Clinical trial NCT03207815
Conditions: Noninfectious Uveitis
Sponsor: Gilead Sciences
Start date: 2017-07-26; Completion date: 2021-04-22
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.

Detailed description:

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Filgotinib intervention 2: Placebo to match filgotinib intervention 3: Prednisone
Intervention descriptions: intervention 1: Tablet(s) administered orally intervention 2: Tablet(s) administered orally intervention 3: Tablet(s) administered orally

Protocol documents:
Prot_000.pdf: 
Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
Indication: 
Protocol ID: 
PD 
PD 
Protocol 
Version/Date: 
(rJ GILEAU 
CLINICAL STUDY PROTOCOL 
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the 
Efficacy and Safety of Filgotinib in Subjects with Active 
Noninfectious Uveitis 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, CA 94404 
133054 
2017-001485-17 
NCT03207815 
Noninfectious Uveitis 
GS-US-432-4097 
Naine: 
Telephone: 
Email: 
Naine: 
Telephone: 
Email: 
Original: 
Amendment 1: 
Amendment 2: 
Amendment 3: 
Amendment 4: 
PD 
PD 
PD 
PD 
PD 
PD 
13 April 2017 
14 November 2017 
18 December 2017 
12 December 2019 
17 March 2020 
CONFIDENTIALITY STATEMENT 
The infonnation contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
Institutional Review Board or Independent Ethics Co1mnittee. The infonnation is only to be 
used by you in c01mection with authorized clinical studies of the investigational drug 
described in the protocol. You will not disclose any of the infonnation to others without 
written authorization from Gilead Sciences, Inc., except to the extent necessary to obtain 
infonned consent from those persons to whom the drug may be administered. 


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TABLE OF CONTENTS 
TABLE OF CONTENTS .............................................................................................................................................. 2 
LIST OF IN-TEXTTABLES ........................................................................................................................................ 5 
LIST OF IN-TEXT FIGURES ...................................................................................................................................... 5 
PROTOCOL SYNOPSIS .............................................................................................................................................. 6 
GLOSSARY OF ABBREVIATIONS AND DEFCNITION OF TERMS .................................................................... 16 
I. 
INTRODUCTION .............................................................................................................................................. 19 
1.1. 
Background ............................................................................................................................................ 19 
1.2. 
Filgotinib ................................................................................................................................................ 20 
1.2.1. 
General Information ............................................................................................................. 20 
1.2.2. 
Nonclinical Pharmacology and Toxicology ......................................................................... 20 
1.2.3. 
Clinical Trials of Filgotinib .................................................................................................. 23 
1.3. 
Rationale for This Study ........................................................................................................................ 23 
1.3. I. 
Rationale for Dose Selection ................................................................................................ 24 
1.4. 
Risk/Benefit Assessment for the Study .................................................................................................. 25 
1.5. 
Compliance ............................................................................................................................................ 26 
2. 
OBJECTIVES ..................................................................................................................................................... 27 
3. 
STUDY DESIGN ................................................................................................................................................ 29 
3.1. 
Endpoints ............................................................................................................................................... 29 
3.2. 
Study Design .......................................................................................................................................... 30 
3.3. 
Study Treatments ................................................................................................................................... 3 1 
3 .3. I. 
Dosage and Administration of Prednisone ........................................................................... 3 1 
3.4. 
Duration of Treatment ............................................................................................................................ 33 
3.5. 
Discontinuation Criteria ......................................................................................................................... 33 
3 .5.1. 
Study Dtug Interruption Considerations ............................................................................... 33 
3.5.2. 
Study Dtug Discontinuation Criteria .................................................................................... 33 
3.5.3. 
Stud Discontinuation Due to Treatment Failure ................................................................. 35 
4. 
SUBJECT POPULATION .................................................................................................................................. 39 
4.1. 
Number of Subjects and Subject Selection ............................................................................................ 39 
4.2. 
Inclusion Criteria .................................................................................................................................... 39 
4.3. 
Exclusion Criteria ................................................................................................................................... 4 1 
5. 
INVESTIGATIONAL MEDICINAL PRODUCTS ........................................................................................... 46 
5.1. 
Randomization, Masking and Treatment Codes .................................................................................... 46 
5.1.1. 
Masking ................................................................................................................................ 46 
5.1.2. 
Procedures for Breaking Treatment Codes ........................................................................... 46 
5.2. 
Description and Handling of Filgotinib and Placebo-to-Match Filgotinib ............................................. 47 
5.2.1. 
Formulation .......................................................................................................................... 47 
5.2.2. 
Packaging and Labeling ....................................................................................................... 47 
5.2.3. 
Storage and Handling ........................................................................................................... 47 
5.3. 
Dosage and Administration of Filgotinib ............................................................................................... 48 
5.4. 
Prior and Concomitant Medications ....................................................................................................... 48 
5.4.1. 
Allowed Concomitant Medications ...................................................................................... 50 
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5.4.2. 
Prohibited Concomitant Medications ................................................................................... 50 
5.5. 
Vaccine Guidelines ................................................................................................................................ 52 
5.6. 
Accountability for Study Drug ............................................................................................................... 53 
5.6.1. 
Study Dmg Return or Disposal ............................................................................................ 53 
6. 
STUDY PROCEDURES .................................................................................................................................... 54 
6.1. 
Subject Enrollment and Treatment Assignment ..................................................................................... 54 
6.2. 
Study Procedures Descriptions ............................................................................................................... 55 
6.2.1. 
Informed Consent ................................................................................................................. 55 
6.2.2. 
Medical History .................................................................................................................... 55 
6.2.3. 
Safety .................................................................................................................................... 55 
6.3. 
Disease Assessments .............................................................................................................................. 58 
6.3.5. 
V1sua 
p t a mo og1c E bcacy Assessments ..................................................................... 5 
6.3.6. 
Viral Monitoring: HCV and HBV ........................................................................................ 64 
6.4. 
Pharmacokinetics Assessments .............................................................................................................. 64 
" 
En o Treatment.................................................................................................................................... 4 
6.7. 
Unscheduled Visit Attributed to Uveitis Symptoms .............................................................................. 65 
6.8. 
End of Study ........................................................................................................................................... 65 
7. 
ADVERSE EVENTS AND TOXICITY MANAGEMENT ............................................................................... 66 
7. I. 
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events ................................. 66 
7. I. I. 
Adverse Events ..................................................................................................................... 66 
7 .1.2. 
Serious Adverse Events ........................................................................................................ 66 
7.2. 
Assessment of Adverse Events and Serious Adverse Events ................................................................. 67 
7 .2.1. 
Assessment of Causality for Study Drugs and Procedures ................................................... 67 
7 .2.2. 
Assessment of Severity ........................................................................................................ 68 
7.3. 
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead ....................................................................................................................... 68 
7.4. 
Gilead Reporting Requirements ............................................................................................................. 70 
7.5. 
Clinical Laboratory Abnormalities and Other Abnormal Assessments .................................................. 70 
7 .6. 
Toxicity Management ............................................................................................................................ 7 1 
7 .6.1. 
Grades I and 2 Laboratory Abnormality or Clinical Event... ............................................... 7 1 
7 .6.2. 
Grades 3 Laboratory Abnormality or Clinical Event ........................................................... 7 1 
7.6.3. 
Grades 4 Laboratory Abnormality or Clinical Event ........................................................... 72 
7.7. 
Special Situations Reports ...................................................................................................................... 72 
7.7.1. 
Definitions of Special Situations .......................................................................................... 72 
7.7.2. 
Instmctions for Reporting Special Situations ....................................................................... 73 
8. 
STA TIS TI CAL CONSIDERATIONS ................................................................................................................ 75 
8.1. 
8.2. 
8.3. 
8.4. 
Analysis Objectives and Endpoints ........................................................................................................ 75 
8.1.1. 
Analysis Objectives .............................................................................................................. 75 
8.1.2. 
Primary Endpoint ................................................................................................................. 76 
8.1.3. 
Secondar End oint ............................................................................................................. 76 
.
ysis Conventions ............................................................................................................................. 77 
8.2.1. 
Analysis Sets ........................................................................................................................ 77 
Data Handling Conventions ................................................................................................................... 78 
Demographic Data and Baseline Characteristics ................................................................................... 78 
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8.5.
Efficacy Analysis ...................................................................................................................................79
8.5.1.
Primary Analysis..................................................................................................................79
8.5.2.
Secondary Analyses .............................................................................................................79
8.6.
Safety Analysis.......................................................................................................................................81
8.6.1.
Extent of Exposure...............................................................................................................81
8.6.2.
Adverse Events.....................................................................................................................81
8.6.3.
Laboratory Evaluations ........................................................................................................82
8.7.
Pharmacokinetic Analysis......................................................................................................................82
8.9.
Sample Size............................................................................................................................................82
8.10.
Data Monitoring Committee (DMC)......................................................................................................83
8.11.
Ad Hoc DMC Meeting...........................................................................................................................83
8.12.
Cardiovascular Safety Endpoint Adjudication Committee (CVEAC) ...................................................84
9.
RESPONSIBILITIES..........................................................................................................................................85
9.1.
Investigator Responsibilities ..................................................................................................................85
9.1.1.
Good Clinical Practice..........................................................................................................85
9.1.2.
Financial Disclosure.............................................................................................................85
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval...............................................................................................................................85
9.1.4.
Informed Consent.................................................................................................................85
9.1.5.
Confidentiality......................................................................................................................86
9.1.6.
Study Files and Retention of Records ..................................................................................86
9.1.7.
Case Report Forms...............................................................................................................88
9.1.8.
Investigator Inspections........................................................................................................88
9.1.9.
Protocol Compliance............................................................................................................88
9.2.
Sponsor Responsibilities ........................................................................................................................89
9.2.1.
Protocol Modifications.........................................................................................................89
9.2.2.
Study Report and Publications .............................................................................................89
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................89
9.3.1.
Payment Reporting...............................................................................................................89
9.3.2.
Access to Information for Monitoring..................................................................................90
9.3.3.
Access to Information for Auditing or Inspections ..............................................................90
9.3.4.
Study Discontinuation..........................................................................................................90
10.
REFERENCES ...................................................................................................................................................91
11.
APPENDICES ....................................................................................................................................................93
Appendix 1.
Investigator Signature Page....................................................................................................94
Appendix 2.
Study Procedures Table..........................................................................................................95
Appendix 3.
Management of Clinical and Laboratory Adverse Events....................................................100
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.............101
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements.................................................................................................102
Appendix 6.
Clinical Laboratory Assessment Table.................................................................................106
Appendix 7.
Corticosteroid Conversion Table..........................................................................................107
Appendix 8.
AREDS 2008 Clinical Lens Opacity Grading Procedures ...................................................108
CCI
CCI


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LIST OF IN-TEXT TABLES
Table 3-1.
Prednisone Taper Schedule ....................................................................................................32
Table 3-2.
Topical Ocular Corticosteroid Taper Schedule ......................................................................32
Table 3-3.
Treatment Failure Criteria ......................................................................................................35
Table 5-1.
Prohibited Medications...........................................................................................................51
Table 6-1.
Anterior Chamber Cells..........................................................................................................60
Table 6-2.
Lens Opacity Grading.............................................................................................................61
Table 6-3.
Vitreous Haze Grading...........................................................................................................62
Table 7-1.
Grading of Adverse Event Severity........................................................................................68
LIST OF IN-TEXT FIGURES
Figure 3-1.
Study Schema.........................................................................................................................31


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: 
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the 
Efficacy and Safety of Filgotinib in Subjects with Active 
Noninfectious Uveitis
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
133054
2017-001485-17
NCT03207815
Study Centers 
Planned:
Approximately 75 centers globally
Objectives:
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 as 
measured by the proportion of subjects failing treatment for 
active noninfectious uveitis by Week 24
The secondary objectives of this study are: 

To evaluate the efficacy of filgotinib versus placebo for the 
treatment of noninfectious uveitis as measured by the time to 
treatment failure on or after Week 6 

To evaluate the efficacy of filgotinib versus placebo for the 
treatment of noninfectious uveitis as measured by the change in 
vitreous haze (VH) grade in each eye (National Eye Institute /
Standardization of Uveitis Nomenclature [NEI/SUN] criteria), 
from best state achieved prior to Week 6 to Week 52/ End of 
Treatment (EOT) visit or Early Termination (ET) visit 

To evaluate the efficacy of filgotinib versus placebo for the 
treatment of noninfectious uveitis as measured by the change in 
anterior chamber (AC) cell grade in each eye, from best state 
achieved prior to Week 6 to Week 52/ EOT visit or ET visit 

To evaluate the effects of filgotinib versus placebo as measured 
by the 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/EOT visit 
or ET visit


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• 
To evaluate the efficacy of filgotinib versus placebo for the 
treatment of noninfectious uveitis as measured by the change in 
central retinal thickness in each eye, from best state achieved 
prior to Week 6 to Week 52/ EOT visit or ET visit 
• 
To evaluate the efficacy of filgotinib versus placebo for the 
treatment of noninfectious uveitis as measured by the time to 
development of macular edema in at least one eye as detennined 
by optical coherence tomography (OCT) on or after Week 6 
• 
To evaluate the safety and tolerability of filgotinib 
• 
To evaluate the phannacokinetics of filgotinib and its metabolite 
GS-829845 
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Study Design:
This is a randomized, double-masked, placebo-controlled Phase 2 
trial in adult subjects with active noninfectious intermediate-, 
posterior-, or pan-uveitis in at least one eye despite at least 2 weeks 
of maintenance therapy with oral prednisone at a dose of ≥ 
10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent). 
The study is designed to demonstrate the efficacy and safety of 
filgotinib in adult subjects requiring high dose steroids for active 
noninfectious intermediate-, posterior-, or pan-uveitis. Both of the 
subject's eyes must be clinically evaluable for the purpose of 
determining eligibility based on inclusion and exclusion criteria, and 
for the purpose of assessing Treatment Failure. There will be no 
designated "study eye."
Subjects will be randomized in a 1:1 ratio to receive filgotinib 
200 mg once daily or placebo to match (PTM) for up to 52 weeks. 
Subjects that meet criteria for treatment failure or discontinue for 
any other reason prior to the end of the study will have an EOT or 
ET visit (as appropriate). Subjects that early terminate should also 
complete the 4-Week Post-Treatment Follow-Up Visit. 
It is anticipated that approximately twenty-five percent of subjects 
will have their uveitis attributed to sarcoidosis. Subjects will be 
stratified according to whether their uveitis is attributed to 
sarcoidosis (yes/no), baseline use of immunosuppressant(s) (yes/no), 
and prior use of anti-TNF therapy (yes/no). All subjects will be 
administered 60 mg/day of oral prednisone at Day 1/Baseline 
followed by a protocol-defined mandatory taper schedule in which
all subjects continuing in the study will discontinue prednisone no 
later than Week 15. Subjects who enter the study on topical ocular 
corticosteroids will undergo a standardized taper schedule until they 
have completely discontinued topical ocular corticosteroids no later 
than Week 9. Depending on the topical ocular corticosteroid dose 
that the subject is on at the baseline visit, the number of drops per 
day will be decreased every week according to a predefined schedule 
(Section 3.3.1).
Beginning at Week 6 and at all subsequent visits, subjects will be 
examined for evidence of treatment failure. Treatment failure will be 
defined as a subject meeting at least one of the elements of failure 
criteria in at least 1 eye as outlined in Table 3-3.
Subjects with evidence of treatment failure at or after Week 6 will be 
discontinued from study and treated at the discretion of the 
investigator.
Number of Subjects 
Planned:
Approximately 248 subjects


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Target Population:
Adult subjects 18 years or older with active, noninfectious 
intermediate-, posterior-, or pan-uveitis
Duration of 
Treatment:
Subjects will receive a maximum of 52 weeks of study drug in the 
randomized, double-masked trial
Diagnosis and Main 
Eligibility Criteria:
For a complete list of study inclusion and exclusion criteria, 
please refer to Section 4.
Main Eligibility Criteria
1) Male or female subjects who are ≥18 years of age, on the day of 
signing informed consent
2) Subject is diagnosed with noninfectious intermediate-, posterior-, 
or pan-uveitis
3) Subject 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 or more of 
maintenance therapy with oral prednisone (≥ 10 mg/day to 
≤60 mg/day) or oral corticosteroid equivalent:

Active, inflammatory, chorioretinal and/or inflammatory 
retinal vascular lesion

≥ 2+ anterior chamber cells (SUN criteria)

≥ 2+ vitreous haze (NEI/SUN criteria)
4) On oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral 
corticosteroid equivalent) for 2 or more weeks immediately prior 
to and including Day 1/Baseline 
5) No evidence of active tuberculosis (TB) or untreated latent TB
(Section 4.2)
6) Subjects with confirmed or suspected infectious uveitis or with 
clinically significant (as per the judgement of the investigator) 
active or chronic recurring infection, opportunistic infection, or 
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7) Subjects with elevated intraocular pressures and/or severe 
glaucoma must meet the following criteria within the screening 
period:

Intraocular pressure of < 25 mmHg in the absence of therapy 
or if on a single glaucoma medication 

Intraocular pressure of < 21 mmHg if on 2 or more glaucoma 
medications

Subject must have no evidence of glaucomatous optic nerve 
injury that involves or encroaches on central fixation, 
regardless of intraocular pressure or number of glaucoma 
medications

Subject must have no evidence of glaucomatous optic nerve 
injury that, in the opinion of the investigator, has the 
potential for splitting fixation or visual acuity loss during the 
course of the study, regardless of intraocular pressure or 
number of glaucoma medications
Study Procedures/
Frequency:
Participating subjects will visit the clinical study center at Screening, 
Day 1/Baseline, Weeks 1, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 
48, and 52/EOT or ET as applicable. If a subject presents at a site for 
an Unscheduled visit with symptoms related to a uveitis flare, 
subjects should be evaluated for treatment failure criteria in both 
eyes. If treatment failure criteria are met, investigators should 
complete EOT procedures. If a subject presents at a site for an 
Unscheduled visit not related to a uveitis flare, investigators should 
complete unscheduled visit procedures at their discretion.
All subjects will undergo a follow-up visit 4 weeks after the last 
dose of study drug (4-Week Post-Treatment Visit). Consequently, 
subjects are planned to be in the study (inclusive of screening and 
post study treatment follow-up) for up to 60 weeks.
Investigator confirmation of active uveitis in at least one eye 
(according to the inclusion criteria above) is required at Day 
1/Baseline. In addition, information on demographics, medical 
history/concomitant diseases, as well as both prior and current 
uveitis medication(s) will be collected at Screening and Day
1/Baseline. 
Screening assessments will include a complete physical exam (PE) 
(including height and weight), vital signs (ie, blood pressure, pulse 
rate, and temperature) and a standard 12-lead electrocardiogram 
(ECG). The ECG will be interpreted by the investigator (or qualified 
designee) for clinical significance. A chest x-ray is also required (if 
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screening). Additional screening laboratory assessments include the 
following:

Hepatitis B virus (HBV) test

Hepatitis C virus (HCV) test

Human immunodeficiency virus (HIV) antigen/antibody
combination test (4th generation) to HIV type 1 (HIV-1) and HIV
type 2 (HIV-2)

QuantiFERON® TB Gold in Tube Test

Syphilis test (either a FTA test or a syphilis IgG test)

Clinical laboratory tests (hematology, chemistry and urinalysis)

Urine drug tests

Serum pregnancy test for females with childbearing potential or
follicle stimulating hormone (FSH) test for females <54 years of
age and amenorrhea of ≥12 months, as defined in Appendix 5.
The required screening labs can be obtained either using the sites 
local lab or by submitting appropriate samples to the central lab. 
Laboratory tests performed for the purposes of standard medical care 
can be used to satisfy eligibility criteria as long as they are 
completed within the allowable screening period (or within the 
stated period otherwise outlined in Appendix 2). The required study 
laboratory assessments are outlined in Appendix 2 (Study 
Procedures Table) and Appendix 6 (Clinical Laboratory 
Assessment) in detail.
At Day 1/Baseline, after the subject’s eligibility for the study has 
been confirmed, the subject will be randomized into the study to 
receive filgotinib 200 mg daily or PTM. All subjects will receive a 
standardized prednisone dose of 60 mg/day at Day 1/Baseline 
followed by a protocol-defined mandatory taper schedule, as 
outlined in Section 3.3.1, in which all subjects continuing in the 
study will be off prednisone by Week 15. 
Subjects who enter the study on topical ocular corticosteroids will 
undergo a standardized taper schedule beginning at Day 1/Baseline. 
Subjects must be off topical ocular corticosteroids by Week 9. 
Depending on the dose that the subject is on at the Day 1/Baseline 
visit, the number of drops per day will be decreased every week at 
the increments indicated in Table 3-2.
Subjects will be able to continue certain oral uveitis control 
medications, provided the subject is taking only one of the allowable 
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medications (within the specified dose range) detailed in 
Section 5.4.1 (Allowed Concomitant Medications). 
Final 
Amendment4 
Study medication will be dispensed and subjects and/or their 
care-giver will be instructed on the dosing schedule. 
On-treatment assessments will include: adverse events (AEs), 
concomitant medications, review of stud medication compliance 
-
hr 
h d 
accom1tability, 
physical examinat1011 
, we1~1
ta s1 s blood 
s n ling for safety laboratory tests 
and urine pregnancy tests for ema es o c 1 
earmg potenha only. 
Blood samples will be collected for plasma PK analysis of filgotinib 
and its metabolite GS-829845 at Day I/Baseline and Week 12 (at 
least 30 minutes after dosing), within 2 hours prior to dosing on 
Weeks 4 and/or 6, and anytime at Week 24, 36 and the final 
assessment visit on Week 52/EOT or ET visit. 
Visual ophthalmologic efficacy assessments are described in 
Section 6.3.5 and detailed in the procedures table (Appendix 2). 
These assessments include detennination of the following: 
Best Corrected Visual Acuity (BCVA), tonometry, slit lamp exams 
and dilated indirect ophthalmoscopy with assessments for evidence 
of intraocular inflammation (AC cell grade and VH grade) will be 
conducted in both eyes at all study visits. AC cell and VH grade will 
be detennined according to the NEI/SUN criteria. BCV A 
measurements will be perfonned under standardized lighting 
conditions by certified study examiners with best refractive 
correction in place, using standard logarithmic Early Treatment 
Diabetic Retinopathy Study (ETD RS) visual acuity charts. In the 
ETD RS system, 15 letters is equal to a change of 3 lines of visual 
acuity, for example, from 20/40 to 20/20 or vice versa, a halving or 
doubling of the visual angle; a change of 7.5 letters corresponds to a 
25% decrease or 50% increase in the visual angle. 
Fundus photographs using standardized protocols will be obtained in 
both eyes at Day I/Baseline, at Week 24 and at the Week 52/EOT or 
ET visit. OCT scans using standardized protocols will be assessed in 
both eyes at all visits including Screening, on Day I/Baseline 
(before dosing), and at Week 52/EOT or ET visit. The presence 
versus absence of macular edema is detennined by OCT. 
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Fluorescein angiograms (FA) will be obtained in both eyes on 
Day 1/Baseline (before dosing), Week 24 and at Week 52/EOT or 
ET visit. Additional ophthalmologic assessments (including imaging 
studies) which are done as a part of standard medical care may also 
be collected.
If a subject presents at a site for an Unscheduled visit with 
symptoms related to a uveitis flare, subjects should be evaluated for
treatment failure as detailed in the procedures table (Appendix 2). 
If treatment failure criteria are met, investigators should complete 
EOT procedures. If a subject presents at a site for an Unscheduled 
visit not related to a uveitis flare, investigators should complete 
unscheduled visit procedures at their discretion.
Four week post-treatment follow-up assessments include 
ophthalmologic assessments, AEs, concomitant medications, PE, 
weight, vital signs, blood and urine sampling for safety laboratory 
tests, and urine pregnancy tests for females of child bearing potential 
only. Post-treatment assessments will occur 4 weeks after the last 
dose of study drug.
Test Product, Dose, 
and Mode of 
Administration:
200 mg filgotinib (1 200 mg tablet) administered orally once daily
Reference Therapy, 
Dose, and Mode of 
Administration:
Placebo-to-match (PTM) filgotinib (1 tablet) administered orally 
once daily
Criteria for 
Evaluation:
Safety:
Safety will be assessed by documentation of AEs, clinical laboratory 
tests, vital signs, and physical exams during the study.
Efficacy:
Primary Endpoint

Proportion of subjects failing treatment for active noninfectious 
uveitis by Week 24 
Key Secondary Endpoints

Time to treatment failure at or after Week 6 

Change in VH grade in each eye (NEI/SUN criteria), from best 
state achieved prior to Week 6 to Week 52/EOT or ET visit 

Change in AC cell grade in each eye, from best state achieved 
prior to Week 6 to Week 52/EOT or ET visit 

Change in logMAR BCVA in each eye, from best state achieved 
prior to Week 6 to Week 52/EOT or ET visit 


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
Log change in central retinal thickness in each eye, from best 
state achieved prior to Week 6 to Week 52/EOT or ET visit 

Time to development of macular edema in at least one eye as 
determined by OCT on or after Week 6
Pharmacokinetics:
Plasma concentrations of filgotinib and its metabolite, GS-829845, 
will be analyzed.
Statistical Methods:
The primary analysis set for efficacy analyses will be the Evaluable 
Analysis Set, which includes all randomized subjects who receive at 
least one dose of study drug and do not permanently discontinue 
from the study prior to Week 6.
The primary endpoint is the proportion of subjects failing treatment 
by Week 24. The primary analysis will consist of a superiority test of 
the filgotinib group compared to the placebo group based on the 
proportion of subjects failing treatment by Week 24. The Cochran-
Mantel-Haenszel approach adjusting for the stratification factors will 
be used for the hypothesis testing of the primary endpoint. 
The hypothesis testing of the following secondary endpoints will 
commence after the primary endpoint reaches statistical significance, 
and will be tested according to the hierarchical testing principle at 
the same significance level as the primary endpoint. That means, if a 
null hypothesis is not rejected for the higher ranked secondary 
endpoint, formal sequential testing will be stopped and only nominal 
significance will be reported for the remaining key secondary 
endpoints.

