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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 : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Noninfectious Uveitis Drug: Filgotinib Drug: Placebo to match filgotinib Drug: Prednisone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
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.

Drug: Filgotinib
200 mg tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Prednisone
Tablet(s) administered orally once daily

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.

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: Prednisone
Tablet(s) administered orally once daily




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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)

  7. Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Baseline to Week 52 ]


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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:

  • 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.


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): NCT03207815


Contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

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Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03207815     History of Changes
Other Study ID Numbers: GS-US-432-4097
2017-001485-17 ( EudraCT Number )
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents