB or latent TB meeting the screening criteria

Key Exclusion Criteria:

  • Elevated intraocular pressures and/or severe glaucoma at screening
  • Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
  • Adults in whom anti-tumor necrosis factor (TNF) therapy has failed in controlling uveitis (as determined by the investigator) or previous exposure to any biologic therapy (except intravitreal anti-vascular endothelial growth factor (VEGF) therapy) with a potential therapeutic impact on noninfectious uveitis within 90 days of Day 1/ Baseline are not eligible to participate

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: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Israel,   New Zealand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03207815
Other Study ID Numbers  ICMJE GS-US-432-4097
2017-001485-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 Not Provided
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