Time to treatment failure on or after Week 6

Change in VH grade in each eye (NEI/SUN criteria), from best 
state achieved prior to Week 6 to Week 52/ EOT visit or ET visit 

Change in AC cell grade in each eye, from best state achieved 
prior to Week 6 to Week 52/ EOT visit or ET visit 

Change in logMAR BCVA in each eye, from best state achieved 
prior to Week 6 to Week 52/ EOT visit or ET visit

Log change in central retinal thickness in each eye, from best 
state achieved prior to Week 6 to Week 52/ EOT visit or ET visit 

Time to development of macular edema in at least one eye as 
determined by OCT on or after Week 6 


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All continuous endpoints will be summarized using an 8-number 
summary (n, mean, standard deviation [SD], median, 1st quartile 
[Q1], 3rd quartile [Q3], minimum, maximum) by treatment group. 
All categorical endpoints will be summarized by the number and 
percentage of subjects who meet the endpoint definition.
Safety endpoints will be analyzed by the number and percent of 
subjects with events or abnormalities for categorical values or 
8-number summary (n, mean, SD, median, Q1, Q3, minimum, 
maximum) for continuous data by treatment group.
Sample size calculations are based on published data from the 
VISUAL I trial {Jaffe 2016}. Assuming the observed proportion of 
subjects failing treatment by Week 24 is 70% in the placebo group, 
107 subjects per treatment group will provide at least 85% power to 
detect a reduction of 20% in the proportion of subjects with 
treatment failure by Week 24 in the filgotinib group using a 2-sided 
significance level of 0.05. Given an expected attrition rate of 15%, a 
total of 248 subjects will need to be randomized into the study.
An interim analysis for efficacy and futility will be conducted when 
approximately 50% of enrolled subjects have either completed their 
Week 24 visit or discontinued from the study before Week 24.
An efficacy analysis will be performed on the proportion of subjects 
failing treatment by Week 24, using the CMH approach adjusting for 
the stratification factors. The rejection boundary for efficacy will be 
based on a significance level of 0.001. A non-binding futility rule is 
defined as a predictive power (i.e., the probability of obtaining a 
statistically significant result at the final analysis given the observed 
interim data) being < 20%. If the Data Monitoring Committee 
(DMC) recommends early termination of the study, an internal 
Gilead team who are not involved with the study may perform an 
unmasked review of the interim data to determine the path forward. 
Gilead retains final decision-making authority on all aspects of the 
study.
To control for the overall type I error rate at 0.05, an alpha of 
0.001 will be spent for the filgotinib group comparison to the 
placebo group based on the Haybittle-Peto boundaries at the interim 
analysis. As a result, an adjusted 2-sided significance level of 0.0498 
will be used to declare statistical significance for the final primary 
analysis.
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
AC
anterior chamber
ADL
activities of daily living
AE
adverse event
ALT
alanine aminotransferase
ANA
antinuclear antibody
AST
aspartate aminotransferase
AUC
area under the curve
BCVA
best corrected visual acuity
BLQ
below the limit of quantitation
CD
Crohn’s Disease
CIA
collagen-induced arthritis
CI
Confidence interval
Cmax
maximum observed plasma concentration
CMH
Cochran-Mantel-Haenszel
CMV
Cytomegalovirus
CNS
central nervous system
CTCAE
Common Terminology Criteria for Adverse Events
CVEAC
cardiovascular safety endpoint adjudication committee
CXR
Chest X Ray
CYP
cytochrome
DMC
data monitoring committee
DNA
deoxyribonucleic acid
DAS28
Disease Activity Score based on 28 joints
EAU
experimental autoimmune uveitis
ECG
electrocardiogram
eCRF
electronic case report form
EOT
end of treatment
ET
early termination
ETDRS
Early Treatment Diabetic Retinopathy Study 
EU
European Union
FA
fluorescein angiogram
FAS
Full Analysis Set
FDA
Food and Drug Administration
FDG-PET
fluorodeoxyglucose-positron emission tomography
FSH
follicle stimulating hormone
FTA
flourescent treponemal antibody
GCP
Good Clinical Practice
CCI


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Gilead
Gilead Sciences Inc. 
GI
gastrointestinal
GLP
Galapagos
HBsAg
Hepatitis B surface antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HIV-1
human immunodeficiency virus type 1
HR
hazard ratio
HSV
herpes simplex virus
HTLV-1
Human T-Lymphotropic Virus Type 1
HZV
Herpes Zoster virus
IB
investigator’s brochure
IC50
half maximal inhibitory concentration
ICF
informed consent form
ICH
International Council for Harmonization
IEC
Independent Ethics Committee
IL
interleukin
IMP
investigational medicinal product
IRB
institutional review board
IWRS
interactive web response system
JAK
janus kinase
logMAR
logarithm of the minimal angle of resolution
MedDRA
Medical Dictionary for Regulatory Activities
MTX
Methotrexate
NEI/SUN
National Eye Institute/Standardization of Uveitis Nomenclature
OAT
Organic Anion Transporters
OCT
optical coherence tomography
PE
Physical exam
PK
Pharmacokinetics
PPD
Purified protein derivative
PT
preferred term
PTM
PVE
Placebo to match
Pharmacovigilance and Epidemiology 
RA
rheumatoid arthritis
RNA
ribonucleic acid
SAE
serious adverse event
SAP
Statistical Analysis Plan
SD
standard deviation
CCI
CCI


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SI
International System of Units
SOC
System Organ Class
SOP
standard operating procedure
STAT
signal transduction and activation of transcription
SUSAR
suspected unexpected serious adverse reactions
TB
Tuberculosis
TEAEs
treatment-emergent adverse events
TNFα
tumor necrosis factor alpha
TYKs
tyrosine kinases
UC
ulcerative colitis
UGTs
uridine 5’-disphosphate glucuronosyltransferases
ULN
upper limit of normal
US
United States
VEGF
vascular endothelial growth factor
VH
vitreous haze
CCI
CCI
CCI


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1.
INTRODUCTION
1.1.
Background
Filgotinib is a selective Janus kinase 1 (JAK1) inhibitor that is being developed for the treatment 
of multiple inflammatory diseases including rheumatoid arthritis (RA), Crohn’s disease (CD) and 
ulcerative colitis (UC). Uveitis is a syndrome of intraocular inflammation resulting from a 
heterogeneous group of diseases including infection, systemic immune-mediated diseases, and 
conditions confined primarily to the eye. Epidemiologic studies estimate the incidence of uveitis 
in the United States (US) at around 17-52 cases per 100,000 person-years {Gritz 2004}. 
The majority of uveitis cases involve the anterior uveal tract and are controlled successfully with 
topical therapy. However, approximately 20% of uveitis cases involve other areas of the eye, 
primarily the vitreous (intermediate uveitis), the choroid or retina (posterior uveitis), or the entire 
eye (panuveitis) {Jabs 2005}. These intermediate-, posterior-, and pan-uveitis subtypes are 
challenging to control and often require systemic or peri/intraocular corticosteroid therapies. 
While effective, corticosteroid-based regimens are frequently associated with adverse 
complications, including glaucoma and cataracts. In addition, these subtypes of uveitis generally 
represent those forms considered vision-threatening, with uveitis accounting for approximately 
10% to 15% of legal blindness cases in the US {Durrani 2004, Nussenblatt 1990}. Noninfectious 
intermediate-, posterior- and pan-uveitis affects men and women in equal numbers, and occurs in 
every age group, including children {Gritz 2004, Jabs 2008}. As a result, it has the potential to 
account for a disproportionately large number of years of potential vision lost when compared to 
more prevalent sight-threatening diseases in which onset occurs in later years. This places uveitis 
on par with diseases such as diabetic retinopathy and macular degeneration as a cause of lost 
years due to visual morbidity and makes it a substantial public health problem. 
Noninfectious sight-threatening uveitis occurring posterior to the lens is often treated with
corticosteroids, the only globally approved therapeutic for uveitis. Off-label use of other 
antimetabolite or cytotoxic agents such as methotrexate is also common. Recently, adalimumab
(Humira®) was approved for the treatment of noninfectious intermediate-, posterior- and 
pan-uveitis, and is presently the only US Food and Drug Administration (FDA) and European 
Medicines Agency-approved non-corticosteroid therapy available for adult patients in this 
disease population. Adalimumab was associated with significantly lower risk of treatment failure 
when compared to placebo in 2 pivotal Phase 3 trials, VISUAL-I and VISUAL-II {Jaffe 2016, 
Nguyen 2016}. In both trials, treatment failure was defined as having one or more of the 
following components affecting at least one eye: 1) increase in anterior chamber cells or vitreous 
haze, 2) new inflammatory chorioretinal or retinal vascular lesions, or 3) decrease in visual 
acuity. In VISUAL-I, subjects with active uveitis on adalimumab were significantly less likely to 
experience treatment failure when compared to those on placebo (hazard ratio [HR]  0.50; 
95% confidence interval [CI]  0.36, 0.70) {Jaffe 2016}. Likewise, in VISUAL-II, adalimumab 
significantly reduced the risk of treatment failure in subjects with inactive uveitis requiring 
control with systemic steroids (HR
0.57; 95% CI
0.39, 0.84) {Nguyen 2016}. 
However, significant treatment failure rates were still observed within the adalimumab arms of 
each clinical trial by the end of the respective treatment observation periods (approximately 65% 


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and 45% in VISUAL-I and-II, respectively). While therapies for sight-threatening uveitis are 
advancing, it is still a condition associated with significant morbidity, limited safe and 
efficacious treatment options, and hence a significant unmet therapeutic need still exists globally.
1.2.
Filgotinib
1.2.1.
General Information
Janus kinases (JAKs) are intracellular cytoplasmic tyrosine kinases (TYKs) that transduce 
cytokine signaling from membrane receptors through signal transducers and activators of 
transcription (STATs) to the nucleus of cells. JAK inhibitors block the signaling of various 
cytokines, growth factors, and hormones, including the pro-inflammatory cytokine interleukin 
(IL)-6.
Four different types of JAKs are known, JAK1, JAK2, JAK3, and TYK2 which co-interact with
different sets of membrane receptors. Inhibition of JAKs is a promising therapeutic option for a
range of inflammatory conditions including RA and CD. 
Filgotinib (GS-6034, formerly GLPG0634) is a potent and selective inhibitor of JAK1. 
The compound has shown good preliminary efficacy in phase 2 RA and CD studies, DARWIN 1
{Westhovens 2017} and DARWIN 2 {Kavanaugh 2017} and Fitzroy {Sandborn 2013}.
In humans, filgotinib is metabolized to form one major metabolite GS-829845 (formerly
G254445). Though the potency of this metabolite in inhibiting JAK-1 is lower than the parent 
molecule, the overall exposure and peak plasma concentration in humans is higher than seen in 
all tested animal species. As a consequence, dedicated pharmacology and toxicology studies 
have also been performed with GS-829845. For further information on filgotinib, refer to the 
current investigator’s brochure (IB).
1.2.2.
Nonclinical Pharmacology and Toxicology
1.2.2.1.
Nonclinical Pharmacology, Absorption, Distribution, Metabolism, and Excretion 
and Toxicology
Filgotinib and GS-829845 have been extensively characterized in nonclinical studies. 
This program includes cellular assays demonstrating potency and selectivity of the compound 
against JAK1, efficacy studies in rats and mice, repeat dose toxicity studies (up to 26 weeks in 
the rat and 39 weeks in the dog), in vitro and in vivo safety pharmacology and genetic toxicology 
studies, and reproductive toxicology studies in rats and rabbits. Additional toxicology studies 
conducted include phototoxicity studies and dose-range finding studies in support of a definitive 
rat juvenile toxicity study and a 6-month carcinogenicity study in transgenic (TgrasH2) mice. A 
pre- and post-natal development study and a 2-year rat oral carcinogenicity study in rats were 
completed.


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1.2.2.2.
Primary and Secondary Pharmacology
Filgotinib is an adenosine triphosphate-competitive inhibitor of JAK1. It is highly selective for 
inhibition of JAK1 over 451 other kinases evaluated in vitro. In cellular assays, it inhibits 
JAK/STAT-driven processes with half maximal inhibitory concentration (IC50) values from 
179 nM onwards. In human whole blood, JAK1 is inhibited by filgotinib with an IC50 of 629 nM 
and exhibits approximately 30-fold selectivity over JAK2. Filgotinib demonstrated significant 
efficacy in the rat collagen-induced arthritis (CIA) model as well as in the mouse dextran 
sulphate sodium (DSS)-induced colitis model.
Metabolite GS-829845 exhibits a similar JAK1 selectivity profile but is approximately 10 to
20-fold less potent than the parent filgotinib in in vitro assays. GS-829845 was as effective as
filgotinib in the rat CIA model, but at doses that required a 10-fold higher exposure.
1.2.2.3.
Safety Pharmacology
Filgotinib and GS-829845 had no effects on the respiratory system and central nervous system
(CNS) in rats up to respectively 40- and 5-fold the exposure in RA subjects given filgotinib 
200 mg daily. Filgotinib and GS-829845 had no relevant effects on cardiovascular parameters 
(human ether-a-go-go-related gene and dog telemetry studies), apart from a slight non-adverse
increase in heart rate and arterial pressure with GS-829845 at exposures 7-fold that of the Cmax in
subjects with RA treated with 200 mg daily filgotinib. There were no relevant effects on ECG 
and QT.
1.2.2.4.
Nonclinical Absorption, Distribution, Metabolism, and Excretion
Filgotinib demonstrates good oral bioavailability in mice, rats, dogs, and minipigs but less in
monkeys. Plasma protein binding is low (< 70%) in all species, including humans.
The pharmacokinetics (PK) of filgotinib is generally dose proportional without gender
differences. No accumulation occurs with repeated dosing. The mean terminal half-life after oral
administration is 4 and 5 hours (h) in rats and dogs, respectively.
In the rat, filgotinib showed a rapid and even distribution throughout the body. 
High concentrations were observed only in the gastrointestinal (GI) tract and urinary bladder.
Filgotinib does not penetrate into central nervous system tissues. The distribution of filgotinib 
indicates some affinity for melanin-containing tissues. A single oral dose administered to the rat 
resulted in significant distribution to the eye including the uveal tract. Specifically, quantitative 
whole body autoradiography data following a single dose of [14C]-radiolabeled filgotinib to
partially pigmented rats demonstrated that the eye:blood ratio for total radioactivity was 2.5 and 
3.3 at 1 and 5 hours post-dose, respectively.
Excretion is nearly complete within 24 h (rat) and 48 h (dog) post-dosing. In the rat, fecal and
urinary excretion accounted for 40% and 53% of the administered dose, respectively, with a bile


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secretion of about 15%. In the dog, fecal excretion was the primary route of excretion,
accounting for 59% of the administered dose, with urinary excretion accounting for 25%.
In vitro metabolism studies in all species revealed one major metabolite (GS-829845). 
The formation of GS-829845 is mediated by carboxylesterases and is not dependent on
cytochrome P450 (CYP).
In vitro experiments have shown that drug-drug interactions with filgotinib and GS-829845 are
unlikely. There is no inhibition or induction of CYPs or uridine 5’-disphosphate
glucuronosyltransferases (UGTs), and no relevant inhibition of key drug transporters, including
the organic anion transporters (OATs), by filgotinib or GS-829845. Organic cation transporter 2 
(OCT2) was inhibited by both filgotinib (IC50: 8.7 uM) and GS-829845 (IC50: 67 uM). 
The clinical relevance of the IC50 values for inhibition of OCT2 will be further evaluated. 
MATE1 was also weekly inhibited by filgotinib (IC50: 94 uM) and GS-829845 (IC50: >100 uM). 
Filgotinib is a substrate of p-glycoprotein (P-gp)
1.2.2.5.
Nonclinical Toxicology
In repeat oral dose toxicity studies in both rats and dogs, the primary target tissues identified for
filgotinib were the lymphoid tissues which is expected based on the pharmacology of JAK
inhibition. Additional filgotinib-related findings were observed in the male reproductive organs
of both species, and in the incisor teeth of rats only. Ophthalmology and histological evaluations 
did not reveal any ocular findings. Effects on the lymphoid system were fully reversible. 
Testicular toxicity demonstrated partial reversibility, however sperm counts remained low. 
A dose of 200 mg/day of filgotinib results in an estimated mean clinical AUC of 2.80 μg∙h/mL, 
which represents an exposure margin of 2.3, 1.8, and 3.4-fold when considering the mean AUC 
in male dogs at the no-observed-effect-levels in the 26 week and 39 week chronic toxicity 
studies, and the 39 week targeted exposure toxicity study, respectively.
GS-829845-related findings in general repeat dose toxicity studies were similar to those of the
parent filgotinib, however no testicular toxicity was noted following administration of
GS-829845.
Filgotinib and GS-829845 were non-genotoxic when evaluated in the bacterial mutagenicity
assay, the in vitro mouse lymphoma mutagenicity assay, and the rat bone marrow micronucleus
assay.
In embryofetal development studies, filgotinib and GS-829845 caused embryolethality and/or
teratogenicity in rats and rabbits at exposures similar to the human exposure at 200 mg daily of
filgotinib in subjects with RA. Administration of filgotinib did not affect female fertility but
impaired fertility was observed in male rats at exposures approximately 15-fold the human
exposure at 200 mg of filgotinib in subjects with RA. GS-829845 did not have any effects on
fertility parameters in either male or female rats.


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In an in vitro phototoxicity study in 3T3 cells, the metabolite GS-829845 was positive for
phototoxic potential and results with filgotinib were equivocal. A follow-up in vivo rat
phototoxicity assay revealed a lack of phototoxic potential for both compounds.
A detailed description of all nonclinical studies conducted with filgotinib can be found in the IB.
1.2.3.
Clinical Trials of Filgotinib
Comprehensive data from the Phase 1, 2 and ongoing 3 programs are available to support the 
development of filgotinib. A detailed description of all clinical studies can be found in Section 4 
of the IB.
1.3.
Rationale for This Study
Noninfectious intermediate-, posterior- and pan-uveitis is a sight-threatening chronic 
relapsing-remitting inflammatory ocular disease. Novel oral therapies that are effective and 
well-tolerated are needed to optimally manage this patient population.
Filgotinib is a potent and selective JAK1- inhibitor that is currently in clinical development for 
the treatment of multiple inflammatory conditions including rheumatoid arthritis (IND 115500), 
Crohn’s disease (IND 129646), and ulcerative colitis (IND 129646). Comprehensive data from 
Phase 1 and 2 studies support Phase 3 programs for RA, CD and UC. Gilead has not yet 
evaluated filgotinib’s efficacy for treating uveitis but its mode of action suggests that it may
provide therapeutic benefit. Moreover, RA, CD, and UC are all inflammatory diseases which are 
sometimes complicated by the development of uveitis {Acharya 2013}. Despite the 
heterogeneity of diseases implicated in immune-mediated uveitis, most are thought to be due to 
an imbalance between regulatory mechanisms inhibiting the immune system and inflammatory 
pathways that evolved to fight infection. Animal models of experimental autoimmune uveitis 
(EAU) implicate an array of cytokines {Horai 2011}. These include anti-inflammatory IL-10, 
TGF-β, and IL-35 produced by regulatory T lymphocytes designed for immunomodulation. 
In contrast, IL-6, IL-17, IL-23, IFN-γ, and TNF-α are produced by T-Helper cell populations 
(Th1 and Th17) resulting in leukocyte recruitment and subsequent tissue damage {Amadi-Obi 
2007}. These activation/inhibition processes are mediated by complex signaling pathways that 
involve JAK and signal transduction and activation of transcription (STAT) signaling. 
Although there are currently no clinical trials with a JAK inhibitor for the treatment of 
noninfectious uveitis, topical tofacitinib (a JAK inhibitor) was reported to reduce intraocular 
inflammation in a rat EAU model {Huang 2013}. 
The present study is designed to compare the proportion of subjects with active noninfectious
intermediate-, posterior- or pan-uveitis at enrollment who meet the definition of treatment failure
at Week 24 in those treated with filgotinib as opposed to placebo, despite the use of systemic 
corticosteroid therapy. According to published recommendations of an expert panel, the target 
recruitment population is representative of one in whom immunosuppressive agents should be 
considered for maintenance therapy of ocular inflammation {Jabs 2000}. The objective is to 
determine whether filgotinib is effective in controlling uveitis while reducing and discontinuing 
systemic corticosteroids. Subjects will be allowed to continue on only one other 


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immunosuppressive agent during the study. Given the lack of a globally-approved highly 
efficacious therapy, placebo is the most appropriate control group to measure the effectiveness of
filgotinib in controlling the subject's uveitis. All subjects randomized will receive a standardized 
prednisone taper to treat the uveitis present at study entry. Regardless of randomization to 
filgotinib or PTM, subjects meeting criteria for treatment failure at Week 6 or any visit thereafter 
will be switched to a standard of care therapy determined by the site investigator. 
Subjects enrolled in this study will have active disease despite at least 2 weeks of oral
corticosteroid therapy. These subjects are candidates for a systemic immunosuppressive therapy 
such as filgotinib to allow potential reduction and/or discontinuation of oral corticosteroid 
therapy.
1.3.1.
Rationale for Dose Selection
Enrolled subjects will be randomized to filgotinib (200 mg) or placebo. The 200 mg daily dose 
regimen of filgotinib is based on the sight-threatening nature of this condition, the desire to 
achieve efficacious ocular and systemic exposures of filgotinib, and on the efficacy and safety 
data from the Phase 1 and 2 studies.
Quantitative whole body autoradiography following a single dose of [14C]-radiolabeled filgotinib
to partially pigmented rats demonstrated total radioactivity results compatible with significant 
penetration into the eye, an affinity for melanin-containing tissue (skin and uveal tract), and 
clearing over time. Altogether, this suggests that oral administration of filgotinib in the proposed 
study will result in systemic and ocular levels to test the clinical efficacy of filgotinib for 
noninfectious intermediate- posterior- and pan-uveitis.
In Phase 1 studies conducted in healthy subjects (eg, GPLG0634-CL-101, -102, -103, -104, -105,
-107, and -110), filgotinib administered at doses up to 450 mg daily for up to 10 days was safe 
and well tolerated. In the two Phase 2a studies in subjects with RA (Study GLPG0634-CL-201 
and -202), a condition sometimes complicated by uveitis, dosing with filgotinib was well 
tolerated and achieved a high level of efficacy at a 200 mg daily dose (ACR20 response of 
75-92% at Week 4). Administration of a higher filgotinib dose (300 mg) did not demonstrate 
greater efficacy, therefore, the dose to be tested in this study will be 200 mg daily.
In two Phase 2b studies, filgotinib at total daily doses of 50, 100, or 200 mg, administered in 
addition to a background therapy with MTX (GLPG0634-CL-203) or as monotherapy 
(GLPG0634-CL-204) was shown to be safe and efficacious in subjects with moderately to 
severely active RA who had an inadequate response to MTX alone. Exposure-response analysis 
based on data from all Phase 2 studies indicated a dose-dependent increase in efficacy 
(ACR20/50/70, DAS28[CRP]), with a plateau at the 200 mg total daily dose on the 
dose-response curve. These results are consistent with the relationship observed between 
filgotinib exposures and pSTAT1 activation (ex-vivo) following single and multiple filgotinib 
doses, where maximal inhibition of pSTAT1 (~78%) was achieved at or above 200 mg total 
daily dose {Namour 2015}. 


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Safety data collected across Phase 2 clinical studies showed no dose-dependent trends in the 
incidence of AEs or serious AEs (SAEs), including infections, or laboratory abnormalities with 
the exception of a numerical increase in select GI AEs (eg, nausea, vomiting, abdominal pain, 
and upper abdominal pain). This numerical increase was observed at 200 mg compared to the 
100 mg dose. However, the overall frequency was low and clinical relevance is unknown. 
Filgotinib, administered at a dose of 200 mg daily was found to be safe and well tolerated. 
The safety profile was consistent with that observed for an immunomodulatory compound 
administered to subjects with RA.
Overall, a 200 mg once-daily dose regimen has been proposed based on the safety and efficacy 
data from the Phase 2 studies and the observed plateau in the pSTAT1 response which indicates 
doses above 200 mg are unlikely to add additional benefit. Since no difference in filgotinib PK 
or pharmacodynamics (JAK1 inhibition) is expected between subjects with RA, CD and uveitis, 
a 200 mg QD filgotinib dose is expected to be well tolerated in subjects with uveitis. This same 
filgotinib dose is also expected to provide clinical benefit in controlling the intraocular
inflammation associated with this sight-threatening condition.
1.4.
Risk/Benefit Assessment for the Study
The safety profile for filgotinib is informed by results from nonclinical and clinical studies 
evaluating a wide range of doses. More information about the known and expected benefits, 
risks, and reasonably anticipated adverse events (AEs) may be found in the IB. Information on 
adverse drug reactions associated with filgotinib may be found in Section 6.2.5. of the IB. 
In general, filgotinib has been well tolerated in all populations studied. An independent data 
monitoring committee (DMC) appointed to monitor this study will provide an additional level of 
oversight. 
Filgotinib is contraindicated in pregnancy; highly effective contraception is to be used across all 
clinical studies to mitigate this risk. Measures to minimize other potential risks to subjects will 
include site/investigator training regarding monitoring for infection, and collection of AEs of 
special interest, including major adverse cardiac events, malignancies, infections, and specific 
laboratory abnormalities.
Nonclinical studies in rats and dogs identified lymphoid tissues and testes as target organs for 
filgotinib in long-term repeat-dose toxicity studies. Although decreased lymphocyte numbers 
observed in nonclinical studies have not been seen in clinical studies, hematological assessment 
will be performed throughout the present study to ensure this potential risk is appropriately 
monitored. In both rats and dogs, microscopic findings in the testes included germ cell depletion 
and degeneration, with reduced sperm content and increased cell debris in the epididymis and 
reduction in fertility in rats. The dog was determined to be the most sensitive species. 
When using the AUC at the NOELs in dogs in the 26 week and 39-week chronic toxicity studies, 
and the 39-week targeted exposure toxicity study, the exposure margins compared with the 
highest proposed clinical dose of 200 mg once daily are 2.3, 1.8 and 3.4-fold, respectively, in 
subjects with RA. A male safety study in subjects with UC is on-going to examine the potential 
effect of filgotinib on semen parameters. 


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Filgotinib has shown an increased risk of embryofetal malformations in rats and rabbits at 
exposures similar to human doses; the use of highly effective contraception in the subject 
population is expected to mitigate this risk.
No clinically relevant impact on cardiovascular parameters (including vital signs and ECG), 
respiratory or neurologic function has been observed in Phase 1 and 2 trials of filgotinib, 
including a dedicated Phase 1 study to evaluate the effect of filgotinib on the QT / QTc interval 
in healthy subjects. The QT study evaluated filgotinib at doses of 200 mg and 450 mg; neither 
dose led to prolongation in the QTc interval or was associated with clinically significant ECG 
changes. In Phase 2 trials in RA, filgotinib was well tolerated. In the RA studies (including the 
open label extension DARWIN 3), infections were reported more commonly in the filgotinib 
groups, including serious infections leading to hospitalization, and even death. The most 
common system organ classes (SOCs) with AEs were infections and infestations, and GI 
disorders. Dose dependent decreases in the Phase 2b studies were observed in mean neutrophil 
counts and platelet counts (but mean changes in both remained within normal laboratory 
reference ranges) and there were no decreases in lymphocytes or lymphocyte subsets. 
Hemoglobin levels slightly improved (increased) with filgotinib treatment, confirming that no 
anemia was induced. Mild and clinically insignificant serum creatinine increases were noted in 
both Phase 2b studies, with stabilization by Week 24. Neutrophil decreases (in the RA 
population) and a potential increased risk of infection may be considered risks consistent with 
the mechanism of JAK inhibition. Overall clinical findings and laboratory changes are consistent 
with selective JAK1 inhibition.
Preclinical and clinical data of filgotinib indicate that this novel agent has a potential to offer 
therapeutic benefit in autoimmune and inflammatory diseases including uveitis. Filgotinib has an 
acceptable level of risk that is consistent with that of other immunomodulatory agents used in 
patient populations with autoimmune diseases. Given the clinical data to date, as well as the 
overall safety, tolerability, and PK characteristics, there is a favorable benefit/risk profile for 
development of filgotinib in noninfectious sight-threatening intermediate-, posterior- or 
pan-uveitis. 
1.5.
Compliance
This study will be conducted in compliance with this protocol, GCP, and all applicable 
regulatory requirements.


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2.
OBJECTIVES
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 as measured by the proportion of subjects failing 
treatment for active noninfectious uveitis by Week 24
The secondary objectives of this study are:

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the time to treatment failure (on or after Week 6) 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in VH grade in each eye (NEI/SUN criteria), from best state 
achieved prior to Week 6 to Week 52/End of Treatment (EOT) or Early Termination (ET)
visit 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in AC cell grade in each eye, from best state achieved prior to 
Week 6 to Week 52/EOT or ET visit 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in logMAR BCVA in each eye, from best state achieved prior to 
Week 6 to Week 52/EOT or ET visit 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in central retinal thickness in each eye, from best state achieved 
prior to Week 6 to Week 52/EOT or ET visit

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the time to development of macular edema in at least one eye as determined 
by OCT (on or after Week 6) 

To evaluate the safety and tolerability of filgotinib 

To evaluate the pharmacokinetics of filgotinib and its metabolite GS-829845


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3.1. 
Endpoints 
The primary endpoint of this study is: 
Final 
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• 
Proportion of subjects failing treatment for active noninfectious uveitis by Week 24 
The secondary endpoints of this study are: 
• 
Time to treatment failure on or after Week 6 
• 
Change in VH grade in each eye (NEI/SUN criteria), from best state achieved prior to 
Week 6 to Week 52/ EOT visit or ET visit 
• 
Change in AC cell grade in each eye, from best state achieved prior to Week 6 to 
Week 52 / EOT visit or ET visit 
• 
Change in logMAR BCV A in each eye, from best state achieved prior to Week 6 to 
Week 52/EOT visit or ET visit 
• 
Log change in central retinal thickness in each eye, from best state achieved prior to Week 6 
to Week 52/EOT or ET visit 
• 
Time to development of macular edema in at least one eye as detennined by OCT on or after 
Week6 
• 
Phannacokinetic characteristics for filgotinib and its metabolite GS-829845 
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3.2.
Study Design
This is a randomized, double-masked, placebo-controlled Phase 2 trial in adult subjects with 
active noninfectious intermediate-, posterior-, or pan-uveitis in at least one eye despite at least 
2 weeks of maintenance therapy with oral prednisone at a dose of ≥ 10 mg/day to ≤ 60 mg/day 
(or oral corticosteroid equivalent). The study is designed to evaluate the efficacy and safety of 
filgotinib in adult subjects requiring high dose steroids for active noninfectious intermediate-, 
posterior-, or pan-uveitis.
A total of approximately 248 healthy male and non-pregnant or non-lactating female subjects 
who are ≥18 years of age, with active, noninfectious intermediate-, posterior-, or pan-uveitis will 
be enrolled into the study. 
Subjects will be randomized in a 1:1 ratio to receive filgotinib 200 mg once daily or Placebo to 
Match (PTM) once daily for up to 52 weeks. Subjects that meet the definition of treatment 
failure (Section 3.5.2) prior to the end of the study (Week 52 visit) will have an EOT visit or ET 
visit (as appropriate). Subjects that discontinue from the study for any other reason before Week 
52 will have an ET visit. Subjects that early terminate should also complete the 4-Week Post-
Treatment Follow-Up Visit. 
To enhance the safety monitoring during the study, a DMC consisting of independent experts 
will be convened to periodically review the accumulating safety data for the study.
In addition, an independent adjudication committee governed by a charter will be set up to 
perform adjudication of potential major adverse cardiovascular events as well as 
thromboembolic events reported during the study. The adjudication of these events will be 
performed in a blinded fashion for the purposes of data analysis and not for monitoring of subject 
safety. 
Additional information regarding the logistics of adjudication will be described in the charter.
A schematic of this study is provided in Figure 3-1.


