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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03207815
Ethics application status
Date submitted
30/06/2017
Date registered
5/07/2017

Titles & IDs
Public title
Study to Evaluate the 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 - Participants will receive filgotinib 200 milligrams (mg) once daily for up to 52 weeks along with a standardized prednisone burst of 60 milligrams per day (mg/day) at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.

Placebo comparator: Placebo - Participants will receive placebo to match filgotinib once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.


Treatment: Drugs: Filgotinib
Tablet(s) administered orally

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

Treatment: Drugs: Prednisone
Tablet(s) administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
Timepoint [1] 0 0
Week 6 through Week 24
Secondary outcome [1] 0 0
Time to Treatment Failure on or After Week 6
Timepoint [1] 0 0
Week 6 through Week 52
Secondary outcome [2] 0 0
Change in Vitreous Haze (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 or Early Termination (ET)
Timepoint [2] 0 0
Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
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 or ET
Timepoint [3] 0 0
Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
Secondary outcome [4] 0 0
Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
Timepoint [4] 0 0
Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
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 or ET
Timepoint [5] 0 0
Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)
Secondary outcome [6] 0 0
Time to Development of Macular Edema in At Least One Eye on or After Week 6
Timepoint [6] 0 0
Week 6 through Week 52
Secondary outcome [7] 0 0
Plasma Concentration of Filgotinib
Timepoint [7] 0 0
Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
Secondary outcome [8] 0 0
Plasma Concentration of Metabolite, GS-829845
Timepoint [8] 0 0
Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time

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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/04/2021
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Vancouver
Country [14] 0 0
Germany
State/province [14] 0 0
Münster
Country [15] 0 0
Israel
State/province [15] 0 0
Jerusalem
Country [16] 0 0
New Zealand
State/province [16] 0 0
Remuera
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Liverpool
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03207815