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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03207815




Registration number
NCT03207815
Ethics application status
Date submitted
30/06/2017
Date registered
5/07/2017
Date last updated
14/09/2020

Titles & IDs
Public title
Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
Scientific title
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
Secondary ID [1] 0 0
2017-001485-17
Secondary ID [2] 0 0
GS-US-432-4097
Universal Trial Number (UTN)
Trial acronym
Humboldt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Noninfectious Uveitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - Prednisone

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.

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.


Treatment: Drugs: Filgotinib
200 mg tablet(s) administered orally once daily

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

Treatment: Drugs: Prednisone
Tablet(s) administered orally once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by 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)
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Time to Treatment Failure on or After Week 6 - 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)
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Change in Anterior Chamber (AC) Cell Grade in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Log Change in Central Retinal Thickness in Each Eye, from Best State Achieved Prior to Week 6 to Week 52 or EOT Visit
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Time to Development of Macular Edema in At Least One Eye on or After Week 6 - Macular edema is determined by optical coherence tomography (OCT)
Timepoint [6] 0 0
Baseline to Week 52
Secondary outcome [7] 0 0
Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
Timepoint [7] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
Key

- 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) or untreated latent TB

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with elevated intraocular pressures and/or severe glaucoma

- 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)

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Save Sight Institute - Sydney
Recruitment hospital [2] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [3] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
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California
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Colorado
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Illinois
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Indiana
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Maryland
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Massachusetts
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Michigan
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New Jersey
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Texas
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Utah
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Washington
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Wisconsin
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Canada
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Montreal
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Canada
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Ottawa
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Canada
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Toronto
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Canada
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Vancouver
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Germany
State/province [21] 0 0
Münster
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Germany
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Tubingen
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv-Yafo
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New Zealand
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Remuera
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Singapore
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Singapore
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United Kingdom
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Aberdeen
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Belfast
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Bristol
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Liverpool
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London
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Manchester
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Oxford
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United Kingdom
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03207815
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03207815