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Figure 3-1.
Study Schema
3.3.
Study Treatments
Eligible subjects will be randomized in a 1:1 ratio to receive filgotinib 200 mg once daily 
(n
124) or PTM once daily (n  124) for up to 52 weeks.
3.3.1.
Dosage and Administration of Prednisone 
All subjects will receive a standardized prednisone burst of 60 mg/day at Day 1/Baseline 
followed by a protocol-defined mandatory taper schedule, as outlined below (Table 3-1), in 
which all subjects continuing in the study will be off prednisone no later than Week 15.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 


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Table 3-1.
Prednisone Taper Schedule
Study Week
Prednisone Dose (mg/day)
Week 0 (Day 1)
60
1
60
2
50
3
40
4
30
5
20
6
15
7
12.5
8
10
9
7.5
10
5
11
4
12
3
13
2
14
1
15
Discontinued Prednisone
Subjects who enroll in the study on topical ocular corticosteroids will undergo a standardized 
taper schedule beginning at Day 1/Baseline. Subjects must be off topical ocular corticosteroids 
by Week 9. Depending on the dose that the subject is on at the Day 1/Baseline visit, the number 
of drops per day will be decreased every week at the increments indicated in Table 3-2 below:
Table 3-2.
Topical Ocular Corticosteroid Taper Schedule
Dose Taper Schedule per Week
12 drops per day
10 drops per day
8 drops per day
6 drops per day
5 drops per day
4 drops per day
3 drops per day
2 drops per day
1 drop per day
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All subjects will be able to continue their stable dose of oral uveitis control medications provided 
the subject is taking only one of the allowable medications (within the specified dose range) 
detailed in Section 5.4.1 (Allowed Concomitant Medications). Study medication will be 
dispensed and subjects and/or their care-giver will be instructed on the dosing schedule.
3.4.
Duration of Treatment
Subjects will receive a maximum of 52 weeks of study drug.
3.5.
Discontinuation Criteria
3.5.1.
Study Drug Interruption Considerations
The Medical Monitor should be consulted prior to study drug interruption when medically 
feasible.
Study drug interruption should be considered in the following circumstances; prior to resumption
of study drug, the investigator should discuss the case with the Medical Monitor:

Intercurrent illness that would, in the judgment of the investigator, affect assessments of
clinical status to a significant degree

Subject is scheduled for elective or emergency surgery (excluding minor skin procedures 
under local or no anesthesia); timing of study drug pausing should be determined in
consultation with the Medical Monitor

Any subject who develops a new infection during the study should undergo prompt and 
complete diagnostic testing appropriate for an immunocompromised individual, and the 
subject should be closely monitored
NOTE: During the time of study drug interruption for any of the above, the subject may continue
to have study visits and to take part in procedures and assessments, if deemed medically
appropriate by the investigator.
3.5.2.
Study Drug Discontinuation Criteria
The Medical Monitor should be consulted prior to study drug discontinuation for reasons other 
than meeting treatment failure criteria or the subject desiring early termination, when medically 
feasible.
Study drug should be permanently discontinued in the following instances:

Any opportunistic infection

Any serious infection that requires antimicrobial therapy or hospitalization, or any infection
that meets SAE reporting criteria

Complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or 
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
Evidence of active HCV during the study, as evidenced by HCV ribonucleic acid (RNA) 
positivity

Evidence of active HBV during the study, as evidenced by HBV deoxyribonucleic acid 
(DNA) positivity

Any thromboembolic event that meets SAE reporting criteria

Development of any tuberculosis infection

Subject has a positive purified protein derivative PPD test or positive (or indeterminate 
re-test) QuantiFERON®-TB Gold test (or IGRA equivalent)

Unacceptable toxicity, or toxicity that, in the judgment of the investigator, compromises the
subject’s ability to continue study-specific procedures or is considered to not be in the
subject’s best interest; consultation should be made with the Medical Monitor

Subject request to discontinue for any reason

Death

Subject noncompliance

Pregnancy during the study; refer to Section 7.7.2.1

Discontinuation of the study at the request of Gilead, a regulatory agency or an institutional
review board (IRB)/Independent Ethics Committee (IEC)

Subject use of prohibited concurrent therapy may trigger study drug discontinuation;
consultation should be made with the Medical Monitor

Laboratory Criteria: After becoming aware of any of the below described abnormal
laboratory changes occurring at any one time, an unscheduled visit (ie, sequential visit)
should occur to retest within 3 to 7 days (except creatinine, which should be retested 7 to
14 days apart).
a) 2 sequential neutrophil counts < 750 neutrophils/mm3 (SI: < 0.75 x 109 cells/L)
b) 2 sequential (3 to 5 days apart) platelet counts < 75,000 platelets/mm3
(SI: < 75.0 x 109 cells/L)
c) 2 sequential AST or ALT > 3 times the upper limit of normal range (ULN) and ≥1 total
bilirubin > 2 x ULN or accompanied by symptoms consistent with hepatic injury


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d) 2 sequential AST or ALT > 5 x ULN
e) 2 sequential values for estimated creatinine clearance < 35 mL/min based on the
Cockcroft-Gault formula {Cockcroft 1976}
If a subject discontinues study dosing (eg, as a result of an AE), every attempt should be made to 
keep the subject in the study and continue to perform the required study-related follow-up and 
procedures. If this is not possible or acceptable to the subject or investigator, the subject may be 
withdrawn from the study.
Subjects withdrawing from the study for reasons other than treatment failure should complete the 
Early Termination Visit and are encouraged to complete the 4-Week Post-Treatment Follow-Up 
Visit. Subjects are free to withdraw from the study at any time without providing reason(s) for 
withdrawal and without prejudice to further treatment. The reason(s) for withdrawal will be 
documented in the electronic case report form (eCRF).
Reasonable efforts will be made to contact subjects who are lost to follow-up. All contacts and
contact attempts must be documented in the subject’s file.
The sponsor has the right to terminate the study at any time in case of safety concerns or if
special circumstances concerning the study medication or the company itself occur, making
further treatment of subjects impossible. In this event, the investigator(s) and relevant authorities
will be informed of the reason for study termination.
3.5.3.
Study Discontinuation Due to Treatment Failure
Beginning at Week 6 and for all visits thereafter, subjects will be examined for evidence of 
treatment failure. Treatment failure will be defined as a subject meeting at least one of the 
following criteria (Table 3-3) in at least 1 eye:
Table 3-3.
Treatment Failure Criteria
Parameter
Treatment Failure *
Week 6 Visit
All Visits After Week 6
Inflammatory chorioretinal and/or 
inflammatory retinal vascular lesions
New active, inflammatory lesions 
relative to Day 1/Baseline
New active, inflammatory lesions 
relative to Day 1/Baseline
Anterior Chamber Cell grade 
(SUN Criteria)
Inability to achieve
≤ grade 0.5+
2-step increase relative to best 
state achieved **
Vitreous Haze grade 
(NEI/SUN Criteria)
Inability to achieve
≤ grade 0.5+
2-step increase relative to best 
state achieved **
Visual Acuity Early Treatment 
Diabetic Retinopathy Study 
(ETDRS)
Worsening of BCVA by 
≥15 letters relative to best state 
achieved 
Worsening of BCVA by 
≥15 letters relative to best state 
achieved 
*
To be considered a treatment failure, ≥ 1 of these criteria need to be present in at least 1 eye. “Best state” refers to the best 
measures recorded at all prior visits.
**
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Subjects with evidence of treatment failure (assessed at any scheduled or unscheduled visit at or 
after Week 6) will be discontinued from the study and should complete the EOT Visit and the 4-
Week Post-Treatment Follow-Up Visit per Appendix 2. These subjects will be subsequently 
treated at the discretion of the investigator. 
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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
A sufficient number of subjects will be screened to ensure that approximately 248 subjects with 
active, noninfectious intermediate-, posterior-, or pan-uveitis will be randomized to one of 
two dosing groups during the masked treatment phase of the study. Both of the subject's eyes 
must be clinically evaluable for the purpose of determining eligibility based on inclusion and 
exclusion criteria, and for the purpose of assessing Treatment Failure. There will be no 
designated "study eye." It is anticipated that approximately 25% of the included subjects will 
have their uveitis attributed to sarcoidosis.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1) Judged to be in good health as determined by the investigator based on the results of medical 
history, laboratory screening profile, physical examination, chest x-ray, and 12-lead 
electrocardiogram performed during Screening
2) A negative serum pregnancy test is required for female subjects of childbearing potential as 
outlined in Appendix 5.
3) Male subjects and female subjects of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol specified method(s) of contraception as described in
Appendix 5
4) Lactating females must agree to discontinue nursing before the study drug is administered
5) Male or female subjects who are ≥18 years of age on the day of signing informed consent
6) Diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
7) 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 at least 2 weeks of maintenance therapy 
with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:
a) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
b) ≥ 2+ anterior chamber cells (SUN criteria)
c) ≥ 2+ vitreous haze (NEI/SUN criteria)
8) On oral prednisone ≥ 10 mg/day to ≤ 60 mg/day (or oral corticosteroid equivalent) for 2 or 
more weeks immediately prior to and including Day 1/Baseline 


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9) Documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up 
to 1 mg/kg/day)
10) Subjects must meet one of the following 3 TB Screening criteria: 
a) No evidence of active or latent TB:
○
A negative QuantiFERON® TB-Gold In-Tube test at screening, or evidence of 
negative result within the 3 months prior to screening,
○
A chest radiograph (views as per local guidelines) taken at screening or within the 
3 months prior to screening (with the report or films available for investigator review) 
without evidence of active or latent TB infection,
○
No history of either untreated or inadequately treated latent TB infection
b) Previously treated for TB:
○
A subject who has previously received an adequate course of therapy as per local 
standard of care for either latent TB (eg, 9 months of isoniazid in a location where 
rates of primary multi-drug resistant TB infections are < 5% or an alternative regimen 
according to local country guidelines) or active TB (acceptable multi-drug regimen). 
In these cases, no QuantiFERON® TB-Gold Plus In-Tube test (or a centrally reported 
equivalent assay) needs to be obtained
○
A chest radiograph must be obtained, if not done within 3 months prior to Screening, 
(with the report or films available for investigator review)
○
It is the responsibility of the investigator to verify the adequacy of previous anti-TB 
treatment and provide appropriate documentation
c) Newly identified latent TB during Screening:
○
A subject who has a newly identified positive diagnostic TB test result (defined as a 
positive QuantiFERON® TB Gold Plus In-Tube test or equivalent assay), in which 
active TB has been ruled out and for which appropriate ongoing treatment for latent 
TB has been initiated for at least 4 weeks prior to the first administration of study 
drug.
○
Adequate treatment for latent TB is defined according to local country guidelines for 
immunocompromised patients.
Cases falling under category “b” and “c” must be approved by the Gilead Medical Monitor or 
designee prior to enrollment in the study. No subject with currently active TB or untreated latent 
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Subjects with an indeterminate QuantiFERON-TB Gold test result may undergo a repeat test. 
Subjects with a repeat indeterminate test result (two indeterminate results in total) are, in this 
study, considered as having a positive QuantiFERON-TB Gold test result. In the event of a 
negative TB screening test, the results will be interpreted in the context of the subject’s
epidemiology, history, exam findings, etc. 
11) Able and willing to sign the informed consent as approved by the Independent Ethics 
Committee (IEC)/Institutional Review Board (IRB). Written consent must be provided 
before initiating any screening evaluations. Subjects must have read and understood the ICF, 
must fully understand the requirements of the study, and must be willing to comply with all 
study visits and assessments. Subjects who cannot understand the ICF may not be enrolled by 
a guardian or any other individual.
4.3.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) The presence of isolated anterior uveitis
2) The presence of macular edema as the only sign of intermediate-, posterior- or pan-uveitis
3) Intolerance to or prior inadequate response to high-dose oral corticosteroids (equivalent of 
oral prednisone 1 mg/kg/day or 60 to 80 mg/day)
4) 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)
5) Presumed ocular histoplasmosis syndrome (as determined by the investigator)
6) Ocular masquerade syndromes such as ocular lymphoma (as determined by the investigator)
7) Serpiginous choroidopathy
8) Corneal or lens opacity that precludes visualization of the fundus or that likely requires 
cataract surgery during the duration of the trial
9) Subject with elevated intraocular pressures and/or severe glaucoma who is unable to meet the 
following criteria within the screening period:

Intraocular pressure of < 25 mmHg (in at least two consecutive measurements) in the 
absence of therapy or if on a single glaucoma medication

Intraocular pressure of < 21 mmHg (in at least two consecutive measurements) if on 2 or 
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
Subject must have no evidence of glaucomatous optic nerve injury that involves or 
encroaches on central fixation, regardless of intraocular pressure or number of glaucoma 
medications

Subject must have no evidence of glaucomatous optic nerve injury that, in the opinion of 
the investigator, has the potential for splitting fixation or visual acuity loss during the 
course of the study, regardless of intraocular pressure or number of glaucoma 
medications
10) Exposure to a systemic carbonic anhydrase inhibitor within 1 week prior to Screening
11) Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic 
Retinopathy Study) in any eye at the Day 1/Baseline Visit
12) Previous exposure to an approved or experimental JAK inhibitor therapy
13) Any condition preventing the evaluation/assessment of both eyes for eligibility criteria and/or 
for the presence of treatment failure criteria, as detailed in Sections 3.5.3 (either eye can 
satisfy active uveitis criteria for eligibility and either eye may meet treatment failure criteria)
14) Exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy within 4 weeks 
of Day 1/Baseline (as per Section 5.4.2)
15) Received intravitreal anti-VEGF therapy within 45 days of the Day 1/Baseline visit 
[ie, Lucentis® (ranibizumab) or Avastin® (bevacizumab)] or within 60 days of the 
Day 1/Baseline visit for anti-VEGF Trap (ie, aflibercept)
16) Use of more than 1 accepted immunosuppressive therapy (not counting corticosteroids) at 
Day 1/Baseline
17) Using concomitant immunosuppressive therapy at Day 1/Baseline other than methotrexate or 
azathioprine
18) If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased 
within 28 days prior to Day 1/Baseline visit or is not within the following allowable doses:
a) Methotrexate (MTX) ≤ 25 mg per week
b) Azathioprine ≤ 175 mg per day
19) Systemic inflammatory disease requiring continued therapy with oral corticosteroids or a 
prohibited immunosuppressive agent at screening or Day 1/Baseline
20) Received Retisert® (glucocorticosteroid implant) within 3 years prior to the Day 1/Baseline
visit or has had complications related to the device
21) Received intraocular or periocular corticosteroids within 30 days prior to Day 1/Baseline
visit


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22) Presence of proliferative or severe non-proliferative diabetic retinopathy or clinically 
significant macular edema due to diabetic retinopathy
23) Presence of neovascular/wet age-related macular degeneration
24) Presence of a clinically significant abnormality of vitreo-retinal interface per investigator 
discretion (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for 
macular structural damage independent of the inflammatory process
25) Presence of severe vitreous haze that precludes visualization of the fundus at the 
Day 1/Baseline visit
26) Received Ozurdex® (dexamethasone implant) within 3 months prior to the Day 1/Baseline
visit
27) Received intravitreal methotrexate within 90 days prior to the Day 1/Baseline visit
28) Use of cyclophosphamide within 30 days prior to the Day 1/Baseline visit
29) Evidence of any clinically significant (as per the judgement of the investigator) active or 
chronic recurring infection, opportunistic infection, or immunodeficiency syndrome 
30) Severe (anaphylactic) reactions to fluorescein or unwillingness to perform fluorescein 
angiograms
31) Known hypersensitivity to filgotinib, its metabolites, or formulation excipients
32) Contraindication to pupil dilation with mydriatic eye drops
33) History of major surgery (requiring regional block or general anesthesia) or trauma within 
30 days prior to screening
34) History of prior ocular surgery (excluding eyelid surgery) within 90 days before 
Day 1/Baseline with the exception of refractive laser surgery, retinal laser photocoagulation, 
or neodymium-doped yttrium aluminium garnet posterior capsulotomy. These 3 exceptions 
are exclusionary within 30 days before Day 1/Baseline
35) Planned (elective) eye surgery (excluding eyelid surgery) within 52 weeks after 
Day 1/Baseline
36) Any infection requiring hospitalization or treatment with intravenous anti-infectives within 
60 days of screening; or any infection requiring oral anti-infective therapy within 30 days of 
screening
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38) Evidence of active HCV infection. Subjects with positive HCV antibody (Ab) at screening, 
require reflex testing for HCV RNA. Subjects with positive HCV RNA at screening will be 
excluded. Subjects with positive HCV Ab, but negative HCV RNA are eligible per 
investigator judgment. Subjects with active HCV during the study, as evidenced by HCV 
RNA positivity will be discontinued from study drug as outlined in the protocol.
39) Evidence of active HBV infection. Subjects with positive Hepatitis B surface antigen 
(HBsAg) at screening are excluded from the study. Subjects with positive HBV core Ab and 
negative HBsAg, require reflex testing for HBV DNA. Subjects with positive HBV DNA at 
screening will be excluded. Subjects with positive HBV core Ab and negative HBV DNA are 
eligible per investigator judgment, but may require prophylactic treatment in accordance with 
HBV treatment guidelines/local standard of care and require ongoing monitoring with blood 
tests for HBV DNA every 3 months. Subjects with evidence of active Hepatitis B during the 
study, as evidenced by HBV DNA positivity, will be discontinued from study drug as 
outlined in the protocol.
40) Positive test for syphilis (fluorescent treponemal antibody or syphilis IgG; See Appendix 6)
41) History of malignancy within the last 5 years prior to screening (except for adequately treated 
basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical 
carcinoma in situ, with no evidence of recurrence)
42) History of lymphoproliferative disorder or current lymphoproliferative disease
43) History of gastrointestinal perforation
44) History of organ or bone marrow transplant
45) History of leukocytapheresis ≤ 6 months prior to screening
46) Use of any prohibited concomitant medications as described in Section 5.4.2
47) Any chronic, uncontrolled medical condition (including, but not limited to, cardiac or 
pulmonary disease) or psychiatric problem (including, but not limited to alcohol or drug 
abuse) which would put the subject at increased risk during study participation, such as 
uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, 
renal, neurologic or psychiatric disease, or other disease of concern, as per judgment of 
investigator 
48) Administration of a live or attenuated vaccine within 30 days of Day 1/Baseline
49) Not willing to refrain from administration of live or attenuated vaccines during the study and 
for 6 weeks after last dose
50) Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic 
infection (such as pneumocystis, cytomegalovirus [CMV], herpes zoster, and atypical 
mycobacteria). 


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51) History of disseminated Staphylococcus aureus
52) History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any 
history of disseminated herpes simplex, herpes zoster, ophthalmic zoster, or central nervous 
system zoster
53) Current drug use, heavy tobacco use (current use of ≥ 2 packs per day equivalent) or alcohol 
abuse, per investigator judgment
54) Any condition or circumstances which in the opinion of the investigator or sponsor may 
make a subject unlikely or unable to complete the study or comply with study procedures and 
requirements
55) Participation in any clinical study of an investigational drug/device within 4 weeks or 
5 half-lives (whichever is longer) of the drug prior to Day 1/Baseline. Exposure to 
investigational biologics should be discussed with the sponsor.
56) Tests performed at the central laboratory at screening that meet any of the criteria below 
(out of range lab values may be retested one time, at the discretion of the investigator before 
subject is considered a screen-failure):
a) Hemoglobin < 8.0 g/dL (International System of Units [SI]: < 80 g/L);
b) White blood cells < 3.0 x 103 cells/mm3 (SI: < 3.0 x 109 cells/L);
c) Neutrophils < 1.5 x 103 cells/mm3 (SI: < 1.5 x 109 cells/L);
d) Lymphocytes < 0.5 x 103 cells/mm3 (SI: < 0.5 x 109 cells/L);
e) Platelets < 100 x 103 cells/mm3 (SI: < 100 x 109 cells/L);
f)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 x ULN;
g) Total bilirubin level ≥ 2 x ULN unless the subject has been diagnosed with Gilbert’s 
disease and this is clearly documented;
h) Estimated creatinine clearance < 40 mL/min based on the Cockcroft Gault formula
{Cockcroft 1976}


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Masking and Treatment Codes
An Interactive Web Response System (IWRS) will be employed to manage subject 
randomization and treatment assignments. It is the responsibility of the investigator to ensure that 
the subject is eligible for the study prior to enrollment. 
5.1.1.
Masking
Subjects and all personnel directly involved in the conduct of the study will be masked to 
treatment assignment. Specified personnel may be unmasked based on their study role. Study 
drug will be dispensed by the study pharmacist, or designee, in a masked fashion to the subjects. 
The Pharmacokinetics File Administrator, or designee, in Bioanalytical Operations and/or 
Clinical Data Management, who facilitates the data transfer of PK files between Gilead and 
vendors, will remain unmasked. Individuals in Clinical Packaging & Labeling or Clinical Supply 
Management who have an Unblinded Inventory Manager role in the IWRS system for purposes 
of study drug inventory management will remain unmasked. Individuals in Pharmacovigilance 
and Epidemiology (PVE) responsible for safety signal detection, investigational new drug safety 
reporting and/or expedited reporting of suspected unexpected serious adverse reactions 
(SUSARs) may be unmasked to individual case data and/or group level summaries. Separate, 
external (ie, contract research organizations) Biostatisticians and Programmers will be unmasked 
for data monitoring committee and PK/pharmacodynamic data merge. Regulatory Quality and 
Compliance personnel in Research and Development may also be unmasked for purposes of 
supporting Quality Assurance activities and/or Regulatory Agency inspections. 
5.1.2.
Procedures for Breaking Treatment Codes
In the event of a medical emergency where breaking the masking is required to provide medical 
care to the subject, the investigator may obtain treatment assignment directly from the IWRS 
system for that subject. Gilead recommends but does not require that the investigator contact the 
Medical Monitor before breaking the masking designation. Treatment assignment should remain 
masked unless that knowledge is necessary to determine subject emergency medical care. 
The rationale for unmasking must be clearly explained in source documentation and on the 
eCRF, along with the date on which the treatment assignment was obtained. The investigator is 
requested to contact the Medical Monitor promptly in case of any treatment unmasking.
Masking of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the investigator, the subject will have study 
treatment discontinued. All subjects will be followed until study completion unless consent to do 
so is specifically withdrawn by the subject.
Gilead PVE may independently unmask cases for expedited reporting of SUSARs.


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5.2.
Description and Handling of Filgotinib and Placebo-to-Match Filgotinib
5.2.1.
Formulation
Filgotinib tablets, 200 mg, are beige, capsule-shaped, film-coated tablets debossed with “GSI” on 
one side and “200” on the other. Each tablet contains the equivalent of 200 mg filgotinib free 
base in the form of filgotinib maleate. In addition to the active ingredient (filgotinib maleate), 
filgotinib tablets contain the following inactive ingredients: microcrystalline cellulose, lactose 
monohydrate, fumaric acid, pregelatinized starch, silicon dioxide, and magnesium stearate, 
macrogol/PEG 3350, polyvinyl alcohol, talc, titanium dioxide, iron oxide yellow, and iron oxide 
red. 
PTM filgotinib tablets are identical in appearance to the active filgotinib tablets. PTM filgotinib 
tablets contain the following inactive ingredients: microcrystalline cellulose, lactose 
monohydrate, croscarmellose sodium, magnesium stearate, macrogol/PEG 3350, polyvinyl 
alcohol, talc, titanium dioxide, iron oxide yellow, and iron oxide red.
5.2.2.
Packaging and Labeling
Filgotinib tablets, 200 mg, and matching placebo tablets are packaged in white high density 
polyethylene bottles. Each bottle contains 30 tablets, silica gel desiccant and polyester packing 
material. Each bottle is enclosed with a white, continuous thread, child-resistant polypropylene 
screw cap fitted with an induction-sealed, aluminum-faced liner. 
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the United States Food and Drug Administration
(FDA), European Union (EU) Guideline to Good Manufacturing Practice Annex 13 
(Investigational Medicinal Products), and/or other local regulations as applicable.
5.2.3.
Storage and Handling
Study drugs (filgotinib tablets and PTM tablets) should be stored at controlled room temperature 
of 25 °C (77 °F); excursions are permitted between 15 °C and 30 °C (59 °F and 86 °F).
Storage conditions are specified on the label. Until dispensed to the subjects, all bottles of study 
drugs should be stored in a securely locked area, accessible only to authorized site personnel.
To ensure the stability and proper identification, study drugs should not be stored in a container 
other than the container in which they were supplied. Consideration should be given to handling, 
preparation, and disposal through measures that minimize drug contact with the body. 
Appropriate precautions should be followed to avoid direct eye contact or exposure when 
handling.


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5.3.
Dosage and Administration of Filgotinib
Filgotinib 200 mg or matching placebo tablets will be administered once daily with or without 
food. Each subject should be given instructions to maintain approximately the same daily time of 
administration to ensure a similar dosing interval between study drug doses. 
For missed dose(s) of study medication, subjects should be instructed to take the missed dose(s) 
of study medication as soon as possible during the same day. If the missed dose is not taken on 
the original day, subjects should be cautioned not to double the next dose with the missed dose of 
study drug under any circumstances. In those cases, the missed dose should be returned to the 
study drug bottle.
5.4.
Prior and Concomitant Medications
All medications taken up to 30 days prior to the screening visit through the end of the study 
(4 weeks after the last dose of study drug) will be recorded in the source documents and on the 
eCRF. All prior medication(s) used in the treatment for uveitis, are to be documented in the 
eCRF. At each study visit, the study center will capture any and all medications taken by the 
subject since the last visit or during the visit (as applicable). Concomitant medications include 
prescription, non-prescription medications, emollients, oral antihistamines, dietary supplements, 
and minerals.
All uveitis medications should be documented according to the following guidelines:

Historical Uveitis Medications
Any systemic or local therapy for uveitis since initial diagnosis (as determined through 
medical history records or through subject interview) stopped prior to the Screening visit 
will be recorded on the eCRF. The following information on prior uveitis treatments 
should be captured:
■
For prior systemic corticosteroids record the highest dose administered and the date 
range. In addition, the date of the last uveitis flare (the subject's flare prior to the flare 
at Screening) and the dosage of corticosteroid treatment at the time that the flare 
began must be recorded. If the subject was completely off corticosteroids when the 
flare occurred, the date of the last dose of corticosteroid prior to flare must be 
recorded.
■
For immunosuppressants other than systemic corticosteroids record the highest 
previously administered dose and the date range.
■
For topical uveitis therapies record the highest previously administered dose and the 
date range. The medication name should include the strength, if part of the generic 
name (eg, betamethasone phosphate 0.1%). The dose should be recorded as number 
of drops.


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
Current Uveitis Medications
Any systemic or local therapy for uveitis that was ongoing during screening or started at 
or after the screening visit through the end of the study will be recorded on the eCRF.
Effective current therapies should not be discontinued for the sole purpose of participating in this 
study. Subjects may receive medications as supportive care or to treat AEs as deemed necessary 
by the investigator or the subject’s physician. Should subjects have a need to initiate treatment 
with any excluded concomitant medication, the Medical Monitor must be consulted prior to 
initiation of the new medication. In instances where an excluded medication is initiated prior to 
discussion with the sponsor, the investigator must notify Gilead as soon as he/she is aware of the 
use of the excluded medication.


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5.4.1.
Allowed Concomitant Medications 
Allowed concomitant medications should be kept stable for the study duration, as much as 
possible, and include:

Vitamins and hormonal contraceptive medications are permitted.

Acetaminophen and ibuprofen may be used intermittently, as needed.

Inhaled corticosteroids (nasal or oral) are permitted.

Hormone replacement therapy, thyroid replacement and other chronic therapies (such as 
those for well-controlled diabetes or hypertension) are permitted during the study and should 
be kept at a stable dose and regimen, as much as possible.

One of the concomitant immunosuppressive therapies listed below is allowable upon study 
entry as long as the dose has not been increased within 28 days prior to Day 1/Baseline visit 
and is within the following allowable doses at Day 1/Baseline:
Methotrexate (MTX) ≤ 25 mg per week
Azathioprine ≤ 175 mg per day

Dose adjustments for management of toxicity of the above medications are allowed and 
should be documented, along with documentation of the AE which led to the change in the 
medication, otherwise the doses must remain unchanged throughout the study

For subjects with glaucoma, prostaglandin ophthalmic solutions (eg, latanoprost, 
bimatoprost, travoprost, etc.) cannot be initiated nor discontinued during the study. Dosage of 
other topical eye drops for glaucoma may be adjusted as medically necessary during the 
study.

At study entry topical corticosteroids for uveitis are allowed and will be tapered as described 
in Table 3-2.
Female subjects of childbearing potential must agree to use highly effective birth-control 
methods as outlined in Appendix 5 and must agree to continue their use during the study and for 
at least 35 days after the last dose of study medication. The use of hormonal contraceptives will 
be recorded in the Concomitant Therapy section of the eCRF. Applicable procedures and 
treatment guidance based on package inserts will be followed. 
5.4.2.
Prohibited Concomitant Medications 
The prohibited medications while on study drug are as follows:


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Table 5-1.
Prohibited Medications
Drug Class
Agents Disallowed
Prohibited Period
Biologic
All anti-tumor necrosis factor drugs and other 
biologic therapies; Examples include but are 
not limited to: Infliximab, etanercept, 
adalimumab, golimumab, certolizumab, 
abatacept, anakinra, rituximab, natalizumab, 
tocilizumab, efalizumab, ustekinumab,
belimumab or biosimilar agents
4 weeks prior to Day 1/Baseline
through the end of the study or the 
timepoint at which treatment failure 
criteria are identified (with permission 
of the Gilead Medical Monitor), 
whichever occurs first
Any other investigational agent
4 weeks prior to Day 1/Baseline
through the end of the study or 
5 half-lives (whichever is longer)
Prohibited Uveitis and other ocular Medications
Intravitreal Anti-VEGF Therapy for Lucentis 
(ranibizumab) or Avastin (bevacizumab)
45 days prior to Day 1/Baseline through 
the end of the study
Intravitreal Anti-VEGF Therapy for anti-VEGF 
Trap (aflibercept)
60 days prior to Day 1 through the end 
of the study
Use of more than one or any other 
immunosuppressive therapy at Day 1/Baseline 
other than methotrexate ≤ 25 mg per week, or 
azathioprine ≤175 mg per day
Use at Day 1/Baseline and through the 
end of the study or the timepoint at 
which treatment failure criteria are 
identified (with permission of the 
Gilead Medical Monitor), whichever 
occurs first
Retisert (glucocorticosteroid implant)
Received within 3 years prior to 
Day 1/Baseline or has had 
complications with the device and also 
throughout the study
Intraocular or periocular corticosteroids
(including eyelid injections)
Within 30 days prior to Day 1/Baseline
and through the end of the study or the 
timepoint at which treatment failure 
criteria are identified (with permission 
of the Gilead Medical Monitor), 
whichever occurs first
Ozurdex (dexamethasone implant)
Within 3 months prior to Day 
1/Baseline through the end of the study
or the timepoint at which treatment 
failure criteria are identified (with 
permission of the Gilead Medical 
Monitor), whichever occurs first
Intravitreal methotrexate
Within 90 days prior to Day 1/Baseline
and through the end of the study
Cyclophosphamide
Within 30 days of Day 1/Baseline and 
through the end of the study


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Drug Class
Agents Disallowed
Prohibited Period
Corticosteroid with the exception of inhaled 
(nasal or oral) and the mandatory protocol 
specified prednisone taper and the protocol 
specified corticosteroid eye drop taper
Prohibited throughout the trial, 
Reference Section 3.3.1 or the 
timepoint at which treatment failure 
criteria are identified (with permission 
of the Gilead Medical Monitor), 
whichever occurs first
Systemic carbonic anhydrase inhibitor
within 1 week prior to Screening visit 
through the end of the study
Other
Live or attenuated vaccines 
Within 30 days of Day 1/Baseline or 
during study and for 6 weeks post last 
dose of study drug
Strong P-gp Inducersa
Anticonvulsants
Phenobarbital, phenytoin, carbamazepine
21 days prior to Day 1 through the end 
of the study
Antimycobacterials
Rifabutin, rifapentine, rifampin
Herbal/Natural 
Supplements
St. John’s wort, danshen (salvia miltiorrhiza)
a
May decrease study drug exposure and are excluded to avoid potential reduction in study drug activity. PK results indicate 
that filgotinib is a P gp substrate, as a single dose of 200 mg itraconazole (a potent P gp inhibitor) increased filgotinib Cmax
by 64% and AUCinf by 45% and had no effect on the major, active metabolite GS 829845.
For subjects with glaucoma, prostaglandin ophthalmic solutions (eg, latanoprost, bimatoprost, 
travoprost, etc.) cannot be initiated nor discontinued during the study. Dosage of other topical 
eye drops for glaucoma may be adjusted as medically necessary during the study.
At study entry topical corticosteroids for uveitis are allowed and will be tapered as described in 
Section 3.3.1.
5.5.
Vaccine Guidelines
Prior to study participation, it is recommended that the subject’s vaccinations be brought up to 
date according to local vaccination standards.
Live or attenuated vaccines (including, but not limited to varicella and inhaled flu vaccine) are 
prohibited within 30 days of Day 1/Baseline, throughout the study, and for 6 weeks after the 
last dose of study drug.
Subjects should be advised to avoid routine household contact with persons vaccinated with 
live/attenuated vaccine components. General guidelines suggest that a study subject’s exposure 
to household contacts should be avoided for the below stated time periods:

Varicella or attenuated typhoid fever vaccination avoid contact for 4 weeks

Oral polio vaccination - avoid contact for 6 weeks following vaccination


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
Attenuated rotavirus vaccine - avoid contact for 10 days following vaccination

Inhaled flu vaccine - avoid contact for 1 week following vaccination
Inactivated vaccines (such as inactivated flu vaccines) should be administered according to local
vaccination standards whenever medically appropriate; however, there are no available data on
the concurrent use of filgotinib and its impact on immune responses following vaccination.
5.6.
Accountability for Study Drug
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug. This includes acknowledgement of receipt of each shipment of study drug (quantity and 
condition). All used and unused study drug dispensed to subjects must be returned to the site.
Study drug accountability records will be provided to each study site to:

Record the date received and quantity of study drug kits

Record the date, subject number, the study drug kit number dispensed

Record the date, quantity of used and unused study drug returned, along with the initials of 
the person recording the information.
5.6.1.
Study Drug Return or Disposal
At study initiation, the monitor will evaluate the site’s standard operating procedure for 
investigational medicinal product disposal/destruction in order to ensure that it complies with 
Gilead’s requirements. Study drug may be returned or destroyed on an ongoing basis during the 
study if appropriate. At the end of the study, following final drug inventory reconciliation by the 
monitor, the study site will dispose of and/or destroy all unused study drug supplies, including 
empty containers, according to these procedures. If the site cannot meet Gilead’s requirements 
for disposal, arrangements will be made between the site and Gilead’s or its representative for 
destruction or return of unused study drug supplies.
All drug supplies (if applicable) and associated documentation will be periodically reviewed and 
verified by the study monitor over the course of the study.
For additional information about study drug accountability and return, refer to Section 9.1.7. 


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6.
STUDY PROCEDURES
All subjects will have clinic visits at Screening, Baseline/Day 1, and Weeks 1, 4, 6, 8 and then 
every four weeks until Week 52/EOT or ET (if applicable). Treatment failure status will be 
assessed at each clinic visit assessment (scheduled and unscheduled) beginning at Week 6.
All subjects will have clinic visits and procedures as outlined in Appendix 2.
The investigator must document any deviation from protocol procedures and notify the sponsor 
or contract research organization.
6.1.
Subject Enrollment and Treatment Assignment
Subjects will be appropriately consented by the investigator or a medically qualified member of 
the investigator’s study team (eg, MD, DO, nurse practitioner, or research coordinator) and
eligibility will be established at the conclusion of the screening evaluations, within 30 days of 
Day 1/Baseline. The screening number and subject ID will be assigned for each subject by 
IWRS. 
It is the responsibility of the investigator to ensure that each subject is eligible for the study 
before randomization. A subject will be considered enrolled once they have been randomized.
It is the responsibility of the investigator to confirm the presence of active uveitis that satisfies 
enrollment criteria; verification by a central reader will not be required. However, independent 
sequential masked efficacy evaluations by a central reader will be performed for fundus 
photography and OCT measurements in order to standardize measures and monitor their validity 
as described below.
Subjects who do not meet the eligibility criteria will be screen failed; however, these subjects
may be considered for rescreening in consultation with the Sponsor or its designee and providing 
that subject undergoes re-consent. All screening procedures with the possible exceptions noted 
below will be repeated. The subject must meet all inclusion criteria and none of the exclusion 
criteria at the time of re-screening in order to qualify for participation in this trial. There is no 
minimum period of time a subject must wait to re-screen for the study. If the subject had a 
complete initial screening evaluation including the assessment of a QuantiFERON®-TB Gold test
and chest x-ray, these tests will not be required to be repeated for re-screening provided the 
conditions noted in Section 4.2 and Section 6.2.3.7 are met and no more than 30 days have 
passed. Subjects who originally failed screening due to one of the TB screening tests will not be 
eligible to re-screen. As appropriate, sites are encouraged to contact the Medical Monitor to 
confirm if subjects should or should not be re-screened. The Sponsor (including the Medical 
Monitor) must be contacted if a site plans to screen a subject more than twice.
A retest of screening labs is permitted only if there is reason to believe the retest value will be 
within accepted parameters, or if the initial value was either due to a sample processing error or 
an extenuating circumstance.


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6.2.1. 
Study Procedures Descriptions 
Informed Consent 
Final 
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All subjects must sign and date the most recent IRB/ IEC approved infonned consent fonn 
before any study procedures are perfonned. Results from certain tests obtained for standard 
medical care u ose 
· 
· 
· · 
I 
I 
6.2.2. 
Medical History 
A complete medical history will be obtained by the investigator or qualified designee at 
screening and recorded on the eCRF. Medical history will include infonnation on the subject's 
significant past medical events ( eg, prior hospitalizations or surgeries), a review of the disease 
under study, prior and current uveitis medications and any concurrent illnesses. 
A specific uveitis history will be obtained at the Screening Visit. The history will include, but is 
not limited to, collecting the date of onset of uveitis (first flare), which eye(s) is/are affected, the 
type of uveitis, subject history of infectious uveitis and cause of previous infection 
(if applicable), the number of flares within the past 12 months (including the current flare), the 
date of last flare prior to current flare (present at Screening), the prednisone dose at time of 
last flare ( or equivalent prednisone dose, if subject was on another corticosteroid, refer to 
Appendix 7), and date of onset of current flare. 
6.2.3. 
Safety 
Safety will be assessed by documentation of AEs, clinical laboratory tests, vital signs, and 
physical exams during the study. 
6.2.3.1. 
Thromboembolic Events 
Subjects experiencing a thromboembolic event should be evaluated for the overall risk of 
recurrent thromboembolism and referred to a specialist for further testing as appropriate 
(including but not limited to evaluation for an underlying inherited hypercoagulable state). 
6.2.3.2. 
Adverse Events 
Subjects will be assessed for AEs per guidelines in the National Cancer Institute (NCI) CTCAE 
(Version 4.03) at the time points outlined in Appendix 2. Any AEs reported after infonned 
consent is obtained and throughout the study will be recorded on the eCRF with appropriate 
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source documentation. The subject will be assessed for AEs until 30 days after the last dose of 
study drug. Please refer to Appendix 4 CTCAE grading criteria. 
Please refer to Section 7 for additional information on AE reporting. 
6.2.3.3.
Prior and Concomitant Medications 
All medications taken up to 30 days prior to the screening visit and any supportive therapies 
given during the course of the study will be recorded as per Section 5.4.
6.2.3.4.
Complete and Symptom-Driven Physical Examination 
A PE should be performed at the time points indicated in the study procedures table 
(Appendix 2). Any changes from baseline will be recorded. Height will be measured at screening 
only. Body weight will be taken at visits outlined in Appendix 2. 
At screening and Week 52/EOT or the ET Visit, a complete PE will be performed. A complete 
PE should include source documentation of general appearance and the following body systems: 
head, neck, and thyroid; eyes, ears, nose, throat, mouth and tongue; chest (excluding breasts); 
respiratory; cardiovascular; lymph nodes; abdomen; skin, hair, nails; musculoskeletal; and 
neurological. A symptom-driven PE will be performed at all other visits.
6.2.3.5.
Vital Signs
Vital signs will be measured at the time points indicated in the study procedures table 
(Appendix 2). 

Vital signs should be taken after the subject has been resting for at least 5 minutes and will 
include pulse rate, systolic and diastolic blood pressure, and body temperature.
6.2.3.6.
12-lead Electrocardiogram
A resting 12-lead ECG will be performed at the Screening visit only. The ECG should be 
obtained after the subject has been resting in the supine position for at least 5 minutes and will 
include heart rate, inter-beat (RR), QRS, uncorrected QT, morphology, and rhythm analysis. 
QT interval corrected for heart rate according to Fridericia (QTcF) will be recorded. 
Electrocardiograms will be interpreted by the investigator (or qualified designee) for clinical 
significance and results will be entered into the eCRF.
6.2.3.7.
Tuberculosis Screening:
The TB screening tests are diagnostic test results to be interpreted in the context of the subject’s 
epidemiology, history, exam findings, etc. and it is the responsibility of the investigator to 
determine if a subject has previous, active or latent tuberculosis or not in conjunction with a 
negative TB screening test. Subjects with evidence of a negative TB test result within the 
3 months prior to screening will not be required to undergo a re-test at the Screening visit.


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QuantiFERON® positive or negative results must not be repeated. An indeterminate result should 
be repeated once and the second result (if positive or negative) will be accepted. Two sequential 
indeterminate results constitute a screen failure. Subjects with previously treated TB or newly 
identified latent TB during Screening require sponsor approval (See Inclusion Criterion No. 10 
for details). Subjects who are diagnosed with latent TB before/at Screening must initiate an 
adequate course of prophylaxis according to local country guidelines for immunocompromised 
patients for a minimum of 4 weeks prior to randomization. Subject may initiate study drug 
dosing only after consultation with the Gilead Medical Monitor or designee. 
As part of TB screening assessment of a chest x-ray (CXR) is required as described in 
Section 6.2.3.8. 
6.2.3.8.
Chest X-Ray
All subjects will undergo a standard CXR (views as per local guidelines) during the screening 
period to rule out the presence of TB or other clinically relevant findings. If the subject 
previously had a chest x-ray obtained for clinical care reasons within 3 months of screening, this 
may be used to satisfy the CXR requirement (as applicable, see Section 4.2).
6.2.3.9.
Clinical Laboratory Evaluations
The laboratory analyses will be performed at a local or central laboratory at the Screening Visit. 
If repeat laboratory tests are required/obtained during Screening, they must be completed at the 
same location (local or central laboratory) as the original tests. All local tests reference ranges 
will be supplied by the local laboratory and will be used by the investigator to assess the 
laboratory data for clinical significance and study eligibility.
For all other visits, laboratory analyses will be performed via a central laboratory. All central
tests reference ranges will be supplied by the central laboratory and will be used by the 
investigator to assess the laboratory data for clinical significance and pathological changes.
Blood samples will be collected by venipuncture 
 
 in the arm at the time points indicated in the study procedures table 
(Appendix 2). In addition, urine samples for the clinical laboratory assessments will be collected. 
Subjects only need to be fasted (except ET or EOT visit) on days where lipid profiling is 
scheduled (Appendix 2). 

Refer to Appendix 6 for table of clinical laboratory tests.
The laboratory values outside the normal range will be flagged and clinical relevance will be 
assessed by the investigator. More frequent sampling as well as additional tests may be 
performed as deemed necessary by the investigator as indicated. 
CCI


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Note that in the case where clinically significant laboratory test results are a potential reason for 
discontinuation from the study drug and withdrawal from the study, retesting of the affected 
parameter(s) should be perfonned promptly (within 3 to 7 days) after the investigator has 
consulted with the Medical Monitor. A decision regarding subject discontinuation should be 
made after the results from the retest are available (see Section 3.5 for additional infonnation). 
The details of sample handling and shipment instructions will be provided in a separate 
laboratory manual. 
6.3. 
Disease Assessments 
Disease assessments will be perfonned at the time points indicated in the study procedures table 
(Appendix 2). 
I 
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6.3.5. 
Visual Ophthalmologic Efficacy Assessments 
Final 
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Visual Ophthalmologic efficacy assessments are detailed in the procedures table (Appendix 2) 
and include detennination of the following: 
6.3.5.1. 
Best Corrected Visual Acuity Testing 
Refraction and assessment of BCV A will be assessed at each visit. A qualified and trained health 
care professional must perfonn the refraction and BCV A testing. At each visit, subjects should 
undergo refraction with the result recorded for each eye. 
Using the appropriate corrective lenses based on that visit's refraction, subject's BCVA is 
measured using an ETD RS chart. In the ETDRS system, 15 letters is equal to a change in 3 lines 
of visual acuity, for example, from 20/40 to 20/20 or vice versa, a halving or doubling of the 
visual angle; a change of 7.5 letters corresponds to a 25% decrease or 50% increase in the visual 
angle. The ETD RS chart will be specified and provided by Gilead (if required) with further 
instructions and training outlined in a visual acuity manual under separate cover. BCV A will also 
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be collected during the trial if done at unscheduled times for the purposes of standard medical 
care.
6.3.5.2.
Slit Lamp Exam 
The slit lamp exam will be completed at each visit. The following findings will be assessed: 
AC cell count and Age-Related Eye Disease Study (AREDS) lens opacity grading. The AC cell 
count grading will be performed prior to application of mydriatic eyedrops to dilate subject’s 
pupils for further assessment. AREDS lens opacity grading occurs after dilating the subject’s 
pupils as per Appendix 8. Slit lamp exam results will also be collected during the trial if done at 
unscheduled times for the purposes of standard medical care. The AREDS classification does not 
apply if the subject has pseudophakia.
The number of AC cells observed within a 1 mm × 1 mm slit beam will be recorded for each eye. 
The reported number will be used to determine the grade according to the SUN criteria 
(Table 6-1).
Table 6-1.
Anterior Chamber Cells 
Grade
Cells in Field
0
0
0.5+
1-5
1+
6-15
2+
16-25
3+
26-50
4+
>50
Using the AREDS standard photographs as reference, the degree of lens opacity will be graded 
for each type: nuclear, cortical, and posterior subcapsular (PSC) (Table 6-2).
See Appendix 8 for further instructions regarding lens opacity grading procedures.


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Table 6-2.
Lens Opacity Grading
Grading for Nuclear Lens Opacity
< 1.0
no nuclear opacity, or less than NS Std. No. 1
1.0
opacity similar to NS No. 1
1.5
opacity between NS No. 1 and NS Std. No. 2
2.0
opacity similar to NS No. 2
2.5
opacity between NS No. 2 and NS Std. No. 3
3.0
opacity similar to NS No. 3
> 3.0
opacity greater than NS No. 3
8.0
cannot evaluate
Grading for Cortical Lens Opacity
< 1.0
no cortical opacity, or opacity obviously less than CO Std. No. 1
1.0
opacity similar to cortical opacity Std. No. 1
1.5
opacity between CO Std. No. 1 and Std. No. 2
2.0
opacity similar to CO Std. No. 2
2.5
opacity between CO Std. No. 2 and Std. No. 3
3.0
opacity similar to CO No. 3
> 3.0
cortical opacity obviously greater than Std. No. 3
8.0
cannot evaluate
Grading for Posterior Subcapsular (PSC) Opacity
< 1.0
no PSC opacity, or opacity obviously < PSC Std. No. 1
1.0
opacity similar to PSC No. 1
1.5
opacity between PSC No. 1 and Std. No. 2
2.0
opacity similar to PSC No. 2
2.5
opacity between PSC No. 2 and Std. No. 3
3.0
opacity similar to PSC No. 3
> 3.0
PSC obviously greater than PSC No. 3
8.0
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6.3.5.3.
Tonometry
Contact tonometry (Goldmann, Perkins or Tonopen) will be performed at every visit to measure 
the intraocular pressure for both eyes. Contact tonometry is required for this study. The same 
technique should be used for all visits for an individual subject. Tonometry results will also be 
collected during the trial if done at unscheduled times for the purposes of standard medical care.
6.3.5.4.
Dilated Indirect Ophthalmoscopy
Subject’s eyes should be dilated in preparation for indirect ophthalmoscopy with the examination 
technique and instrument used remaining consistent for each subject throughout the study. 
Dilated indirect ophthalmoscopy is performed to determine the vitreous haze grading and the 
presence or absence of active, inflammatory, chorioretinal and/or inflammatory retinal vascular 
lesions. Lesion location(s), number, size(s) and whether the lesions are active or inactive should 
be documented with a retinal drawing in the subject's source documentation, if a lesion is 
identified.
Grading of vitreous haze (Table 6-3) will be based on the publication from the NEI which has 
also been adapted by the SUN working group.
Sites will use the standard photographs given to them by the sponsor and the description in 
Table 6-3 when determining the grade for vitreous haze. 
Table 6-3.
Vitreous Haze Grading
Grade
Description
0
No evident vitreal haze
0.5+
Slight blurring of the optic disc margin because of the haze; normal striations and reflex of 
the nerve fiber layer cannot be visualized.
1+
Permits a better definition of both the optic nerve head and the retinal vessels (compared to 
higher grades)
2+
Permits better visualization of the retinal vessels (compared to higher grades)
3+
Permits the observer to optic nerve head, but the borders are quite blurry
4+
Optic nerve head is obscured
The presence or absence of active inflammatory chorioretinal and/or inflammatory retinal 
vascular lesions will also be determined via dilated indirect ophthalmoscopy at Screening and 
Day 1/Baseline. At all subsequent visits, dilated indirect ophthalmoscopy will be performed to 
determine the presence or absence of new active inflammatory lesions compared to the 
Day 1/Baseline visit, based on the investigator’s clinical judgement. Dilated indirect 
ophthalmoscopy results will also be collected during the trial if done at unscheduled times for the 
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6.3.5.5.
Fundus Photography
Fundus photography will be performed in both eyes at Day 1/Baseline, Week 24 and at the time 
of treatment failure or completion of study (Week 52/EOT or ET). The purpose is to obtain 
documented evidence of the presence or absence of active inflammatory chorioretinal and/or 
inflammatory retinal vascular lesions. The same camera should be used for a given subject 
throughout the study. Fundus photography will also be collected during the trial if done at 
unscheduled times for the purposes of standard medical care.
All fundus photography images will be sent to the central reader. If there is disagreement 
between the investigator's assessment for inflammatory lesions based on dilated indirect 
ophthalmoscopy and central reader's assessment for inflammatory lesions based on fundus 
photograph, the investigator's assessment will take precedence. However, the reason for the 
disagreement must be documented by the investigator. The site must have a discussion with the 
Medical Monitor if the discrepancy is unclear or if further medical discussion is required.
6.3.5.6.
Optical Coherence Tomography
OCT will be performed in both eyes at every visit. Sites must use one of two OCT machines for 
this clinical trial to determine central retinal thickness and the presence of macular edema: 

Cirrus HD-OCT (Carl Zeiss Meditec, Inc.)

Spectralis (Heidelberg Engineering)
Each subject will undergo OCT measurements of the central retinal thickness (1 mm subfield) to 
evaluate for macular edema at every visit using the same protocol approved OCT machine 
throughout the study. OCT measurements at every visit will be captured and sent to the central 
reader. The central reader will evaluate the OCT images and record these findings. Although it is 
preferred to complete the OCT measurements following pupil dilation, it is important that the 
site conducts the scans consistently across each subject (using the same model of OCT device for 
each subject) throughout the study.
OCT will also be collected during the trial if done at unscheduled times for the purposes of 
standard medical care.
6.3.5.7.
Fluorescein Angiogram
Ultra-wide field fluorescein angiograms are preferred and must be used if this equipment is 
available at the site. If this equipment is not available at a specific site, standard FA imaging is 
acceptable. Fluorescein angiograms (FA) will be obtained in both eyes on Day 1/Baseline 
(before dosing), Week 24, and at Week 52/EOT or ET visit. The severity of fluorescein leakage 
and of cystoid spaces will be assessed using a modification of the ETDRS protocol. The area of 
retinal thickening and of cystoid spaces found on concurrently graded FA and color fundus 
photographs will also be noted. The extent of fluorescein leakage will be noted in disc areas. 
Additional retinal morphologic features that will be graded include but are not limited to vascular 


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nonperfusion, choroidal neovascularization, preretinal neovascularization, retinal detachment, 
optic disc edema, glaucomatous optic disc changes, vitreoretinal interface abnonnalities (such as 
epiretinal membrane) and their relationship to macular edema, and chorioretinal lesions (FA with 
sweep fields). Morphologic features in most cases are measured as dichotomous variables 
(present or absent), and if present, their extent is graded. Additional imaging studies done as a 
part of standard medical care may also be collected. These images will all be sent to the central 
reader for interpretation. The same instrument should be used for the same subject assessments 
throughout the study. 
6.3.6. 
Viral Monitoring: HCV and HBV 
Subjects with positive HCV antibody (Ab) at screening, require reflex testing for HCV RNA. 
Subjects with positive HCV RNA at screening will be excluded. Subjects with positive HCV Ab, 
but negative HCV RNA are eligible per investigator judgment. Subjects with active HCV during 
the study, as evidenced by HCV RNA positivity will be discontinued from study drug as outlined 
in the protocol. 
Subjects with positive HBsAg at screening are excluded from the study. Subjects with positive 
HBV core Ab and negative HBsAg, require reflex testing for HBV DNA. Subjects with positive 
HBV DNA at screening will be excluded. Subjects with positive HBV core Ab, and negative 
HBV DNA are eligible per investigator judgment, but may require prophylactic treatment in 
accordance with HBV treatment guidelines/local standard of care and require ongoing 
monitoring with blood tests for HBV DNA every 3 months. Subjects with evidence of active 
Hepatitis B during the study, as evidenced by HBV DNA positivity, will be discontinued from 
study drug as outlined in the protocol. 
6.4. 
Pharmacokinetics Assessments 
Blood samples will be collected for plasma PK analysis of filgotinib and its metabolite 
GS-829845 at Day 1/Baseline and Week 12 (at least 30 minutes after dosing), within 2 hours 
prior to dosing on Weeks 4 and/or 6, and anytime at week 24, 36 and the final assessment visit 
on Week 52/EOT or ET visit as detailed in Appendix 2. 
6.6. 
End of Treatment 
End of treatment for a subject is defined as the date of the last study-related procedure or the date 
of death for an on-study subject. 
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6.7.
Unscheduled Visit Attributed to Uveitis Symptoms
If a subject presents at a site for an unscheduled visit with symptoms related to a uveitis flare, 
subjects should be evaluated for treatment failure criteria. If treatment failure criteria are met, 
investigators should complete EOT procedures. If a subject presents at a site for an unscheduled 
visit not related to a uveitis flare, investigators should complete unscheduled visit procedures at 
their discretion.
6.8.
End of Study
End of Study (EOS) is defined as when the last enrolled subject has either completed the 
Week 52 visit or met the criteria for treatment failure or early terminated (plus the 4-Week Post-
Treatment Follow-Up Visit if applicable).


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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse 
Events
7.1.1.
Adverse Events
An AE is any untoward medical occurrence in a clinical study subject administered a medicinal 
product, which does not necessarily have a causal relationship with the treatment. An AE can 
therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated 
with the use of a medicinal product, whether or not considered related to the medicinal product.
AEs may also include pre- or post-treatment complications that occur as a result of protocol 
specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational 
exposure. Preexisting events that increase in severity or change in nature during or as a 
consequence of participation in the clinical study will also be considered AEs.
An AE does not include the following:

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion.
The condition that led to the procedure may be an AE and must be reported.

Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen

Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae (see Section 7.7)

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
CRF.
7.1.2.
Serious Adverse Events
An SAE is defined as an event that, at any dose, results in the following:

Death

Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.)

In-patient hospitalization or prolongation of existing hospitalization


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
Persistent or significant disability/incapacity

A congenital anomaly/birth defect

A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. For the avoidance of doubt, infections resulting from contaminated medicinal 
product will be considered a medically important event and subject to expedited reporting 
requirements.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.
7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship to
investigational medicinal product (IMP) therapy using clinical judgment and the following 
considerations:

No: Evidence exists that the AE has an etiology other than the IMP. For SAEs, an alternative 
causality must be provided (eg, pre-existing condition, underlying disease, intercurrent 
illness, or concomitant medication).

Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of AE reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:

No: Evidence exists that the AE has an etiology other than the study procedure.

Yes: The AE occurred as a result of protocol procedures (eg, venipuncture)


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7.2.2.
Assessment of Severity
The severity of AEs will be graded using the modified CTCAE, version 4.03. For each episode,
the highest grade attained should be reported. For AEs associated with laboratory abnormalities,
the event should be graded on the basis of the clinical severity in the context of the underlying
conditions; this may or may not be in agreement with the grading of the laboratory abnormality.
If a CTCAE criterion does not exist, the investigator should use the grade or adjectives: Grade 1 
(mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) or Grade 5 (fatal) to 
describe the maximum intensity of the AE. For purposes of consistency with the CTCAE, these 
intensity grades are defined in Table 7-1 and Appendix 4.
Table 7-1.
Grading of Adverse Event Severity
Grade
Adjective
Description
Grade 1
Mild
Asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated 
Grade 2
Moderate
Local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL 
Grade 3
Severe
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; 
limiting self-care ADL 
Grade 4
Life-threatening
Urgent intervention indicated 
Grade 5
Death 
Death related AE 
*
Activities of Daily Living (ADL) Instrumental ADL refer to opening preparing meals, shopping for groceries or clothes, 
using the telephone, managing money, etc. 
**
Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to Gilead 
Requirements for collection prior to study drug initiation:
After informed consent, but prior to initiation of study medication, the following types of events 
should be reported on the eCRF: all SAEs and AEs related to protocol-mandated procedures.
Adverse Events
Following initiation of study medication, collect all AEs, regardless of cause or relationship, 
until 30 days after last administration of study drug(s). All AEs must be reported to the eCRF 
database as instructed.
All AEs should be followed up until resolution or until the AE is stable, if possible. Gilead 
Sciences may request that certain AEs be followed beyond the protocol defined follow-up 
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All SAEs, regardless of cause or relationship, that occurs after the subject first consents to 
participate in the study (ie, signing the infonned consent) and throughout the duration of the 
study, including the protocol-required post treatment follow-up period, must be reported to the 
eCRF database and Gilead Phannacovigilance and Epidemiology (PYE) as instructed. This also 
includes any SAEs resulting from protocol-associated procedures perfonned after infonned 
consent is signed. 
Any SAEs and deaths that occur after the post treatment follow-up visit but within 30-days of the 
last dose of study IMP, regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol defined follow-up period; 
however, if the investigator learns of any SAEs that occur after study participation has concluded 
and the event is deemed relevant to the use of IMP, he/she should promptly document and report 
the event to Gilead PYE. 
In the intended study population, Gilead anticipates the occurrence of uveitis-related AEs/SAEs. 
These uveitis-related events include those that are manifestations of the underlying disease which 
c01mnonly occur in the study population independent of drug exposure, and/or are components 
contributing to the study endpoints ( e.g., band keratopathy, vitreous hemorrhage). The investigator 
will detennine if a specific AE/SAE is uveitis-related and record it in a specific field in the eCRF. 
All AEs and SAEs will be recorded in the eCRF database within the timelines outlined in the 
eCRF completion guideline. 
Electronic Serious Adverse Event ( eSAE) Reporting Process 
• 
Site perso1mel record all SAE data in the eCRF database and from there trans1nit the SAE 
infonnation to Gilead PYE within 24 hours of the investigator's knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines. 
• If for any reason it is not possible to record the SAE infonnation electronically, i.e., the 
eCRF database is not functioning, record the SAE on the paper SAE reporting fonn and 
submit within 24 hours to: 
Gilead PVE: 
Fax: 
E-mail: 
• 
As soon as it is possible to do so, any SAE reported via paper must be transcribed into the 
eCRF Database according to instructions in the eCRF completion guidelines. 
• If an SAE has been reported via a paper fonn because the eCRF database has been locked, no 
further action is necessary. 
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
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.

Additional information may be requested to ensure the timely completion of accurate safety 
reports.

Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s eCRF and the event description section of the SAE form.
7.4.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), or 
SUSARs. In accordance with the EU Clinical Trials Directive (2001/20/EC), Gilead or a 
specified designee will notify worldwide regulatory agencies and the relevant IEC in concerned 
Member States of applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the investigator’s brochure or relevant local label as applicable.
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study IMP. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments 
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (eg, clinical chemistry, hematology, and urinalysis) independent of the 
underlying medical condition that require medical or surgical intervention or lead to 
investigational medicinal product interruption or discontinuation must be recorded as an AE, as 
well as an SAE, if applicable. In addition, laboratory or other abnormal assessments 
(eg, electrocardiogram, X-rays, vital signs, ocular assessments) that are associated with signs 
and/or symptoms must be recorded as an AE or SAE if they meet the definition of an AE (or 
SAE) as described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part of a 
syndrome, record the syndrome or diagnosis (ie, anemia) not the laboratory result (ie, decreased 
hemoglobin).


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Adverse events will be coded using the most recent version of the Medical Dictionary for 
Regulatory Activities (MedDRA). Severity should be recorded and graded according to the 
Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, which can be 
found at: http://www.hrc.govt.nz/sites/default/files/CTCAE%20manual%20-%20DMCC.pdf 
For AEs associated with laboratory abnormalities, the event should be graded on the basis of the 
clinical severity in the context of the underlying conditions; this may or may not be in agreement 
with the grading of the laboratory abnormality.
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3 and as outlined below.
For study-specific interruption and discontinuation criteria, refer to Section 3.5
7.6.
Toxicity Management 
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3 and as outlined below. For study-specific interruption and 
discontinuation criteria, refer to Section 3.5. 
Treatment-emergent toxicities will be noted by the investigator and brought to the attention of 
the Medical Monitor, who will have a discussion with the investigator and decide the appropriate 
course of action. Whether or not considered treatment-related, all subjects experiencing AEs 
must be monitored periodically until symptoms subside, any abnormal laboratory values have 
resolved or returned to baseline levels or they are considered irreversible, or until there is a 
satisfactory explanation for the changes observed.
Grade 3 or 4 clinically significant laboratory abnormalities should be managed as outlined in 
Appendix 3 and Sections 7.6.2 and 7.6.3.
7.6.1.
Grades 1 and 2 Laboratory Abnormality or Clinical Event
For Grades 1 and 2 laboratory abnormalities or clinical events not specified in Section 3.5, 
continue study drug at the discretion of the investigator. 
7.6.2.
Grades 3 Laboratory Abnormality or Clinical Event
For Grade 3 laboratory abnormalities or clinical event not specified in Section 3.5, the following 
toxicity management guidelines apply.
For a Grade 3 clinically significant laboratory abnormality or clinical event, study drug may be 
continued if the event is considered to be unrelated to study drug.
For a Grade 3 clinical event, or clinically significant laboratory abnormality confirmed by repeat 
testing, that is considered to be related to study drug, study drug should be withheld until the 
toxicity returns to ≤ Grade 2.


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If a laboratory abnormality recurs to ≥ Grade 3 following re-challenge with study drug and is 
considered related to study drug, then study drug should be permanently discontinued and the 
subject managed according to local clinical practice. Recurrence of laboratory abnormalities 
considered unrelated to study drug may not require permanent discontinuation and study drug 
may be continued at the discretion of the investigator.
7.6.3.
Grades 4 Laboratory Abnormality or Clinical Event
For Grade 4 laboratory abnormalities or clinical events not specified in Section 3.5, the following 
toxicity management guidelines apply.
For a Grade 4 clinical event or clinically significant Grade 4 laboratory abnormality confirmed 
by repeat testing that is considered related to study drug, study drug should be permanently 
discontinued and the subject managed according to local practice. The subject should be 
followed as clinically indicated until the laboratory abnormality returns to baseline or is 
otherwise explained, whichever occurs first. A clinically significant Grade 4 laboratory 
abnormality that is not confirmed by repeat testing should be managed according to the 
algorithm for the new toxicity grade.
Investigational medicinal product may be continued without dose interruption for a clinically 
non-significant Grade 4 laboratory abnormality (eg, Grade 4 creatine kinase (CK) after strenuous 
exercise or triglyceride elevation that is non-fasting or that can be medically managed) or a 
clinical event considered unrelated to study drug.
Any questions regarding toxicity management should be directed to the Medical Monitor.
7.7.
Special Situations Reports
7.7.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit of falsified medicine, and 
pregnancy  regardless of an associated AE.
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of an investigational product while the medication is in the 
control of a health care professional, patient, or consumer. Medication errors may be classified as 
a medication error without an AE, which includes situations of missed dose; medication error 
with an AE; intercepted medication error; or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of an investigational product 
by a subject.
Misuse is defined as any intentional and inappropriate use of an investigational product that is 
not in accordance with the protocol instructions or the local prescribing information.


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An overdose is defined as an accidental or intentional administration of a quantity of an 
investigational product given per administration or cumulatively which is above the maximum 
recommended dose as per protocol or in the product labelling (as it applies to the daily dose of 
the subject in question). In cases of a discrepancy in drug accountability, overdose will be 
established only when it is clear that the subject has taken the excess dose(s). Overdose cannot 
be established when the subject cannot account for the discrepancy except in cases in which the 
investigator has reason to suspect that the subject has taken the additional dose(s).
Occupational exposure is defined as exposure to an investigational product as a result of one’s 
professional or non-professional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a Gilead investigational product.
Counterfeit or falsified medicine: Any investigational product with a false representation of: a) 
its identity, b) its source, or c) its history.
7.7.2.
Instructions for Reporting Special Situations
7.7.2.1.
Instructions for Reporting Pregnancies
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study medication and throughout the study, including the post study drug follow-up 
period, to Gilead PVE using the pregnancy report form within 24 hours of becoming aware of 
the pregnancy.
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on the mechanism 
of pregnancy reporting.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Sections 7.1.1 and 7.1.2. Furthermore, any SAE occurring as an adverse pregnancy outcome post 
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The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to Gilead PVE using the pregnancy outcome report 
form. If the end of the pregnancy occurs after the study has been completed, the outcome should 
be reported directly to Gilead PVE. Gilead PVE contact information is as follows: 
Email: 
and Fax: 
. 
Pregnancies of female partners of male study subjects exposed to Gilead or other study drugs 
must also be reported and relevant information should be submitted to Gilead PVE using the 
pregnancy and pregnancy outcome forms within 24 hours. If the end of the pregnancy occurs 
after the study has been completed, the outcome should be reported directly to Gilead PVE,
fax number 
 or email
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.
7.7.2.2.
Reporting Other Special Situations
All other special situation reports must be reported on the special situations report form and 
forwarded to Gilead PVE within 24 hours of the investigator becoming aware of the situation. 
These reports must consist of situations that involve study IMP and/or Gilead concomitant 
medications, but do not apply to non-Gilead concomitant medications. 
Special situations involving non-Gilead concomitant medications does not need to be reported on 
the special situations report form; however, for special situations that result in AEs due to a 
non-Gilead concomitant medication, the AE should be reported on the AE form. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on the mechanism 
of special situations reporting.
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE eCRF and/or the SAE report form. Details of the symptoms and 
signs, clinical management, and outcome will be reported, when available.
PPD
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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
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 as measured by the proportion of subjects failing 
treatment for active noninfectious uveitis by Week 24
The secondary objectives of this study are: 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the time to treatment failure (on or after Week 6) 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in VH grade in each eye (NEI/SUN criteria), from best state 
achieved prior to Week 6 to Week 52/EOT or ET visit 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis
as measured by the change in AC cell grade in each eye, from best state achieved prior to 
Week 6 to Week 52/EOT or ET visit 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in logMAR BCVA in each eye, from best state achieved prior to 
Week 6 to Week 52/EOT or ET visit 

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in central retinal thickness in each eye, from best state achieved 
prior to Week 6 to Week 52/EOT or ET visit

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the time to development of macular edema in at least one eye as determined 
by OCT (evaluated at all visits on or after Week 6) 

To evaluate the safety and tolerability of filgotinib 

To evaluate the pharmacokinetics of filgotinib and its metabolite GS-829845 


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The primary endpoint is the proportion of subjects failing treatment for active noninfectious 
uveitis by Week 24 as outlined in Table 3-3. 
8.1.3. 
Secondary Endpoint 
The secondary endpoints of this study are: 
• 
Time to treatment failure on or after Week 6 
• 
Change in VH grade in each eye (NEI/SUN criteria), from best state achieved prior to 
Week 6 to Week 52/EOT visit or ET visit 
• 
Change in AC cell grade in each eye, from best state achieved prior to Week 6 to 
Week 52/EOT visit or ET visit 
• 
Change in logMAR BCV A in each eye, from best state achieved prior to Week 6 to 
Week 52/EOT visit or ET visit 
• 
Log change in central retinal thickness in each eye, from best state achieved prior to Week 6 
to Week 52/EOT visit or ET visit 
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Time to development of macular edema in at least one eye as detennined by OCT on or after 
Week6 
• 
Phannacokinetic characteristics for filgotinib and its metabolite GS-829845 
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8.2. 
8.2.1. 
8.2.1.1. 
Analysis Conventions 
Analysis Sets 
All Randomized 
All Randomized Analysis Set includes all subjects who are randomized in the study. This is the 
primary analysis set for by-subject listings. 
8.2.1.2. 
8.2.1.2.1. 
Efficacy 
Evaluable Analysis Set 
The Evaluable Analysis Set is the primary analysis set for efficacy analyses; which includes all 
randomized subjects who receive at least one dose of study drug, and do not pennanently 
discontinue from the study prior to Week 6. 
8.2.1.2.2. 
Full Analysis Set 
The Full Analysis Set (FAS) includes all randomized subjects who receive at least one dose of 
study drug. 
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Per-Protocol Analysis Set 
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The secondary analysis set for efficacy analyses will be the Per-Protocol (PP) Analysis Set, 
which includes all subjects in the Evaluable Analysis Set who do not c01mnit any major protocol 
violation, including the violation of key entry criteria. 
8.2.1.3. 
Safety 
The primary analysis set for safety analyses will be the Safety Analysis Set, which includes all 
subjects who receive at least one dose of study drug. 
8.2.1.4. 
Phannacokinetics 
The PK analysis set includes all subjects in the Safety Analysis Set who have at least 
1 non-1nissing plasma concentration data for filgotinib and/or its metabolite GS-829845. 
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8.3. 
Data Handling Conventions 
PK concentration values and PK parameter values below the limit of quantitation (BLQ) will be 
presented as "BLQ" in the data listings. BLQ values that occur prior to the first dose will be 
treated as 0, BLQ values at all other time points will be treated as 1/2 of the lower limit of 
quanti tation. 
Laboratory data that are continuous in nature but are less than the lower limit of quantitation or 
above the upper limit of quantitation will be imputed to the value of the lower or upper li1nit 
1ninus or plus one significant digit, respectively ( eg, if the result of a continuous laboratory test is 
< 20, a value of 19 will be assigned; if the result of a continuous laboratory test is < 20.0, a value 
of 19.9 will be assigned). 
8.4. 
Demographic Data and Baseline Characteristics 
Demographic and baseline characteristics will be smmnarized by treatment group using standard 
descriptive statistics including sample size, mean, SD, median, Ql, Q3, minimum, and maximum 
for continuous variables and number and percentages of subjects for categorical variables. 
Demographic data will include sex, race, ethnicity, and age. 
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Baseline characteristics may include uveitis attributed to sarcoidosis (yes/no), baseline 
immunosuppressant usage (yes/no), prior use of anti-TNF therapy (yes/no), uveitis types (pan-
uveitis, posterior uveitis, and intermediate uveitis), affected eye (left eye, right eye or both eyes) 
and other variables of interest.
8.5.
Efficacy Analysis
8.5.1.
Primary Analysis
The primary endpoint for the study is the proportion of subjects failing treatment by
Week 24. The primary hypothesis will consist of a superiority test of filgotinib compared to 
placebo based on proportion of subjects failing treatment by Week 24. The 
Cochran-Mantel-Haenszel (CMH) approach adjusting for the stratification factors will be used 
for the hypothesis testing of the primary endpoint. Subjects who are missing sufficient 
measurements to establish efficacy at Week 24 will be considered as failures (i.e. non-responder 
imputation). Sensitivity analyses will be conducted and described in the statistical analysis plan 
(SAP).
Each component of the primary efficacy endpoint will be compared between filgotinib and 
placebo groups using the CMH test adjusting for stratification factors. In the event that the 
number of subjects failing treatment due to any individual component is small, the chi-square 
test or the exact method will be used. The details of the analyses will be provided in the SAP.
There will be one planned interim analysis when approximately 50% of the enrolled subjects 
have either completed their Week 24 visit or discontinued from the study before Week 24. 
To control for the overall type I error rate at 0.05, an alpha of 0.001 will be spent for the 
filgotinib group comparison to the placebo group based on the Haybittle-Peto boundaries at the 
interim analysis. As a result, an adjusted 2-sided significance level of 0.0498 will be used to 
declare statistical significance for the final primary analysis. The details of the interim analysis 
are provided in Section 8.10.
8.5.2.
Secondary Analyses
The hypothesis testing of the following key secondary endpoints will commence after the 
primary endpoint reaches statistical significance, and will be tested according to the hierarchical 
testing principle at the same significance level as the primary endpoint. That means, if a null 
hypothesis for the higher ranked secondary endpoint is not rejected, formal sequential testing 
will be stopped and only nominal significance will be reported for the remaining key secondary 
endpoints.

Time to treatment failure on or after Week 6

Change in VH grade in each eye (NEI/SUN criteria), from best state achieved prior to 
Week 6 to Week 52/EOT visit or ET visit 


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
Change in AC cell grade in each eye, from best state achieved prior to Week 6 to 
Week 52/EOT visit or ET visit 

Change in logMAR BCVA in each eye, from best state achieved prior to Week 6 to 
Week 52/EOT visit or ET visit

Log change in central retinal thickness in each eye, from best state achieved prior to Week 6 
to Week 52/EOT visit or ET visit 

Time to development of macular edema in at least one eye as determined by OCT on or after 
Week 6
For all subjects, the time to treatment failure and the time to OCT evidence of macular edema 
will be based on the first eye to meet the criteria for treatment failure or macular edema. 
The change in anterior chamber cell grade in each eye from best state achieved prior to Week 6 
to Week 52/ET Visit, change in vitreous haze grade in each eye from best state achieved prior to 
Week 6 to Week 52/ET Visit, change in best corrected visual acuity (logarithm of the minimum 
angle of resolution) in each eye from best state achieved prior to Week 6 to Week 52/ET Visit, 
and change in central retinal thickness in each eye from best state achieved prior to Week 6 to 
Week 52/ET Visit will be analyzed using data from each eye individually. The definition of ‘best 
state’ for the VH grade, AC cell grade, BCVA and central retinal thickness will be provided in 
the SAP.
The time to treatment failure on or after Week 6 will be compared between the filgotinib group 
and the placebo group with a stratified log-rank test. A proportional-hazards model with the 
study group as a factor and stratification factors as covariates will be fitted to estimate the hazard 
ratio with its 95% confidence interval. As sensitivity analysis, the time to treatment failure 
between the filgotinib group and the placebo group will be compared using the restricted mean 
survival time. Treatment failures on or after Week 6 will be counted as events and dropouts due 
to reasons other than treatment failure at any time during the study will be considered as 
censored observations at the time of dropping out. The time to macular edema on or after Week 6
will be analyzed in the same way. OCT evidence of macular edema on or after Week 6 will be 
counted as event. Dropouts due to reasons other than OCT evidence of macular edema will be 
considered as censored observations at the time of dropping out.
Change in AC cell grade, change in Vitreous Haze grade, change in BCVA (logarithm of the 
minimum angle of resolution), and change in central retinal thickness will be compared between 
treatment groups using the repeated measures Analysis of Covariance to control for clustered 
observations (i.e., observations from each of the subject's eyes), with treatment as a factor, and 
the stratification factors and baseline values included as covariates. For change in central retinal 
thickness the analysis will additionally be adjusted for type of OCT machines.


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8.6. 
Safety Analysis 
All safety analyses will be perfonned using the Safety Analysis Set. 
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Safety will be evaluated by assessment of clinical laboratory tests, physical examinations, vital 
signs measurements at various time points during the study, and by the documentation of AEs. 
All safety data collected on or after the first dose of study drug administration up to 30 days after 
the last dose of study drug, unless specified otherwise will be smmnarized by treatment group 
according to the study drug received. 
8.6.1. 
Extent of Exposure 
A subject's extent of exposure to study drug will be generated from the study drug 
administration page of the eCRF. Exposure data will be summarized by treatment group. 
Duration of exposure to study drug will be expressed as the number of weeks between the 
first and last dose of the study drug, inclusive, regardless of temporary interruptions in study 
drug administration and summarized by treatment group. 
8.6.2. 
Adverse Events 
Clinical and laboratory AE will be coded using the MedDRA. System Organ Class, High-Level 
Group Tenn , High-Level Tenn , Preferred Tenn (PT), and Lower-Level Tenn will be attached to 
the clinical database. 
Treatment-emergentAEs (TEAEs) are: 
• 
Any AEs with an onset date of on or after the study drug start date and no later than 30 days 
after pennanent discontinuation of study drug or 
• 
Any AEs leading to premature discontinuation of study drug. 
Smmnaries (number and percentage of subjects) ofTEAEs by SOC and PT will be provided by 
treatment group. TEAEs will also be summarized by relationship to study drug and severity. 
In addition, TEAEs leading to premature discontinuation of study drug will be smmnarized and 
listed. 
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Laboratory Evaluations 
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Selected laboratory data will be smmnarized (n, mean, SD, median, Ql, Q3, minimmn, and 
maximmn) by treatment group and study visit along with corresponding change from Baseline. 
The incidence of treatment-emergent graded laboratory abnonnalities will be smmnarized 
similarly. 
Graded laboratory abnonnalities will be defined using CTCAE 4.03 grading scale. 
8.7. 
Pharmacokinetic Analysis 
Plasma concentrations of filgotinib and its metabolite (GS-829845) will be listed and 
smmnarized using descriptive statistics ( eg, sample size, arithmetic mean, geometric mean, 
% coefficient of variation, standard deviation, median, minimum, and maximum). 
Plasma concentrations over time may be plotted in semi logarithmic and linear fonnats as 
mean ± standard deviation and median (Ql, Q3). 
8.9. 
Sample Size 
Sample size calculations are based on published data from the VISUAL I trial {Jaffe 2016}. 
Assumiung the observed proportion of subjects failing treatment by Week 24 is 70% in the 
placebo group, 107 subjects per treatment group will provide at least 85% power to detect a 
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reduction of 20% in the proportion of subjects with treatment failure by Week 24 in the filgotinib 
group using a 2-sided significance level of 0.05. Given an expected attrition rate of 15%, a total 
of 248 subjects will need to be randomized into the study.
8.10.
Data Monitoring Committee (DMC)
An external multidisciplinary DMC will review the progress of the study and perform interim 
reviews of safety data and provide recommendation to Gilead whether the nature, frequency, and 
severity of adverse effects associated with study treatment warrant the early termination of the 
study in the best interests of the participants, whether the study should continue as planned, or 
the study should continue with modifications. The DMC will also assess efficacy and futility on 
the primary endpoint at the pre-defined interim analysis time points.
An interim analysis for efficacy and futility will be conducted when approximately 50% of 
enrolled subjects have either completed their Week 24 visit or discontinued from the study
before Week 24. The efficacy analysis will be performed for the primary endpoint, proportion of 
subjects failing treatment by Week 24, using the CMH approach adjusting for the stratification 
factors. The DMC may recommend early termination of the study owing to compelling evidence 
of efficacy using a pre-specified Haybittle-Peto efficacy boundary with a significance level of 
0.001. A non-binding futility rule on the proportion of subjects failing treatment will also be 
implemented. Based upon the analysis results, the DMC may recommend early termination of 
the study for futility if the predictive power (ie, the probability of obtaining a statistically 
significant result at the final analysis given the observed interim data) is < 20%. 
If the DMC recommends early termination of the study, an internal Gilead team who are not 
involved with the study may perform an unmasked review of the interim data to confirm the 
DMC recommendation and decide the path forward. While the DMC will be asked to advise 
Gilead regarding future conduct of the study, including possible early study termination, Gilead 
retains final decision-making authority on all aspects of the study.
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, the timing of planned safety and efficacy analyses, conduct and meeting 
schedule.
8.11.
Ad Hoc DMC Meeting
An ad hoc convening of the DMC may be triggered by the following conditions:

≥2 subjects develop the same (by PT) related, Grade 4, unexpected AE in the infections and 
infestations SOC

≥2 subjects develop any related, Grade 4 thromboembolic event that has been positively 
adjudicated by the independent adjudication committee (Section 8.12)

Any subject develops a Grade 5, related, unexpected AE. The definition of an unexpected AE 
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8.12.
Cardiovascular Safety Endpoint Adjudication Committee (CVEAC)
An independent adjudication committee will be formed to periodically review and adjudicate all 
potential major adverse cardiovascular events and thromboembolic events in a blinded manner.
The CVEAC’s specific activities will be governed by a mutually agreed charter, which will 
define the CVEAC’s membership, conduct, and meeting schedule.
The following events will be adjudicated and classified by the CVEAC:

Cardiovascular death

Myocardial infarction

Stroke

Arterial thromboembolism

Venous thromboembolism (eg, deep venous thrombosis, pulmonary embolism)
Further details will be specified in the CVEAC Charter.


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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with ICH E6(R2) 
addendum to its guideline for GCP and applicable laws and regulations.
9.1.2.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of their 
financial interest or arrangements with Gilead, or proprietary interests in the investigational drug 
during the course of a clinical study. This documentation must be provided prior to the 
investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify Gilead of any change in reportable interests during the study and 
for 1 year following completion of the study. Study completion is defined as the date when the 
last subject completes the protocol-defined activities.
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the subject 
(such as advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC. The investigator will not begin any study subject activities 
until approval from the IRB/IEC has been documented and provided as a letter to the 
investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study subjects.
9.1.4.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study before undertaking any study-related procedures. The investigator 
must use the most current IRB- or IEC-approved consent form for documenting written informed 
consent. Each informed consent (or assent as applicable) will be appropriately signed and dated 
by the subject or the subject’s legally authorized representative and the person conducting the 
consent discussion, and also by an impartial witness if required by IRB or IEC or local 
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The investigator must assure that subjects' anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as year of birth) will be recorded on any fonn 
or biological sample submitted to Gilead, IRB/IEC, or laboratory. Laboratory specimens must be 
labeled in such a way as to protect subject identity while allowing the results to be recorded to 
the proper subject. Refer to specific laboratory instructions NOTE: The investigator must keep a 
screening log with details for all subjects screened and enrolled in the study, in accordance with 
the site procedures and regulations. Subject data will be processed in accordance with all 
applicable regulations. 
The investigator agrees that all infonnation received from Gilead, including but not limited to the 
investigator's brochure, this protocol, eCRF, the study drug, and any other study infonnation, 
remain the sole and exclusive property of Gilead during the conduct of the study and thereafter. 
This infonnation is not to be disclosed to any third party ( except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain. 
9.1.6. 
Study Files and Retention of Records 
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully docmnented and the study data to be subsequently verified. These docmnents should 
be classified into at least the following 2 categories: (1) investigator's study file, and (2) subject 
clinical source documents. 
The investigator's study file will contain the protocol/amendments, paper or electronic 
completed subject CRFs, IRB/IEC and govenunental approval with correspondence, infonned 
consent, drug records, staff curriculum vitae and authorization fonns, and other appropriate 
documents and correspondence. 
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The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification;

Documentation that subject meets eligibility criteria; ie, medical history, physical 
examination, and confirmation of diagnosis (to support inclusion and exclusion criteria);

Documentation of the reason(s) a consented subject is not enrolled

Participation in study (including study number);

Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol-specific procedures were performed;

Results of efficacy parameters, as required by the protocol;

Start and end date (including dose regimen) of study drug, including dates of dispensing and 
return;

Record of all AEs and other safety parameters (start and end date, and including causality 
and severity), and documentation that adequate medical care has been provided for any AE

Concomitant medication (including start and end date, dose if relevant; dose changes);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (ie, United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if 
specified by regulatory requirements, by local regulations, or by an agreement with Gilead. 
The investigator must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another
location, Gilead must be notified in advance.


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If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
9.1.7.
Case Report Forms
For each subject consented, an electronic case report form (eCRF) casebook will be completed 
by an authorized study staff member whose training for this function is completed in the 
EDC system. The eCRF casebook will only capture the data required per the protocol schedule 
of events and procedures. The Inclusion/Exclusion Criteria and Enrollment eCRFs should be 
completed only after all data related to eligibility have been received. Data entry should be 
performed in accordance with the CRF Completion Guidelines (CCGs) provided by the Sponsor. 
Subsequent to data entry, a study monitor will perform source data verification (SDV) within the 
EDC system. System-generated or manual queries will be issued in the EDC system as data 
discrepancies are identified by the monitor or Gilead staff, who routinely review the data for 
completeness, correctness, and consistency. The site investigator or site coordinator or other 
designee is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the reason 
for the update (e.g. data entry error). Original entries as well as any changes to data fields will be 
stored in the audit trail of the system. At a minimum, prior to any interim time points or database 
lock (as instructed by Gilead), the investigator will use his/her log in credentials to confirm that 
the forms have been reviewed, and that the entries accurately reflect the information in the 
source documents. At the conclusion of the study, Gilead will provide the site investigator with a 
read-only archive copy of the data entered by that site. This archive must be stored in accordance 
with the records retention requirements outlined in Section 9.1.6.
9.1.8.
Investigator Inspections
The investigator will make available all source documents and other records for this study to 
Gilead’s appointed study monitors, to IRBs/IECs, or to regulatory authority or health authority 
inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.


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Gilead Sciences, Inc. 
Amendment 4
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9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies). 
Gilead will ensure that the report meets the standards set out in the ICH Guideline for Structure 
and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be 
prepared in certain cases. 
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of 
Gilead in an abstract, manuscript, or presentation form or the study has been completed at all 
study sites for at least 2 years
The investigator will submit to Gilead any proposed publication or presentation along with the 
respective scientific journal or presentation forum at least 30 days before submission of the 
publication or presentation. 
No such communication, presentation, or publication will include Gilead’s confidential 
information (see Section 9.1.5).
The investigator will comply with Gilead’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol, eg, attendance at Investigator Meetings. If required under the applicable statutory and 
regulatory requirements, Gilead will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical study payments, meal, 
travel expenses or reimbursements, consulting fees, and any other transfer of value.


Filgotinib
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Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
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17 March 2020
9.3.2.
Access to Information for Monitoring
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any subject records needed to 
verify the entries in the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both Gilead and the investigator reserve the right to terminate the study at any time. Should this 
be necessary, both parties will arrange discontinuation procedures and notify the subjects, 
appropriate regulatory authority(ies), IRBs, and ECs. In terminating the study, Gilead and the 
investigator will assure that adequate consideration is given to the protection of the subjects’ 
interests.


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Protocol GS–US-432-4097
Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
Page 91
17 March 2020
10.
REFERENCES
Acharya NR, Tham VM, Esterberg E, Borkar DS, Parker JV, Vinoya AC, et al. Incidence and 
Prevalence of Uveitis: Results From the Pacific Ocular Inflammation Study. 
JAMA ophthalmology 2013;131 (11):1405-12.
Amadi-Obi A, Yu CR, Liu X, Mahdi RM, Clarke GL, Nussenblatt RB, et al. TH17 cells 
contribute to uveitis and scleritis and are expanded by IL-2 and inhibited by IL-
27/STAT1. Nat Med 2007;13 (6):711-8.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976;16:31-41.
Durrani OM, Tehrani NN, Marr JE, Moradi P, Stavrou P, Murray PI. Degree, duration, and 
causes of visual loss in uveitis. Br J Ophthalmol 2004;88 (9):1159-62.
Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern 
California Epidemiology of Uveitis Study. Ophthalmology 2004;111 (3):491-500; 
discussion 
Horai R, Caspi RR. Cytokines in autoimmune uveitis. Journal of interferon & cytokine research : 
the official journal of the International Society for Interferon and Cytokine 
Research 2011;31 (10):733-44.
Huang JF, Zhang Y, Hirakawa B. Evaluation of JAK inhibition with topical tofacitinib in an 
experimental autoimmune uveitis model (EAU) [Abstract]. The Association for 
Research in Vision and Ophthalmology (ARVO); 2013 05-09 May; Seattle, WA. 
Jabs DA. Epidemiology of uveitis. Ophthalmic Epidemiol 2008;15 (5):283-4.
Jabs DA, Nussenblatt RB, Rosenbaum JT, Standardization of Uveitis Nomenclature Working 
Group. Standardization of Uveitis Nomenclature for Reporting Clinical Data. 
Results of the First International Workshop. Am J Ophthalmol 2005;140 (3):509-
16.
Jabs DA, Rosenbaum JT, Foster CS, Holland GN, Jaffe GJ, Louie JS, et al. Guidelines for the 
use of immunosuppressive drugs in patients with ocular inflammatory disorders: 
recommendations of an expert panel. Am J Ophthalmol 2000;130 (4):492-513.
Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, et al. Adalimumab in 
Patients with Active Noninfectious Uveitis. N Engl J Med. 2016;375 (10):932-43.
Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko OV, Stanislavchuk M, et al. Filgotinib 
(GLPG0634/GS-6034), An Oral Selective JAK1 Inhibitor, is Effective as 
Monotherapy in Patients with Active Rheumatoid Arthritis: Results from a 


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Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
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17 March 2020
Randomised, Dose-Finding Study (DARWIN 2). Ann Rheum Dis. 2017;76 
(6):1009-19.
Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD, et al. Development of the 
25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol
2001;119 (7):1050-8.
Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, et al. 
Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib 
(GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. 
Clin Pharmacokinet 2015;54 (8):859-74.
Nguyen QD, Merrill PT, Jaffe GJ, Dick AD, Kurup SK, Sheppard J, et al. Adalimumab for 
prevention of uveitic flare in patients with inactive non-infectious uveitis 
controlled by corticosteroids (VISUAL II): a multicentre, double-masked, 
randomised, placebo-controlled phase 3 trial. Lancet 2016;388 (10050):1183-92.
Nussenblatt RB. The natural history of uveitis. International ophthalmology 1990;14 (5-6):303-8.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and 
activity impairment instrument. Pharmacoeconomics 1993;4 (5):353-65.
Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, et al. Vedolizumab 
as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med 
2013;369 (8):711-21.
The EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of 
life. . Health Policy 1990;16 (3):199-208.
Westhovens R, Taylor PC, Alten R, Pavlova D, Enriquez-Sosa F, Mazur M, et al. Filgotinib 
(GLPG0634/GS-6034), An Oral JAK1 Selective Inhibitor, is Effective in 
Combination with Methotrexate (MTX) in Patients with Active Rheumatoid 
Arthritis and Insufficient Response to MTX: Results from a Randomised, Dose-
Finding Study (DARWIN 1). Ann Rheum Dis. 2017;76 (6):998-1008.


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Final
Gilead Sciences, Inc. 
Amendment 4
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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Study Procedures Table
Appendix 3.
Management of Clinical and Laboratory Adverse Events
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 6.
Clinical Laboratory Assessment Table
Appendix 7.
Corticosteroid Conversion Table
Appendix 8.
AREDS 2008 Clinical Lens Opacity Grading Procedures


Filgotinib 
Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DRIVE 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
Final 
Amendment4 
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of 
filgotinib in Subjects with Active Noninfectious Uveitis 
GS-US-432-4097, Amendment 4, 17 March 2020 
This protocol has been approved by Gilead Sciences, Inc. The following signature docwnents 
this a roval. 
PPD 
.... P=P_D;;;;=:::::::::::::::_::------.Printe 
PD 
PPD 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
Page94 
17 March 2020 


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Final
Gilead Sciences, Inc. 
Amendment 4
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Appendix 2.
Study Procedures Table
Screening
Day1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk
12
Wk
16
Wk
20
Wk 
24
Wk
28
Wk 
32
Wk 
36
Wk
40
Wk 
44
Wk
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 /
End of 
Treatment
--or--
Early 
Termination 
Visit
4-Week
Post-
Treatment 
Follow-Up 
Visit t
Visit Window
Within -
30days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(+7days)
Written Informed 
Consent
X
Review 
Inclusion/Exclusion 
X
Medical History 
X
Complete/
Symptom Driven 
Physical 
Examinationa
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Vital Signsb
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
12 lead ECG
X
TB Test and Chest 
X rayc,d
X
Hematologyd
Xv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemistryd
Xv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Lipid Profile 
(Fasting)e
X
X
X
ANA Testf
X
Syphilis Testd,g
X
Serology Testingh
Xv


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Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
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Screening
Day1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk
12
Wk
16
Wk
20
Wk 
24
Wk
28
Wk 
32
Wk 
36
Wk
40
Wk 
44
Wk
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 /
End of 
Treatment
--or--
Early 
Termination 
Visit
4-Week
Post-
Treatment 
Follow-Up 
Visit t
Visit Window
Within -
30days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(+7days)
HBV Viral 
Monitoringh
X
X
X
X
X
Urine drug testi
Xv
Urinalysisd
Xv
X
X
X
X
X
Urine or Serum 
Pregnancy Testj
Xv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum FSHk
Xv
PKm
X
X
X 
X 
X 
X
X
Best Corrected 
Visual Acuity 
Testing (BCVA)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Slit Lamp Exam
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Tonometry
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CCI
CCI
CCI
CCI
CCI


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Protocol GS–US-432-4097
Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
Page 97
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Screening
Day1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk
12
Wk
16
Wk
20
Wk 
24
Wk
28
Wk 
32
Wk 
36
Wk
40
Wk 
44
Wk
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 /
End of 
Treatment
--or--
Early 
Termination 
Visit
4-Week
Post-
Treatment 
Follow-Up 
Visit t
Visit Window
Within -
30days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(+7days)
Dilated Indirect 
Ophthalmoscopy
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Fundus Color 
Photography (both 
eyes) 
X
X
X
Fluorescein 
Angiogram (both 
eyes)
X
X
X
Optical Coherence 
Tomography (OCT) 
Scan (both eyes)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Prior and Current 
Uveitis Medication
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
In Clinic Study 
Drug Dosingr
X
X
X
X
Study Drug 
Dispensationr
X
X
X
X
X
X
X
X
X
X
X
X
X
Prednisone 
Dispensations
X
X
X
CCI
CCI


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Protocol GS–US-432-4097
Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
Page 98
17 March 2020
Screening
Day1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk
12
Wk
16
Wk
20
Wk 
24
Wk
28
Wk 
32
Wk 
36
Wk
40
Wk 
44
Wk
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 /
End of 
Treatment
--or--
Early 
Termination 
Visit
4-Week
Post-
Treatment 
Follow-Up 
Visit t
Visit Window
Within -
30days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(±3
days)
(+7days)
Drug 
Accountability
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Con Meds
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
a
Complete PE will be performed at Screening and Week 52 or ET/EOT. Symptom driven PE will be performed at all other visits.
b
Vital signs include resting blood pressure, pulse, and temperature. 
c
Subjects must have the QuantiFERON® TB Gold In Tube test AND a chest radiograph (views as per local guidelines) taken at screening or within 3 months prior to screening 
(with the report or films available for investigator review). Subjects with evidence of a negative QuantiFERON® TB Gold In Tube test result within 3 months will not require 
a re test at Screening. QuantiFERON® TB Gold can be processed locally.
d
The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the central lab. For Chemistry panel, Uric acid to be tested 
at screening only per Appendix 6. Refer to list provided in Laboratory assessment table (Appendix 6).
e
Fasting lipid on Day 1 and Week 24. Week 52/EOT or ET visit lipid can be obtained fasting or non fasting.
f
Study personnel will collect a sample for antinuclear (ANA) and reflex double stranded DNA antibody testing at the Day 1/Baseline visit. A repeat ANA/Anti ds DNA
would be warranted if a subject has clinical signs and symptoms suggestive of lupus. The Anti ds DNA antibody testing will be performed in case of positive ANA result.
g
Subjects whom underwent syphilis screening (either a FTA test or a syphilis IgG test) for standard of care purposes within 3 months prior to Screening and evidence of a 
nonreactive FTA or syphilis IgG test result will not require a re test at Screening.
h
HBsAg and core Ab (if positive core Ab, then reflex HBV DNA and ongoing monitoring as applicable per Section 6.3.6), Hepatitis C Ab, (if positive then, reflex HCV RNA), 
HIV 1/2 antigen/antibody combination test (4th generation, as per Appendix 6). The required screening labs can be obtained either using the sites local lab or by submitting 
appropriate samples to the central lab. Subjects with positive HBV core Ab, and negative HBV DNA are eligible per investigator judgment, but may require prophylactic
treatment in accordance with HBV treatment guidelines/local standard of care and require ongoing monitoring with blood tests for HBV DNA every 3 months.
i
Drug screen to be conducted at screening only per Appendix 6. The required screening labs can be obtained either using the sites local lab or by submitting appropriate 
samples to the central lab.
j
Females of childbearing potential only. Serum pregnancy test at Screening and Urine pregnancy test to be conducted every 4 weeks during the dosing period through 35 days 
after their last dose of study drug. The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the central lab.
k
For female subjects <54 and amenorrhea ≥12 months. The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the 
central lab.
 
m
Day 1/Baseline and Week 12 PK sample to be drawn at least 30 minutes post dose. Week 4 and/or 6, PK sample to be drawn within 2 hours prior to dose. Weeks 24, 36 & 
52/EOT or ET PK can be drawn at any time. 
 
CCI
CCI


Filgotinib 
Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
I 
I 
I 
r 
tu y mg w1 
e 1spense to su ~ects every wee s untt 
ee 
or pnor to t e 
stu y vlSlt. 
Final 
Amendment4 
s 
Prednisone will be dispensed to subjects at Day I/Baseline (Dose strengths 20 mg and IO mg), Week 6 (Dose strengths 5 mg and 2.5 mg) and Week 8 (Dose strength I mg). 
t 
4 Week Post Treat111ent Follow Up Visit to be completed at the end of the Randomized Double Masked study. 
u 
Ifa subject presents at a site for an Unscheduled visit with symptoms related to a uveitis flare, subjects should be evaluated for treat111ent failure criteria. Iftreat111ent failure 
criteria are met, investigators should complete EOT procedures. If a subject presents at a site for an Unscheduled visit not related to a uveitis flare, investigators should 
complete unscheduled visit procedures at their discretion. 
v 
Tests obtained for standard of care purposes within 30 days of Day I/Baseline may be used to satisfy eligibility criteria. Refer to list provided in Laboratory assessment table 
(Appendix 6). 
CONFIDENTIAL 
Page 99 
17 March 2020 


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Protocol GS–US-432-4097
Final
Gilead Sciences, Inc. 
Amendment 4
CONFIDENTIAL
Page 100
17 March 2020
Appendix 3.
Management of Clinical and Laboratory Adverse Events
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Filgotinib 
Protocol GS-US-432-4097 
Final 
Gilead Sciences, Inc. 
Amendment 4 
Appendix 4. 
GSI Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities 
CTCAE v4.03 can be accessed from the below link: 
http://www.hrc.govt.nz/sites/default/files/CTCAE%20manual%20-%20DMCC.pdf 
The only modification to the CTCAE criteria is the addition of a Grade 1 upper respiratory 
infection as follows: 
CTCAE 
CTCAE v4.03 
v4.0 
AE Term 
Term 
Grade I 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
Definition 
IV antibiotic, 
A disorder 
M ild 
Moderate 
antifungal, 
characterized by 
symptoms; 
or antiviral 
Life-threatening 
an infectious 
symptoms; 
oral 
intervention 
process involving 
Upper 
symptomatic 
intervention 
indicated; 
consequences; 
the upper 
respiratory 
relief 
urgent 
Death 
infection 
(eg, cough 
indicated 
radiologic, 
intervention 
respiratory tract 
suppressant, 
( eg, antibiotic, 
endoscopic, 
indicated 
(nose, paranasal 
decongestant) 
anti fungal, 
or operative 
sinuses, pharynx, 
antiviral) 
intervention 
larynx, 
indicated 
or trachea). 
CONFIDENTIAL 
Page IOI 
17 March 2020 


Filgotinib 
Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
Final 
Amendment4 
Appendix 5. 
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements 
The administration of filgotinib in embryo-fetal animal development studies resulted in 
decreased numbers of viable rat fetuses, increased resorptions, and visceral and skeletal 
malfonnations. Similar effects were noted in the rabbit. A safety margin relative to human 
exposure has not been identified. Therefore, filgotinib is contraindicated during pregnancy. 
For participation in this study, the use of highly effective contraception is required as outlined 
below for all subjects of childbearing potential. In addition, women of childbearing potential 
should have a urine pregnancy test every 4 weeks during the study. 
1. 
Definitions 
a) 
Definition of Childbearing Potential 
For the purposes of this study, a female born subject is considered of childbearing potential 
following the initiation of puberty (Taimer stage 2) m1til becoming post-menopausal, 
unless pennanently sterile or with medically documented ovarian failure. 
Women are considered to be in a postmenopausal state when they are~ 54 years of age with 
cessation of previously occurring menses for~ 12 months without an alternative cause. 
In addition, women <54 with amenorrhea of~ 12 months may also be considered 
postmenopausal if their follicle stimulating honnone (FSH) level is in the postmenopausal range 
and they are not using honnonal contraception or honnonal replacement therapy. 
Pennanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female subject of any age. 
b) 
Definition of Male Fertility 
For the purposes of this study, a male born subject is considered of fertile after the initiation of 
puberty m1less pennanently sterile by bilateral orchiectomy or medical docmnentation of 
pennanent male infertility. 
2. 
Contraception for Female Subjects 
a) 
Study Drug Effects on Pregnancy and Hormonal Contraception 
Filgotinib is contraindicated in pregnancy as there is a possibility of hmnan 
teratogenicity/fetotoxicity in early pregnai1cy based on non-clinical data. Data from a drug-drug 
interaction study offilgotinib and honnonal contraceptives (GS-US-417-3916) demonstrated that 
filgotinib does not alter the phannacokinetics of representative honnonal contraceptives 
levonorgestrel/ethinyl estradiol. Results from this study may be fom1d in the Investigator's 
Brochure (Section 4.1.3.2.4). 
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Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
Final 
Amendment4 
For female subjects, honnonal contraceptives will be pennitted as a fonn of contraception when 
used in conjunction with a barrier method (preferably a male condom). For male subjects, male 
condom should be used; for their female partners of childbearing potential, an accepted 
contraceptive method should also be considered. Details are outlined below. 
Please refer to the latest version of the filgotinib 1B for additional infonnation. 
b) 
Contraception for Female Subjects of Childbearing Potential 
The inclusion of female subjects of childbearing potential requires the use of highly effective 
contraceptive measures. Women must have a negative serum pregnancy test at screening and a 
negative urine pregnancy test on the Day 1/Baseline visit prior to rando1nization. Pregnancy tests 
will be perfonned at monthly intervals thereafter. In the event of a delayed menstrual period 
(> one month between menstruations), a pregnancy test must be perfonned to rule out pregnancy. 
This is true even for women of childbearing potential with infrequent or irregular periods. 
Female subjects must agree to use one of the following methods from screening until 35 days 
following the last dose of study drug. 
• 
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the subject's preferred and usual 
lifestyle. 
Or 
• 
Consistent and correct use of 1 of the following methods of birth control listed below. 
Intrauterine device (IUD) with a failure rate of< 1 % per year 
Tubal sterilization 
Essure 1nicro-insert system (provided confinnation of success 3 months after procedure) 
Vasectomy in the male partner (provided that the partner is the sole sexual partner and 
had confinnation of surgical success 3 months after procedure, with documentation of 
spenn-free ejaculate) 
These above described methods are considered preferred methods of highly effective 
contraception in this protocol. 
Female subjects, who wish to use a honnonally based method, must use it in conjm1ction with a 
barrier method; the barrier method is to be used either by the female subject or by her male 
partner. Female subjects who utilize a honnonal contraceptive as one of their birth control 
methods must have consistently used the same method for at least three months prior to study 
dosing. Honnonally-based contraceptives and barrier methods pennitted for use in this protocol 
are as follows: 
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Filgotinib 
Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
Final 
Amendment4 
• 
Honn onal methods ( each method must be used with a barrier method, preferably male 
condom ) 
Oral contraceptives ( either combined estrogen/progestin or progesterone only) 
Injectable progesterone 
Implants of levonorgestrel 
Transdenn al contraceptive patch 
Contraceptive vaginal ring 
• 
Barrier methods ( each method must be used with a honn onal method) 
Male or female condom with or without spennicide 
Diaphragm with spennicide 
Cervical cap with spennicide 
Sponge with spennicide 
All female subjects must also refrain from egg donation and in vitro fertilization during study 
participation and until at least 35 days after the last study drug dose. 
3. 
Contraception Requirements for Male Subjects 
It is theoretically possible that a relevant syste1nic concentration may be achieved in a female 
partner from exposure to the male subject's se1ninal fluid. Therefore, male subjects with female 
partners of childbearing potential must use condoms during study participation and for 90 days 
after the last study drug dose. Female partners of male study subjects should consider using one 
of the above methods of contraception as well. Male subjects must also refrain from spenn 
donation during treatment and until at least 90 days after the end of dosing. 
4. 
Unacceptable Birth Control Methods 
Birth control methods that are unacceptable include periodic abstinence ( eg, calendar, ovulation, 
symptothenn al, post-ovulation methods), withdrawal (coitus interruptus), spennicides only, and 
lactational amenorrhea method (LAM). Female condom and male condom should not be used 
together. 
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Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
5. 
Procedures to be Followed in the Event of Pregnancy 
Final 
Amendment4 
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 35 days of last study drug dose. Subjects who 
become pregnant or who suspect that they are pregnant during the study must report the 
infonnation to the investigator and discontinue study drug i1mnediately. Subjects whose partner 
has become pregnant or suspects she is pregnant during the study are to report the infonnation to 
the investigator. 
Instructions for reporting pregnancy, partner pregnancy, and pregnancy outcome are outlined in 
Section 7.7.2.1. 
6. 
Pregnancy Testing 
All females of childbearing potential will have urine pregnancy testing every 4 weeks during the 
dosing period through 35 days after their last dose of study drug. If a positive urine pregnancy 
test is reported, the subject will be asked to return to the clinic for a confinnatory serum 
pregnancy test. 
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Protocol GS-US-432-4097 
Final 
Gilead Sciences, Inc. 
Amendment 4 
Appendix 6. 
Clinical Laboratory Assessment Table 
Hematology 
Chemistry 
Urinalysis 
Other 
Hematocrit 
Alkaline phosphatase 
Appearance: 
Urine drug screen 
Hemoglobin 
Aspartate aminotransferase 
Blood 
(screening) for: 
Platelet count 
(AST) 
Color 
Amphetamines 
Red blood cell (RBC) 
Alanine aminotransferase 
Glucose 
Cocaine 
count 
(ALT) 
Specific gravity 
Methadone 
White blood cell 
Nitrites 
Opiates 
(WBC) count 
Gamma-glutamyl 
Leukocyte esterase 
Quanti FERON® TB - Gold 
Differentials (absolute 
transpeptidase (GGT) 
pH 
In-Tube Analysis 
and percentage), 
Total bilirubin 
Protein 
including: 
Direct and indirect bilirubin Urobilinogen 
Antinuclear antibody 
(ANA) test and 
Lymphocytes 
Total protein 
Reflex to microscopic 
Anti-ds-DNA reflex in case 
Monocytes 
Albumin 
urinalysis if dipstick result is of positive ANA result 
Neutrophils 
abnormal 
(Day I/Baseline) 
Eosinophils 
Bicarbonate 
Basophils 
Blood urea nitrogen (BUN) 
Serology 
Syphilis Test (FTA or 
Reticulocyte count 
Calcium 
Hepatitis B surface antigen 
syphilis lgG test) 
Mean corpuscular 
Chloride 
(HBsAg) and core Ab, (if 
volume (MCV) 
Serum creatinine 
positive core Ab, then reflex 
Creatinine clearance 
HBV DNA) 
CC&G• 
Hepatitis C Ab (if positive, 
Glucose 
then reflex HCV RNA) 
Phosphorus 
HJ V 1/2 antigen/antibody 
combination test ( 4'h 
Magnesium 
generation) 
Potassium 
Pregnancy 
Sodium 
Amylase 
In .females of childbearing 
Lipase 
potential: 
Uric Acid (screening) 
Serum pregnancy 
Urine pregnancy 
Lipid Profi le (Fasting, if 
In.females of non 
applicable) 
triglycerides, cholesterol 
childbearing potential: 
Follicle Stimulating 
and its subfractions (high-
Hormone (FSH) Test 
density lipoprotein (HDL] 
and low-density lipoprotein 
(LDL]) 
Creatine Phosphokinase 
(CPK) 
a 
Creatinine clearance is calculated by the Cockcroft Gault equation {Cockcroft 1976} using actual body weight (BW). 
Male: Cl er (mL/min) 
(1 40 age (years)) x BW(kg) 
72 x Ser 
Female: Cl er (ml/min) 
( 140 age (years)) x BW(kg) x 0.85 
72 x Ser 
Ser 
semm creatinine (mg/dL) 
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Filgotinib 
Protocol GS-US-432-4097 
Final 
Gilead Sciences, Inc. 
Amendment 4 
Appendix 7. 
Corticosteroid Conversion Table 
Prednisone 
Substance Names 
Selection of Trade Names 
Equivalents 5 mg 
Alphatrex, Betacord, Betaderm, Betatrex, Beta-Val 
Betamethasone 
Betnelan, Betamethasone Dipropionate, 
0.75 mg 
Celestone/Alphatrex, Diprolene AF, Diprosone, 
Maxivate, Teladar/Diprolene, Celestan, Betnesol 
Cloprednole 
Synthesan 
2.5 mg 
Cortisone 
Cortison CIBA, Cortone Acetate 
25 mg 
Detlazacort 
Calcort 
6 mg 
Aeroseb-Dex, Dalalone, Decadron Phosphate, Dexacen 
Dexamethasone 
LA-8, Dexacen-4, Dexasone, Dexone, Hexadrol 
0.75 mg 
Phosphate, Solurex, Decadron, Fortecortin, Auxiloson, 
Milicorten 
Fluocortolone 
Ultralan 
5 mg 
Hydrocortisone 
Cortef, Cortenema, Hydrocortisone, Solu-Cortef, 
20 mg 
Hydrocortison Hoechst 
Methylprednisolone 
Medrol/Depo-Medrol, Duralone, Medralone, Rep-Pred/ 
4 mg 
A-Methapred, Solu-Medrol, Medrate Urbason 
Paramethasone 
Monocortin 
2 mg 
Delta-Cortef, Hydeltrasol, Hydeltra-TBA, Key-Pred 25, 
Prednisolone 
Predalone 50, Predcor-25, Prelone, Solu Decortin-H, 
5 mg 
Detacortril, Hostacortin-H, Ultracorten-H, Scherisolon 
Apo-Prednisone, Deltasone, Meticorten, Orasone, 
Prednisone 
Panasol-S, Prednicen-M, Sterapred, Winpred, Decortin, 
5 mg 
Hostacortin 
Prednylidene 
Decortilen 
6 mg 
Amcort, Aristocort, Atolone, Azmacort, Cenocort A-40, 
Triamcinolone 
Cenocort Forte, Kemocort, Kenalog, Tac-40, Triam-A, 
4 mg 
Triamcinolone, Triam Forte, Triamolone, Tri-kort, Trilog, 
Trilone, Delphicort, Extracort, Tram-oral, Yalon 
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Protocol GS-US-432-4097 
Gilead Sciences, Inc. 
Appendix 8. 
AREDS 2008 Clinical Lens Opacity Grading Procedures 
AREDS Study Group 
• 
Dilate pupils to at least 5 1mn diameter 
• 
Use slit lamp with~ 1 Ox magnification 
• 
Use brightest beam intensity 
• 
Nuclear opacity 
Orient beam at 45° to viewing axis 
Adjust slit beam to standard parameters: 8 1mn height and 0.3 1mn width 
Compare opalescence of nucleus with that in standard photos 
• 
Cortical and PSC opacities 
Select wide slit beam setting optimum for retro-illumination of lens 
Visualize lens opacities against red fundus reflex background 
Count only opacities definitely visible against red reflex 
Mentally combine all cortical opacities into one contiguous area 
Compare total opacity area with that in standard photos 
• 
Classify each opacity with scale defined by 3 standard photos 
• 
Select nearest half-step 
Similar to standard or between two standards 
Obviously less than mildest standard or greater than most severe 
CONFIDENTIAL 
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Final 
Amendment4 
17 March 2020 

SAP_001.pdf: 
Study Title: 
Name of Test Drug: 
Study Number: 
Protocol Version (Date): 
Analysis Type: 
Analysis Plan Version: 
Analysis Plan Date: 
Analysis Plan Author(s): 
(r} GILEAU 
STATISTICAL ANALYSIS PLAN 
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating 
the Efficacy and Safety of Filgotinib in Subjects with Active 
Noninfectious Uveitis 
Filgotinib 
GS-US-432-4097 
Amendment 4: 
17 March 2020 
Final Analysis 
Version 1.0 
06 October 2021 
PPD 
CONFIDENTIAL AND PROPRIETARY INFORMATION 


Filgotinib 
GS-US-432-4097
Statistical Analysis Plan – Final Analysis
Version 1.0 
CONFIDENTIAL
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06 October 2021
TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................4
LIST OF IN-TEXT FIGURES........................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
1.
INTRODUCTION..................................................................................................................................................7
1.1.
Study Objectives........................................................................................................................................7
1.2.
Study Design .............................................................................................................................................8
1.3.
Sample Size and Power ...........................................................................................................................10
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................11
2.1.
Interim Analyses......................................................................................................................................11
2.2.
Final Analysis..........................................................................................................................................11
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................12
3.1.
Analysis Sets ...........................................................................................................................................12
3.1.1.
All Randomized Analysis Set................................................................................................12
3.1.2.
Full Analysis Set....................................................................................................................12
3.1.3.
Evaluable Analysis Set..........................................................................................................12
3.1.4.
Safety Analysis Set................................................................................................................12
3.2.
Subject Grouping.....................................................................................................................................13
3.3.
Strata and Covariates...............................................................................................................................13
3.4.
Examination of Subject Subgroups .........................................................................................................14
3.5.
Multiple Comparison...............................................................................................................................14
3.6.
Missing Data and Outliers.......................................................................................................................14
3.6.1.
Missing Data..........................................................................................................................14
3.6.2.
Outliers ..................................................................................................................................14
3.7.
Data Handling Conventions and Transformations ..................................................................................14
3.8.
Analysis Visit Windows..........................................................................................................................15
3.8.1.
Definition of Study Day ........................................................................................................15
3.8.2.
Analysis Visit Windows........................................................................................................15
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................17
4.
SUBJECT DISPOSITION ...................................................................................................................................19
4.1.
Subject Enrollment and Disposition........................................................................................................19
4.2.
Extent of Study Drug Exposure and Adherence......................................................................................20
4.2.1.
Duration of Exposure to Study Drug.....................................................................................20
4.2.2.
Adherence to Study Drug ......................................................................................................21
4.3.
Protocol Deviations .................................................................................................................................22
4.4.
Assessment of COVID-19 Impact...........................................................................................................22
4.4.1.
Study Drug or Study Discontinuation Due to COVID-19.....................................................22
4.4.2.
Protocol Deviations Due to COVID-19 ................................................................................22
4.4.3.
Missed and Virtual Visits due to COVID-19 ........................................................................23
4.4.4.
Adverse Events Due to COVID-19 .......................................................................................23
4.4.5.
Overall Assessment of COVID-19 Pandemic Impact...........................................................23
5.
BASELINE CHARACTERISTICS .....................................................................................................................25
5.1.
Demographics and Baseline Characteristics ...........................................................................................25


Filgotinib 
GS-US-432-4097 
Statistical Analysis Plan - Final Analysis 
Version 1.0 
5.2. 
Other Baseline Disesase Characteristics ................................................................................................. 25 
5.3. 
Medical Histoiy ....................................................................................................................................... 29 
6. 
EFFICACY ANALYSES ..................................................................................................................................... 30 
6.1. 
General Consideration ............................................................................................................................. 30 
6.2. 
Pri1nruy Efficacy Endpoint ...................................................................................................................... 30 
6.2.1. 
Definition of the Prima1y Efficacy Endpoint ........................................................................ 30 
6.2.2. 
Primruy Analysis of the Prima1y Efficacy Endpoint ............................................................. 30 
6.2.3. 
Sensitivity Analysis of the Primruy Endpoint ...................................................................... .31 
6.2.4. 
Subgroup Analysis of the Prima1y Endpoint ......................................................................... 31 
6.3. 
Secondruy Efficacy Endpoints ................................................................................................................ 31 
6.3.1. 
Definition of Seconda1y Efficacy Endpoints ......................................................................... 32 
6.3.2. 
Analysis Methods for Seconda1y Efficacy Endpoints ........................................................... 34 
6.3.3. 
Sensitivity Analysis for Key Seconda1y Efficacy Endpoints ............................................... .35 
Sub ·ou Anal sis of the Ke Seconda1 End oints ............................................................ 35 
6.5. 
Changes From Protocol-Specified Efficacy Analyses ............................................................................ 38 
7. 
SAFETY ANALYSES ......................................................................................................................................... 39 
7 .1. 
Adverse Events and Deaths ..................................................................................................................... 39 
7.1. 1. 
Adverse Event Dictiona1y ..................................................................................................... 39 
7.1.2. 
Adverse Event Severity ......................................................................................................... 39 
7.1.3. 
Relationship of Adverse Events to Study Dmg ..................................................................... 39 
7.1.4. 
Serious Adverse Events ......................................................................................................... 39 
7.1.5. 
Treatinent-Emergent Adverse Events .................................................................................... 39 
7.1.6. 
Summaries of Adverse Events and Deaths ........................................................................... .40 
7. 1. 7. 
Adverse Events of Interest. ................................................................................................... .42 
7 .2. 
Laborato1y Evaluations ........................................................................................................................... 44 
7.2.1. 
Summaries of Numeric Laborat01y Results .......................................................................... 44 
7.2.2. 
Graded Laborato1y Value ...................................................................................................... 44 
7.2.3. 
Liver-related Laborat01y Evaluations ................................................................................... .46 
7 .3. 
Body Weight and Vital Signs ................................................................................................................. .46 
7.4. 
Prior and Concoinitant Medications ....................................................................................................... .47 
7.4.1. 
Prior Medications ................................................................................................................. .47 
7.4.2. 
Conco1nitant Medications ..................................................................................................... .47 
7.5. 
Electrocru·diogra1n Results ...................................................................................................................... .48 
7 .5. 1. 
Investigator Electi·ocardiogram Assessment ........................................................................ .48 
7 .6. 
Other Safety Measures ........................................................................................................................... .48 
7.7. 
Changes From Protocol-Specified Safety Analyses ............................................................................... .48 
8. 
PHARMA CO KINETIC ANALYSES ................................................................................................................. .49 
I 
10. REFERENCES ..................................................................................................................................................... 51 
11. SOFTWARE ......................................................................................................................................................... 52 
12. SAP REVISION ................................................................................................................................................... 53 
13. APPENDICES ...................................................................................................................................................... 54 
Appendix 1. 
Appendix 2. 
Appendix 3. 
CONFIDENTIAL 
Corticosteroids Dose Conversion Chait ................................................................................ 54 
Study Procedures Table ......................................................................................................... 55 
Data Collection of COVID-19 Data ...................................................................................... 60 
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Sample SAS Code for Analysis ofBina1y Endpoints ........................................................... 61 
Sam le SAS Code for Anal sis of Time to Event End oints ............................................... 62 
LIST OF IN-TEXT TABLES 
Table 1-1. --
Table 6-2. 
Vitreous Haze .......................................................................................................................... 33 
Table 13-1. 
Examples Search Tenns for "COVID-19" and "Viitual" Used to Identify 
Missed/Viitual Visits ............................................................................................................... 60 
LIST OF IN-TEXT FIGURES 
Figure I.I. 
Study Schema ............................................................................................................................ 9 
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Statistical Analysis Plan – Final Analysis
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LIST OF ABBREVIATIONS
AC
Anterior chamber
AE
adverse event
AESIs
adverse events of special interest
ALT
alanine aminotransferase
ANCOVA
analysis of covariance
AST
aspartate aminotransferase
ATC
Anatomical Therapeutic Chemical drug class
BCVA
best corrected visual acuity
BLQ
below the limit of quantitation
BMI
body mass index
CI
confidence interval
CMH
Cochran-Mantel-Haenszel
CRF
case report form
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
DMC
data monitoring committee
ECG
electrocardiogram
eCRF
electroni case report form
ET
early termination
FAS
full analysis set
FDA
Food and Drug Administration
Gilead
Gilead Sciences, Inc.
HLGT
high-level group term
HLT
high-level term
ID
identification
IWRS
interactive web response system
LLOQ
lower limit of quantitation
LLT
lower-level term
logMAR
logarithm of the minimal angle of resolution
LOQ
limit of quantitation
MedDRA
Medical Dictionary for Regulatory Activities
NEI/SUN
National Eye Institute/Standardization of Uveitis Nomenclature
OCT
optical coherence tomography
PD
pharmacodynamics 
PK
pharmacokinetic
PT
preferred term
PTM
Placebo to match
CCI-


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06 October 2021
Q1, Q3
first quartile, third quartile
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SE
standard error
SMQ
standardised MedDRA queries
SOC
system organ class
TEAE
treatment-emergent adverse event
TFLs
tables, figures, and listings
ULN
upper limit of normal
US
United States
VH
vitreous haze
WHO
World Health Organization
CCI
CCI
CCI
1111 
-
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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and data 
presentations to be used in tables, figures, and listings (TFLs) in the clinical study report (CSR) 
for Study GS-US-432-4097. This SAP is based on the study protocol dated 17 March 2020 and 
the electronic case report form (eCRF). The SAP will be finalized before database finalization. 
Any changes made after the finalization of the SAP will be documented in the CSR.
1.1.
Study Objectives
The primary objective of this study is as follows:

To evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and 
symptoms of noninfectious uveitis as measured by the proportion of subjects failing 
treatment for active noninfectious uveitis by Week 24   
The secondary objectives of this study are as follows:

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the time to treatment failure on or after Week 6

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in vitreous haze (VH) grade in each eye (National Eye 
Institute/Standardization of Uveitis Nomenclature [NEI/SUN] criteria), from best state 
achieved prior to Week 6 to Week 52/ End of Treatment (EOT) visit or Early Termination 
(ET) visit

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in anterior chamber (AC) cell grade in each eye, from best state 
achieved prior to Week 6 to Week 52/ EOT visit or ET visit

To evaluate the effects of filgotinib versus placebo as measured by the 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/EOT visit or ET visit

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the change in central retinal thickness in each eye, from best state achieved 
prior to Week 6 to Week 52/ EOT visit or ET visit

To evaluate the efficacy of filgotinib versus placebo for the treatment of noninfectious uveitis 
as measured by the time to development of macular edema in at least one eye as determined 
by optical coherence tomography (OCT) on or after Week 6

To evaluate the safety and tolerability of filgotinib

To evaluate the pharmacokinetics of filgotinib and its metabolite GS-829845


Filgotinib 
GS-US-432-4097 
Statistical Analysis Plan - Final Analysis 
I 
I 
I 
I 
I 
I 
I 
1.2. 
Study Design 
Version 1.0 
This is a randomized, double-masked, placebo-controlled Phase 2 trial in adult subjects with 
active noninfectious inte1mediate-, posterior-, or pan-uveitis in at least one eye despite at least 
2 weeks of maintenance therapy with oral prednisone at a dose of ~ 10 mg/day to ~ 60 mg/day 
(or oral c01iicosteroid equivalent, conversion chaii is in Appendix 1). The study is designed to 
demonstrate the efficacy and safety of filgotinib in adult subjects requiring high dose steroids for 
active noninfectious inte1mediate-, posterior-, or pan-uveitis. Both of the subject's eyes as 
applicable should be evaluated for the purpose of detennining eligibility based on inclusion and 
exclusion criteria, and for the purpose of assessing treatment failure. There will be no designated 
"study eye". 
Subjects will be randomized in a 1: 1 ratio to receive filgotinib 200 mg once daily or placebo to 
match (PTM) for up to 52 weeks, as shown in Figure 1.1. Subjects that meet criteria for 
treatment failure or discontinue for any other reason prior to the end of the study will have an 
EOT or ET visit (as appropriate). 
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It is anticipated that approximately 25% of subjects will have their uveitis attributed to 
sarcoidosis. Subjects will be stratified according to whether their uveitis is attributed to 
sarcoidosis (yes/no), baseline use of immunosuppressant(s) (yes/no), and prior use of anti-TNF 
therapy (yes/no). All subjects will be administered 60 mg/day of oral prednisone at 
Day 1/Baseline followed by a protocol-defined mandatory taper schedule in which all subjects 
continuing in the study will discontinue prednisone no later than Week 15. Subjects who enter 
the study on topical ocular corticosteroids will undergo a standardized taper schedule until they 
have completely discontinued topical ocular corticosteroids no later than Week 9. Depending on 
the topical ocular corticosteroid dose that the subject is on at the baseline visit, the number of 
drops per day will be decreased every week according to a predefined schedule.
Figure 1.1.
Study Schema
The schedule of assessments is provided as an appendix to this analysis plan (Appendix 2). 
Beginning at Week 6 and at all subsequent visits, subjects will be examined for evidence of 
treatment failure. Treatment failure will be defined as a subject meeting at least one of the 
elements of failure criteria in at least 1 eye as outlined in Table 1-1.
DAYl 
WK 6 
WK 15 
WK24 
Screening 
Within 30 days of 
l : 1 
BJseline/Day 1, 
must have active 
uveitis despite ;>c 2 wks 
of oral corticosteroids 
Primary IEMpofflt 
I 
N=124, Filgotinib (200mg) 
N=124, Placebo 
WK52 


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Table 1-1.
Treatment Failure Criteria
Treatment Failure *
Parameter
Week 6 Visit
All Visits After Week 6
Inflammatory chorioretinal and/or 
inflammatory retinal vascular lesions
New active, inflammatory lesions 
relative to Day 1/Baseline
New active, inflammatory lesions 
relative to Day 1/Baseline
Anterior Chamber Cell grade 
(SUN Criteria)
Inability to achieve ≤ Grade 0.5+
2-step increase relative to best 
state achieved **
Vitreous Haze grade 
(NEI/SUN Criteria)
Inability to achieve ≤ Grade 0.5+
2-step increase relative to best 
state achieved **
Visual Acuity Early Treatment 
Diabetic Retinopathy Study 
(ETDRS)
Worsening of BCVA by ≥ 15 
letters relative to best state 
achieved
Worsening of BCVA by 
≥ 15 letters relative to best state 
achieved
* To be considered a treatment failure, ≥ 1 of these criteria need to be present in at least 1 eye. “Best state” refers to the best
measures recorded at all prior visits.
** A 2-step increase is represented by a change of Grade 0 to Grade 2+; or Grade 0.5+ to Grade 3+.
Subjects with evidence of treatment failure at or after Week 6 will be discontinued from study 
and treated at the discretion of the investigator.
1.3.
Sample Size and Power
Sample size calculations are based on published data from the VISUAL I trial {Jaffe 2016}.
Assuming the observed proportion of subjects failing treatment by Week 24 is 70% in the 
placebo group, 107 subjects per treatment group will provide at least 85% power to detect a 
reduction of 20% in the proportion of subjects with treatment failure by Week 24 in the filgotinib 
group using a 2-sided significance level of 0.05. Given an expected attrition rate of 15%, a total 
of 248 subjects will need to be randomized into the study. 
On 15 December 2020, Gilead decided to halt the study at an enrollment of 74 subjects despite 
the study not achieving complete enrollment of planned 248 subjects. The discontinuation of 
global development for filgotinib was a business decision and not because of any safety concerns 
with filgotinib or the study procedures.


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Interim Analyses
An external multidisciplinary Data Monitoring Committee (DMC) will review the progress of 
the study and perform interim reviews of the safety data in order to protect subject welfare and 
preserve study integrity. To ensure the best interests of the participants, the DMC will 
recommend to the sponsor if the nature, frequency, and severity of adverse effects associated 
with the study treatment warrant the early termination of the study, the continuation of the study, 
or the continuation of the study with modifications. 
The initial DMC safety data review meeting will be conducted after approximately 25% of 
enrolled subjects have either completed their Week 24 visit or discontinued from the study 
before Week 24. Following the initial data review meeting, further DMC reviews will be 
scheduled to occur after approximately 50% and 75% of enrolled subjects have either completed 
their Week 24 visit or discontinued from the study before Week 24.
There will be 1 planned interim analysis of efficacy and futility based upon the primary endpoint 
when approximately 50% of enrolled subjects have either completed their Week 24 visit or 
discontinued from the study before Week 24. The rejection boundary for efficacy will be based 
on a significance level of 0.001. A non-binding futility rule is defined as a predictive power 
(i.e., the probability of obtaining a statistically significant result at the final analysis given the 
observed interim data) being < 20%.
To control for the overall type I error rate at 0.05, an alpha of 0.001 will be spent for the 
filgotinib group comparison to the placebo group based on the Haybittle-Peto boundaries at the 
interim analysis. As a result, an adjusted 2-sided significance level of 0.0498 will be used to 
declare statistical significance for the final primary analysis.
If the DMC recommends early termination of the study, an internal Gilead team who are not 
involved with the study may perform an unmasked review of the interim data to decide the path 
forward. While the DMC will be asked to advise Gilead regarding future conduct of the study, 
including possible early study termination, Gilead retains final decision-making authority on all 
aspects of the study.
The DMC’s role and responsibilities and the scope of analysis to be provided to the DMC are 
provided in a mutually agreed upon charter, which defines the DMC membership, meeting 
logistics, and meeting frequency.
At the time of study early termination, two DMC safety data review meetings had taken place, 
but no interim analysis of efficacy and futility were performed.
2.2.
Final Analysis
After all subjects enrolled prior to study early termination have completed the study, outstanding 
data queries have been resolved or adjudicated as unresolvable, and the data have been cleaned 
and finalized, the final analysis of the data will be performed.


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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, 
the number and percentage of subjects in each category will be presented; for continuous 
variables, the number of subjects (n), mean, standard deviation (SD) or standard error (SE), 
median, first quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
By-subject listings will be presented for all subjects in the All Randomized Analysis Set and 
sorted by subject ID number, visit date, and time (if applicable). Data collected on log forms, 
such as AEs, will be presented in chronological order within the subject. The treatment group to 
which subjects were randomized will be used in the listings. Age, sex at birth, race, and ethnicity 
will be included in the listings.
3.1.
Analysis Sets
Analysis sets define the subjects to be included in an analysis. Analysis sets and their definitions 
are provided in this section. Subjects included in each analysis set will be determined before the 
study blind is broken for analysis. The analysis set will be identified and included as a subtitle of 
each table, figure, and listing (TFL).
For each analysis set, the number and percentage of subjects eligible for inclusion, as well as the 
number and percentage of subjects who were excluded and the reasons for their exclusion, 
will be summarized by treatment group.
A listing of reasons for exclusion from analysis sets will be provided by subject.
3.1.1.
All Randomized Analysis Set
All Randomized Analysis Set includes all subjects who are randomized in the study. This is the 
primary analysis set for by-subject listings.
3.1.2.
Full Analysis Set
The Full Analysis Set (FAS) includes all randomized subjects who received at least 1 dose of 
study drug. 
3.1.3.
Evaluable Analysis Set
The Evaluable Analysis Set is the primary analysis set for efficacy analyses which includes all 
randomized subjects who receive at least one dose of study drug, and do not permanently 
discontinue from the study prior to Week 6. 
3.1.4.
Safety Analysis Set
The Safety Analysis Set includes all subjects who received at least 1 dose of study drug. This is 
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3.2.
Subject Grouping
For analyses based on the All Randomized Analysis Set, Evaluable Analysis Set, and FAS, 
subjects will be grouped according to the treatment to which they were randomized. For analyses 
based on the Safety Analysis Set, subjects will be grouped according to actual treatment 
received. The actual treatment received will differ from the randomized treatment only when 
their actual treatment differs from randomized treatment for the entire treatment duration. In this 
case, the actual treatment received is defined as the treatment received for the entire treatment 
duration.
3.3.
Strata and Covariates
Subjects will be randomly assigned to treatment groups via the interactive web response system 
(IWRS) in a 1:1 ratio using a stratified randomization schedule. Stratification will be based on 
the following variables:

Uveitis is attributed to sarcoidosis (yes/no)

Baseline use of immunosuppressant (yes/no)

Prior use of anti-TNF therapy (yes/no)
If there are discrepancies in stratification factor values between the IWRS and the clinical 
database, the values recorded in the clinical database will be used for analyses. 
Efficacy endpoint will be evaluated using stratification factors as covariates or stratification 
variables for analyses, as specified in Section 6. If there are a small number of subjects 
(eg, < 5 subjects) within a stratum of a stratification factor, then the stratification factor will not 
be included as covariates or stratification variables for efficacy analysis. 
For efficacy endpoints, the baseline value of the efficacy variable(s) will be included as a 
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3.4.
Examination of Subject Subgroups
Subgrouping of subjects based on the following two stratification factors will be explored for 
subgroup analyses.

Uveitis is attributed to sarcoidosis (yes/no)

Baseline use of immunosuppressant (yes/no)
3.5.
Multiple Comparison
The number of enrolled subjects is much smaller than planned, due to early termination of the 
study. 
 The 
correspondingly reported p-values for all the comparisons planned in this SAP will be nominal, 
and need to be interpreted with caution.
3.6.
Missing Data and Outliers
3.6.1.
Missing Data
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this document.
For missing last dosing date of study drug, imputation rules are described in Section 4.2.1. The 
handling of missing or incomplete dates for AE onset is described in Section 7.1.5.2, and for 
prior and concomitant medications in Section 7.4.  Imputation rules adopted in the efficacy 
analyses are specified in Section 6.
3.6.2.
Outliers
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analyses.
3.7.
Data Handling Conventions and Transformations
The following conventions will be used for the imputation of date of birth when it is partially 
missing or not collected:

If only month and year of birth is collected, then “15” will be imputed as the day of birth

If only year of birth is collected, then “01 July” will be imputed as the day and month of birth

If year of birth is missing, then date of birth will not be imputed.
In general, age collected at Day 1 (in years) will be used for analyses and presented in listings. If 
age at Day 1 is not available for a subject, then age derived based on date of birth and the Day 1 
visit date will be used instead. If an enrolled subject was not dosed with any study drug, the 
randomization date will be used instead of the Day 1 visit date. For screen failures, the date the 
first informed consent was signed will be used for the age derivation. Age required for 
longitudinal and temporal calculations and analyses (e.g., estimates of creatinine clearance, age 
at date of AE) will be based on age derived from date of birth and the date of the measurement or 
event, unless otherwise specified.
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Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows:

A value that is 1 unit less than the lower LOQ at the same precision level of the originally 
reported value will be used to calculate descriptive statistics if the datum is reported in the 
form of “ x” (where x is considered the lower LOQ). For example, if the values are reported 
as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to calculate summary 
statistics. An exception to this rule is any value reported as < 1 or < 0.1, etc. For values 
reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be used for calculate 
summary statistics.

A value that is 1 unit above the upper LOQ will be used to calculate descriptive statistics if 
the datum is reported in the form of “> x” (where x is considered the upper LOQ). Values 
with decimal points will follow the same logic as above.

The lower or upper LOQ will be used to calculate descriptive statistics if the datum is 
reported in the form of “≤ x” or “≥ x” (where x is considered the lower or upper LOQ, 
respectively).
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data or nonparametric analysis methods may be used, 
as appropriate.
PK concentration values that are below the limit of quantitation (BLQ) will be presented as 
“BLQ” in the data listing.
3.8.
Analysis Visit Windows
3.8.1.
Definition of Study Day 
Study Day will be calculated from the the first dosing date of study drug and derived as follows:

For postdose study days: Assessment Date – First Dosing Date + 1

For days prior to the first dose: Assessment Date – First Dosing Date
Therefore, study day 1 is the day of first dose of study drug administration.
3.8.2.
Analysis Visit Windows
Subject visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows.
In general, the baseline value will be the last nonmissing value on or prior to the first dose date 
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The efficacy endpoints, vital signs, body weight, and safety laborato1y data collected during the 
'On-treatment' period will be mapped to the analysis visit window as specified below. The 
'On-treatment' period is defined as from Study Day 1 to the last dose date of any study 
dmg + 5 days. The on-treatment visit windows will be calculated from Study Day 1. 
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Efficacy data, vital signs, body weight, and safety laboratory collected in the post-treatment 
follow-up period will be summarized as a separate visit, and labeled “Follow-up Visit” and also 
be included in the listings. The analysis window for the post-treatment follow-up period is 
defined as from the last dose date of any study drug + 6 days to the last dose date of any study 
drug + 35 days. The analysis visit window won’t be applied to data collected after the last dose 
+ 35 days, and the data obtained will only be included in the listings with the nominal visit name 
displayed only.
When data are summarized by visit, the following visits will be summarized together in a 
separate visit labeled as “Week 52/EOT visit or ET visit ” visit.

Week 52 visit for subjects who complete study until Week 52 visit,

First treatment failure visit for subjects who have a treatment failure,

ET visit, or last available visit prior to study discontinuation when ET visit is not available, 
for subjects who prematurely discontinue from the study (early termination).
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window
Depending on the statistical analysis method, single values may be required for each analysis 
window. For example, change from baseline by visit usually requires a single value, whereas a 
time-to-event analysis would not require 1 value per analysis window.
If multiple valid, nonmissing, continuous measurements exist in an analysis window, 
records will be chosen based on the following rules if a single value is needed:

In general, the baseline value will be the last nonmissing value on or prior to the first dose 
date of study drug, unless otherwise specified. If multiple measurements occur on the same 
day, the last nonmissing value prior to the time of first dose of study drug will be considered 
as the baseline value. If these multiple measurements occur at the same time or the time is 
not available, the average of these measurements (for continuous data) will be considered the 
baseline value.

For postbaseline visits:
The record closest to the nominal day for that visit will be selected.
If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.
If there is more than 1 record on the selected day, the average will be taken, 
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If multiple valid, nonmissing, categorical measurements exist in an analysis window, 
records will be chosen based on the following rules if a single value is needed:

For baseline, the last available record on or prior to the date of the first dose of study drug 
will be selected. If there are multiple records with the same time or no time recorded on the 
same day, the value with the lowest severity will be selected (eg, normal will be selected over 
abnormal for safety ECG findings).

For postbaseline visits, if there are multiple records with the same time or no time recorded 
on the same day, the value with the worst severity within the window will be selected 
(eg, abnormal will be selected over normal for safety ECG findings).


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4.
SUBJECT DISPOSITION
4.1.
Subject Enrollment and Disposition
A summary of subject enrollment will be provided by treatment group for each country, 
investigator within a country, and overall. The summary will present the number and percentage 
of subjects enrolled. For each column, the denominator for the percentage calculation will be the 
total number of subjects analyzed for that column.
A similar enrollment table will be provided by randomization stratum. The denominator for the 
percentage of subjects in the stratum will be the total number of randomized subjects. If there are 
discrepancies in the value used for stratification assignment between the IWRS and the clinical 
database or other source documents, the value collected in the clinical database will be used for 
the summary. A listing of subjects with discrepancies in the value used for stratification 
assignment between the IWRS and the clinical database at the time of data finalization will be 
provided.
The randomization schedule used for the study will be provided as an appendix to the CSR.
A summary of subject disposition will be provided by treatment group. This summary will 
present the number of subjects screened, the number of subjects who met all eligibility criteria 
but were not randomized with reasons subjects were not randomized, the number of subjects 
randomized, and the number of subjects in each of the categories listed below:

Safety Analysis Set

Evaluable Analysis Set

Full Analysis Set

Completed study drug 

Did not complete study drug with reasons for premature discontinuation of study drug

Completed prednisone taper 

Did not complete Prednisone taper with reasons for discontinuation of prednisone taper

Completed study 

Did not complete study with reasons for premature discontinuation from the study
For the status of study drug and study completion and reasons for premature discontinuation, the 
number and percentage of subjects in each category will be provided. In addition, the status of 
prednisone taper completion and reasons for discontinuation will be provided. The denominator 


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for the percentage calculation will be the total number of subjects in the Safety Analysis Set 
corresponding to that column. 
The following by-subject listings will be provided by subject identification (ID) number in 
ascending order to support the above summary tables:

Reasons for premature study drug or study discontinuation

Reasons for premature prednisone taper discontinuation

Reasons for screen failure (will be provided by screening ID number in ascending order)

Lot number and bottle ID of assigned study drugs
4.2.
Extent of Study Drug Exposure and Adherence
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug and the level of adherence to the study drug specified in the protocol.
4.2.1.
Duration of Exposure to Study Drug
Total duration of exposure to any study drug will be defined as last dosing date minus first 
dosing date plus 1, regardless of any temporary interruptions in study drug administration, and 
will be expressed in weeks using up to 1 decimal place (eg, 4.5 weeks). If the last study drug 
dosing date is missing, the latest date among the study drug end date, clinical visit date, 
laboratory sample collection date, and vital signs assessment date that occurred during the 
on-treatment period will be used for subjects included in the final analyses. If month and year of 
the last dose are known, and the last study drug dosing date imputed above is different from the 
month collected, the last date of that month will be used. If only year of the last dose is known, 
and the last study drug dosing date imputed above is after the year collected, the last date of that 
year will be used; if the last study drug dosing date imputed above is before the year collected, 
the first date of that year will be used.
The total duration of exposure to study drug will be summarized using descriptive statistics and 
using the number (ie, cumulative counts) and percentage of subjects exposed through the 
following time periods: Baseline (Day 1), Week 1 (Day 8), Week 4 (Day 29), Week 6 (Day 43), 
Week 8 (Day 57), Week 12 (Day 85), Week 16 (Day 113), Week 20 (Day 141), Week 24 
(Day 169), Week 28 (Day 197), Week 32 (Day 225), Week 36 (Day 253), Week 40 (Day 281), 
Week 44 (Day 309), Week 48 (Day 337), and Week 52 (Day 365). 


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The total duration of exposure to prednisone will also be summarized using descriptive statistics 
and using the number and percentage of subjects exposed through the following time periods: 
Baseline (Day 1), Week 1 (Day 8), Week 4 (Day 29), Week 6 (Day 43), Week 8 (Day 57), 
Week 12 (Day 85), and Week 15 (Day 106).
Summaries will be provided by treatment group for the Safety Analysis Set. No formal statistical 
testing is planned.
4.2.2.
Adherence to Study Drug
The total number of tablets administered will be summarized using descriptive statistics. 
The presumed total number of tablets administered to a subject will be determined by the data 
collected on the drug accountability eCRF using the following formula:
Total Number of Tablets Administered =
No. of Tablets Dispensed ―
No. of Tablets Returned
If a bottle is dispensed and the bottle is returned empty, then the number of tablets returned will 
be entered as zero. If a bottle is dispensed but not returned (missing), the number of tablets 
returned will be counted as zero. On-treatment adherence will be calculated to assess the level of 
adherence to study drugs.
The level of on-treatment adherence to the study drug will be determined by the total amount of 
study drug administered relative to the total amount of study drug expected to be administered 
during a subject’s actual on-treatment period based on the study drug regimen.
The level of on-treatment adherence will be expressed as a percentage using the following 
formula:
Study drug expected to be administered for filgotinib 200 mg/PTM (tablets) = 1× total duration 
of exposure to study drug (days).
Descriptive statistics for the level of on-treatment adherence with the number and percentage of 
subjects belonging to adherence categories (eg, < 80%, ≥ 80 to < 90%, ≥ 90%) will be provided 
by treatment group for the Safety Analysis Set. 
Total Amount of Study Drug Administered
On-Treatment Adherence (%) = 
 x 100
Study Drug Expected to be Administered on Treatment





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No formal statistical testing is planned.
A by-subject listing of study drug administration and drug accountability will be provided 
separately by subject ID number (in ascending order) and visit (in chronological order).
4.3.
Protocol Deviations 
Subjects who did not meet the eligibility criteria for study entry, but randomized in the study will 
be summarized. The summary will present the number and percentage of subjects who did not 
meet at least 1 eligibility criterion and the number of subjects who did not meet specific criteria 
by treatment group based on the All Randomized Analysis Set. A by-subject listing will be 
provided for those subjects who did not meet at least 1 eligibility (inclusion or exclusion) 
criterion. The listing will present the eligibility criterion (or criteria if more than 1 deviation) that 
subjects did not meet and related comments, if collected.
Protocol deviations occurring after subjects entered the study are documented during routine 
monitoring. The number and percentage of subjects with important protocol deviations (IPDs) by 
deviation category (as specified in the IPD plan) will be summarized by treatment group for the 
All Randomized Analysis Set. A by-subject listing will be provided for those subjects with 
important protocol deviation.
4.4.
Assessment of COVID-19 Impact 
This study was ongoing during the novel coronavirus (COVID-19) pandemic which has an 
impact on the study conduct. Some participants were unable to attend onsite visits due to shelter 
in place guidelines, site closures, or other reasons. This section describes how special situations 
due to COVID-19 will be handled in the analysis.
4.4.1.
Study Drug or Study Discontinuation Due to COVID-19
A by-subject listing of reasons for premature study drug or study discontinuation due to 
COVID-19 will be provided if applicable. Similarly, a by-subject listing of reasons for 
prednisone discontinuation due to COVID-19 will be provided.
4.4.2.
Protocol Deviations Due to COVID-19
A by-subject listing will be provided for subjects with IPDs related to COVID-19 if applicable. 
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4.4.3.
Missed and Virtual Visits due to COVID-19
A by-subject listing of subjects with missed or virtual visits due to COVID-19 will be provided 
by subject ID number in ascending order.
Information regarding missed or virtual visits due to COVID-19 will be collected as free text in 
the CRF comment fields. The determination of missed or virtual visits due to COVID-19 will be 
performed using Natural Language Processing (NLP) to search the CRF comment fields.  A 
detailed explanation of the algorithm is given in Appendix 3.
4.4.4.
Adverse Events Due to COVID-19
Adverse events (AEs) of COVID-19 will be included in analyses of AEs if applicable, which will 
be determined through COVID-19 SMQ broad search. A by-subject listing of AEs of COVID-19 
will be provided if applicable.
4.4.5.
Overall Assessment of COVID-19 Pandemic Impact
For subjects affected by COVID-19 infection and/or pandemic while participating in the study, a 
listing of the following individual COVID-19 related outcome categories will be provided:

Death due to COVID-19

Adverse event of COVID-19, as determined by COVID-19 SMQ broad search

Specific adverse event directly associated with the pathogen causing COVID-19, as 
determined by MST

Hospitalization (using data from AE eCRF) due to adverse event of COVID-19 as defined 
above

Tested positive for COVID-19

Study drug discontinuation due to COVID-19

Study discontinuation due to COVID-19

Missed visits due to COVID-19  

Missed key assessments due to COVID-19 (key assessments are the assessments contributing 
to primary and secondary endpoints)
In addition, composite broad COVID-19 impact indicator will be derived based on the following 
individual categories defined above: death, adverse event, hospitalization, tested positive, study 
drug discontinuation, study discontinuation, missed visits, and missed key assessments. 


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Composite specific COVID-19 impact indicator will be derived based on death, specific adverse 
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5.
BASELINE CHARACTERISTICS
5.1.
Demographics and Baseline Characteristics
Subject demographic variables (ie, age, sex, race, and ethnicity) and other baseline 
characteristics (ie, body weight [in kg], height [in cm], body mass index [BMI; in kg/m2], 
smoking status) will be summarized by treatment group and overall using descriptive statistics 
for continuous variables, and using number and percentage of subjects for categorical variables. 
The summary of demographic and baseline characteristics data will be provided for the Safety 
Analysis Set.

Age (on the first dose date of any study drug)

Age group (< 65 years, ≥ 65 years)

Age group (< 30, ≥ 30 to < 50, ≥ 50 years) 

Sex at birth (male, female)

Race

Ethnicity (Hispanic or Latino, not Hispanic or Latino)

Weight (kg)

Height (cm)

Body mass index (BMI; in kg/m2)

Smoking status (non-smoker, former smoker, current smoker)   

Drinking status (non-drinker, former drinker, current drinker)
A by-subject demographic listing, including the informed consent date, will be provided by 
subject ID number in ascending order.
5.2.
Other Baseline Disesase Characteristics
Baseline disease characteristics include: 

Uveitis attributed to sarcoidosis (yes/no)

Baseline immunosuppressant usage (yes/no)

Prior use of anti-TNF therapy (yes/no)


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
Prior immunosuppressants (excluding corticosteriod) use (yes/no) during screening period: n 
(%)
Azathioprine
Methotrexate (MTX)
Adalimumab
Infliximab
Ciclosporin
Mycophenolate Mofetil

Prior Corticosteriod use (yes/no) during screening period: n (%)
Oral 
Ophthalmic 
Intraocular 
Other 

Concurrent immunosuppressants use (excluding corticosteriod) on the first dose date 
(yes/no): n (%)
Azathioprine
Methotrexate (MTX)
Adalimumab

Concurrent corticosteriod use on the first dose date (yes/no): n (%)
Oral 
Ophthalmic
Intraocular
Other 
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
Duration of current uveitis flare (month) 
Calculated as earlier start date (from two eyes) of the current uveitis flare to the first dose 
date, where the current uveitis flare is the study qualifying uveitis flare identified at the 
screening visit

Eye affected (left, right, both) for current uveitis flare 

Type of Uveitis (pan-uveitis, posterior uveitis,  intermediate uveitis, anterior + intermediate, 
posterior + intermediate) for current uveitis flare 

Etiology for current uveitis flare

History of infectious uveitis (yes, no)

Duration of uveitis (months) from the first uveitis flare 
Calculated as earlier start date (from two eyes) of the first uveitis flare to the first dose 
date

Time since last uveitis flare (months) at Baseline
Calculated as from later end date (from two eyes) of the last uveitis flare to earlier start 
date (from two eyes) of current uveitis flare

Number of uveitis flares in the past 12 months (1, 2, ≥ 3)

Corticosteroid use within 14 days prior to first dose
Oral corticosteroid use , n (%)

Maximum oral corticosteroid dose use within 14 days prior to first dose (mg) for subjecs who 
use oral corticosteroid, expressed as prednisone-equivalent dose, mean (SD)
The following baseline ophthalmologic variables will be summarized separately for left and 
right eye:

Optical coherence tomography (OCT) evidence of macular edema (yes, no) (based on central 
reader assessment at baseline)

Central retinal thickness (microns)

Intraocular pressure (mmHg)

Active lesions (yes, no) via Dilated Indirect Ophthalmoscopy (DIO) and lesion location
Chorioretinal: n (%)


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Retinal vascular: n (%)
Both chorioretinal and retinal vascular: n (%)
Other: n (%)

Anterior chamber cell grade (SUN criteria) (continuous)

Anterior chamber cell grade (SUN criteria) (categorical) 

AREDS lens opacity grading 
Nuclear opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
Cortical opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)
Posterior subcapsular opacity (grade < 1.0, 1.0, 1.5, 2.0, 2.5, 3.0, > 3.0)

Vitreous haze grades (NEI/SUN criteria) (continuous)

Vitreous haze grades (NEI/SUN criteria) (categorical) 

Best Corrected Visual Acuity (BCVA)

LogMAR BCVA, calculated as follows:
if ≥ 20 letters were read at 4 m OR if < 20 letters were read at 4 m but the test was not 
done at 1 m,
logMAR = 1.7 – 0.02 * (number of letters at 4 m + 30),
if < 20 letters were read at 4 m and the test was also done at 1 m,
logMAR = 1.7 – 0.02 * (number of letters read at 4 m + number of letters read at 
1 m)
if 0 letters were read at 1 m, the following logMAR values will be calculated according to 
Holladay:
in case of finger counting: logMAR = (–1) * log10 (distance in meters/60)
in case of hand movements: logMAR = 3.0
These baseline ocular characteristics will be summarized by treatment group and overall using 
descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and maximum) for continuous 
variables and using number and percentage of subjects for categorical variables. The summary of 


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baseline characteristics will be provided for the Safety Analysis Set. No formal statistical testing 
is planned.
A by-subject listing of other baseline disease characteristics will be provided by subject ID 
number in ascending order.
5.3.
Medical History
Medical history will be collected at screening for disease-specific and general conditions 
(ie, conditions not specific to the disease being studied).
General medical history collected at Screening will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA) v24.0. Medical history will be summarized by system organ 
class (SOC), preferred term (PT), treatment group, and overall. Subjects who report 2 or more 
medical history items that are coded to the same SOC and/or PT will be counted only once by the 
unique coded term in the summary. 
A by-subject listing of general medical history will be provided by subject ID number (in 
ascending order) and medical history of abnormalities (in chronological order). A by-subject 
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6.
EFFICACY ANALYSES
6.1.
General Consideration
The primary analysis set for efficacy analyses will be the Evaluable Analysis Set, defined in 
section 3.1.3.
Due to study early terminiation, the number of enrolled subjects is much smaller than planned, 
all the hypothesis testings performed and p-values reported will be nominal, and, unless specified 
otherwise, all the confidence intervals will be calculated based on the nominal level of 95%. The 
results need to be interpreted with caution.
Missing Data Consideration
Unless specified otherwise, below are the descriptions for the imputation methods that will be 
used throughout the efficacy analyses:

Observed case (OC): Missing values remain missing. For the categorical composite 
endpoints, in the case that some components are missing, the composite endpoint assessment 
will be derived based on the non-missing components. If non-missing components are not 
sufficient to determine final composite endpoint, then the composite endpoint will be set as 
missing. For example, the treatment failure status is a binary composite score derived based 
on four criteria. If one of the criteria (e.g., new lesion relative to baseline) is missing, the 
treatment failure status will be derived based on other three non-missing criteria (VH grade, 
ACC grade and BCVA score). However, if none of the three non-missing criteria meets the 
treatment failure definition, the treatment failure status will be set as missing.

Non-responder imputation (NRI): For all binary response measurements, all subjects with 
missing values will be analyzed as having the clinical event (i.e., treatment failure). 
6.2.
Primary Efficacy Endpoint
The primary efficacy endpoint is the proportion of subjects failing treatment by Week 24.
6.2.1.
Definition of the Primary Efficacy Endpoint
Subjects will be evaluated for treatment failure criteria as defined in Table 1-1. 
6.2.2.
Primary Analysis of the Primary Efficacy Endpoint
The primary hypothesis will consist of a superiority test of filgotinib compared to placebo based 
on proportion of subjects failing treatment by Week 24. The analysis will use 
Cochran-Mantel-Haenszel (CMH) approach adjusting for the stratification factors. The p-value 
from the CMH test for testing the superiority of filgotinib as compared to placebo will be 
provided. Subjects with missing values on treatment failure status will be analyzed as treatment 
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The non-stratified point estimate for treatment differences in proportions of subjects failing 
treatment by Week 24 between filgotinib and placebo along with its 95% confidence interval 
(CI) will be provided based on the normal approximation with a continuity correction. In 
addition, the numbers and percentages of subjects failing treatment in each treatment group with 
the corresponding 2-sided 95% CIs for the percentage based on a normal approximation method 
with a continuity correction will be presented. Appendix 4 provides sample SAS models 
statements for constructing the confidence interval for the proportion. 
A logistic regression analysis will also be performed to assess the odds ratio between treatment 
groups adjusting for stratification factors. The point estimate of odds ratio and the corresponding 
95% CI, as well as the  p-value, will be presented.
6.2.3.
Sensitivity Analysis of the Primary Endpoint
The following sensitivity analyses of the primary efficacy endpoint will be performed.

The analysis specified in section 6.2.2 will be performed using Full Analysis Set. The 
missing data will be imputed using non-responder imputation.

The analysis will also be performed using the observed data only. The missing data will be 
not be imputed, i.e. the subjects who discontinue from the study will be excluded from the 
analysis.
6.2.4.
Subgroup Analysis of the Primary Endpoint
Subgroup analyses comparing filgotinib group to the placebo group will be performed for the 
primary endpoint, for the subgroups specified in Section 3.4.
The proportion of subjects failing treatment by Week 24 between filgotinib and placebo will be 
compared using the stratified CMH test based on the NRI method with corresponding p-value 
provided. The non-stratified point estimate and 95% CIs for the differences in proportions 
between filgotinib and placebo, and 95% CIs for proportion of responders in each treatment 
group based on a normal approximation method with a continuity correction will be presented. 
When the grouping variable is identical to one of the stratification factors, this stratification 
factor will not be adjusted in the modeling. In the case there were not sufficient data to meet the 
assumptions of the analysis, i.e. < 5 subjects within a stratification stratum, a Fisher exact test 
will be conducted instead.
6.3.
Secondary Efficacy Endpoints
The secondary efficacy endpoints include:

Time to treatment failure on or after Week 6


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
Change in VH grade in each eye (NEI/SUN criteria), from best state achieved prior to 
Week 6 to Week 52/EOT visit or ET visit

Change in AC cell grade in each eye, from best sate achieved prior to Week 6 to 
Week 52/EOT visit or ET visit

Change in logMAR BCVA in each eye, from best state achieved prior to Week 6 to 
Week 52/EOT visit or ET visit

Log change in central retinal thickness in each eye, from best state achieved prior to Week 6 
to Week 52/EOT visit or ET visit

Time to development of macular edema in at least one eye as determined by OCT on or after 
Week 6 
6.3.1.
Definition of Secondary Efficacy Endpoints
6.3.1.1.
Anterior Chamber Cell Grade
The number of Anterior Chamber (AC) cells observed within a 1 mm × 1 mm slit beam will be 
recorded for each eye. The reported number will be used to determine the grade according to the 
Standardization of Uveitis Nomenclature (SUN) criteria (Table 6-1).
Table 6-1.
Anterior Chamber Cells
Grade 
Cells in Field
0
< 1
0.5 +
1 – 5
1 +
6 – 15
2 +
16 – 25
3 +
26 – 50
4 +
> 50
Anterior chamber cell grades range from 0 to 4+, with higher scores indicating more cells visible 
in the anterior chamber and greater severity of uveitis.
6.3.1.2.
Vitreous Haze Grading
Grading of vitreous haze will be based on the publication from the National Eye Institute (NEI) 
which has also been adapted by the SUN working group (Table 6-2). 


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Table 6-2.
Vitreous Haze 
Grade 
Description
0
No evident vitreal haze
0.5 +
Slight blurring of the optic disc margin because of the haze; normal striations and 
reflex of the nerve fiber layer cannot be visualized
1 +
Permits a better definition of both the optic nerve head and the retinal vessels 
(compared to higher grades)
2 +
Permits better visualization of the retinal vessels (compared to higher grades)
3 +
Permits the observer to see the optic nerve head, but the borders are quite blurry
4 +
Optic nerve head is obscured
Vitreous haze grades range from 0 to 4+, with higher scores indicating greater severity of uveitis.
6.3.1.3.
Best Corrected Visual Acuity (BCVA)
Best Corrected Visual Acuity (BCVA) is the best possible vision that an eye can achieve with the 
use of glasses or contact lenses. A refraction test is performed to measure the appropriate lens 
strength to focus light on the retina. Using the appropriate corrective lenses based on that visit’s 
refraction, subject’s BCVA is measured using an ETDRS chart. In the ETDRS system, 15 letters 
is equal to a change in 3 lines of visual acuity, for example, from 20/40 to 20/20 or vice versa, a 
halving or doubling of the visual angle; a change of 7.5 letters corresponds to a 25% decrease or 
50% increase in the visual angle. Clinically, it is the single BCVA for each eye that represents 
the maximal visual potential. If the subject is unable to read letters on a testing chart, visual 
acuity is described as ranging from ability to count fingers, recognize hand movements, or light 
perception.
The smaller BVCA score indicates greater severity of uveitis.
6.3.1.4.
Central retinal thickness
Central retinal thickness is measured by optical coherence tomography (OCT). Full retinal 
thickness is defined as the distance between the inner limiting membrane and the apical 
boundary of the retinal pigment epithelium. Central retinal thickness is defined as the thickness 
of the retina in the center of the foveal pit (1 mm subfield).
The larger central retinal thinkness value indicates greater severity of uveitis.
6.3.1.5.
Macular edema
Macular edema is defined as central retinal thickness ≥ 300 microns if using Cirrus machine, or 
≥ 315 microns if using Spectralis machine.


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6.3.2.
Analysis Methods for Secondary Efficacy Endpoints
The time to treatment failure and the time to OCT evidence of macular edema will be based on 
the first eye to meet the criteria for treatment failure or macular edema. 
The change in anterior chamber cell grade in each eye from best state achieved prior to Week 6 
to Week 52/EOT or ET Visit, change in vitreous haze grade in each eye from best state achieved 
prior to Week 6 to Week 52/EOT or ET, change in best corrected visual acuity (logarithm of the 
minimum angle of resolution) in each eye from best state achieved prior to Week 6 to 
Week 52/EOT or ET, and log change in central retinal thickness in each eye from best state 
achieved prior to Week 6 to Week 52/EOT or ET Visit will be analyzed using data from each eye 
individually. 
The best state for the VH grade and AC cell grade is defined as the minimum grade prior to 
Week 6, and the best state for BCVA is defined as the maximum score prior to Week 6. The best 
state for central retinal thickness is the minimum value prior to Week 6. 
The time to treatment failure on or after Week 6 will be compared between the filgotinib group 
and the placebo group with a stratified log-rank test. A proportional-hazards model with the 
treatment group as a factor and stratification factors as covariates will be fitted to estimate the 
hazard ratio with its 95% confidence interval. Appendix 5 provides sample SAS models 
statements for constructing the stratified log-rank test and the proportional-hazards model. In 
additional, time to treatment failure on or after Week 6 due to each individual component of 
treatment failure criteria will be analyzed similarly.
Treatment failures on or after Week 6 will be counted as events; subjects who complete the study 
and don’t have events or permanently discontinue from study due to reasons other than treatment 
failure at any time during the study will be considered as censored observations. Time (in weeks) 
to the clinical event (eg, treatment failure) will be calculated as: (earliest date of clinical 
event - first dose date + 1) / 7. Those who are not observed to have the specified events by the 
end of study completion or by the time of discontinuation from study will be censored at the date 
of their last available assessment. 
The time to macular edema on or after Week 6 will be analyzed in the same way as for time to 
treatment failure analysis. OCT evidence of macular edema on or after Week 6 will be counted 
as event; subjects who complete the study and don’t have macular edema or permanently 
discontinue from study at any time during the study will be considered as censored observations. 
Similar analyses will also be performed for subjects with and without pre-existing macular 
edema at baseline, respectively.
For time to event endpoints, the Kaplan - Meier (KM) estimates of clinical event probability and 
95% CIs for each treatment group will be presented at Week 6, 12, 24, 36, 48, and 52. The 95% 
CI will be calculated based on a log-log transformation of the survival function. Median, Q1 and 
Q3 of the time to first clinical event will also be provided for each treatment group with the 
corresponding 95% CIs based on the log-log transformation of the survival function. The KM 
curves will be plotted for treatment failure or macular edema by treatment groups, respectively. 


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For continuous endpoints of change in Vitreous Haze grade, change in AC cell grade, change in 
BCVA (logarithm of the minimum angle of resolution), and log change in central retinal 
thickness will be compared between treatment groups using the repeated measures Analysis of 
Covariance (ANCOVA) to control for clustered observations (i.e., observations from each of the 
subject's eyes), with treatment, subject’s eyes, interaction of treatment and subject’s eys, 
stratification factors and best state values as covariates. For log change in central retinal 
thickness, the analysis will additionally be adjusted for type of OCT machines. Least squares 
mean estimate and 95% CI of treatment difference between filgotinib and placebo in change 
from baseline at Week 52/EOT or ET visit and corresponding p-value from the ANCOVA model 
will be provided. Least squares mean estimate and 95% CI will also be presented for each 
treatment group.
For all the continuous endpoints, absolute value and change from best state will be summarized 
using descriptive statistics (sample size, mean, SD, median, Q1, Q3, minimum, and maximum) 
by treatment and by visit.  For central retinal thickness, the descriptive summary will also be 
provided by visit for subjects with and without pre-existing macular edema at baseline, 
respectively. In addition, plots of mean ± SD for change from the best state by visit will be 
presented. For log change in central retinal thickness, plots of mean ± SD for change from 
Baseline will also be provided.
6.3.3.
Sensitivity Analysis for Key Secondary Efficacy Endpoints
The following sensitivity analyses of the key secondary efficacy endpoints will be performed.

For time to treatment failure on or after Week 6, subjects who permanently disconinute from 
study at any time during the study will be considered as having events at the time of 
discontinuation from study. 

For time to macular edema on or after Week 6, subjects who permanently disconinute from 
study at any time during the study will be considered as having events at the time of 
discontinuation from study. 
6.3.4.
Subgroup Analysis of the Key Secondary Endpoints
Subgroup analyses comparing filgotinib group to the placebo group will be performed
for the key secondary endpoints, for the subgroups specified in Section 3.4.
For continus key secondary endpoint, the repeated measures ANCOVA with treatment, subject’s 
eyes, interaction of treatment and subject’s eyes, stratification factors and best state value as 
covariates will be performed. 
For time to event endpoints, the stratified log-rank test will be used to compare the filgotinib 
group and the placebo group. The Kaplan-Meier estimates of clinical event probability and 95% 
CIs at Week 6, 12, 24, 36, 48, and 52 for each treatment group will also be presented. Median, 
Q1 and Q3 of the time to the first clinical event will also be provided for each treatment group. 


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The point estimates and 95% Cls based on propo1i ional hazard model will also be provided in 
the subgroup analysis. 
When the grouping variable is identical to one of the stratification factors, this stratification 
factor will not be adjusted in the modeling. 
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Changes From Protocol-Specified Efficacy Analyses 
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On 15 December 2020, Gilead decided to halt the study at an emolhnent of 74 subjects despite 
the study not achieving complete emollment of planned 248 subjects. The discontinuation of 
global development for filgoginib was a business decision and not because of any safety 
concerns with filgotinib or the study procedures. 
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7.
SAFETY ANALYSES
7.1.
Adverse Events and Deaths
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using the current version of 
MedDRA. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), 
preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset.
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to toxicity 
criteria specified in the protocol. The severity grade of events for which the investigator did not 
record severity will be categorized as “missing” for tabular summaries and data listings. The 
missing category will be listed last in summary presentation.
7.1.3.
Relationship of Adverse Events to Study Drug
Related AEs are those for which the investigator selected “Related” on the AE CRF to the 
question of “Related to Study Treatment.” Relatedness will always default to the investigator’s 
choice, not that of the Medical Monitor. Events for which the investigator did not record 
relationship to study drug will be considered related to study drug for summary purposes. 
However, by-subject data listings will show the relationship as missing.
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and captured as SAEs if AEs met the definitions 
of SAEs that were specified in the study protocol. SAEs captured and stored in the clinical 
database will be reconciled with the SAE database from the Gilead Global Patient Safety 
Department before data finalization.
7.1.5.
Treatment-Emergent Adverse Events 
7.1.5.1.
Definition of Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as one or both of the following:

Any AEs with an onset date on or after the study drug start date and no later than 30 days 
after permanent discontinuation of study drug

Any AEs leading to premature discontinuation of study drug


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7.1.5.2.
Incomplete Dates
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met:

The AE onset is the same as or after the month and year (or year) of the first dosing date of 
study drug, and

The AE onset date is the same as or before the month and year (or year) of the date 
corresponding to 30 days after the date of the last dose of study drug 
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent.
7.1.6.
Summaries of Adverse Events and Deaths
Treatment-emergent AEs will be summarized based on the Safety Analysis Set.
7.1.6.1.
Summaries of AE incidence in Combined Severity Grade Subsets 
A brief, high-level summary of the number and percentage of subjects who experienced at least 
1 TEAE in the categories described below will be provided by treatment group. All deaths 
observed in the study will also be included in this summary.
The number and percentage of subjects who experienced at least 1 TEAE will be provided and 
summarized by SOC, HLT (if applicable), PT, and treatment group:

TEAEs
For the AE categories described below, summaries will be provided by SOC, PT, and treatment 
group:

TEAEs of Grade 3 or higher

TEAEs of Grade 2 or higher

TE treatment-related AEs

TE treatment-related AEs of Grade 3 or higher

TE treatment-related AEs of Grade 2 or higher

TE SAEs

TE treatment-related SAEs 


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
TEAEs leading to premature discontinuation of any study drug

TEAEs leading to premature discontinuation of study

TEAEs leading to temporary interruption of study drug

TEAEs leading to death (ie, outcome of death)

Death
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC (and HLT within each SOC if applicable), 
and then by PT in descending order of total frequency within each SOC. For summaries by 
severity grade, the most severe grade will be used for those AEs that occurred more than once in 
an individual subject during the study. 
In addition to the above summary tables, all above AE categories will be summarized by PT 
only, in descending order of total frequency.
In addition, data listings will be provided for the following:

All AEs, indicating whether the event is treatment emergent

All AEs of Grade 3 or higher

All AEs of Grade 2 or higher

All SAEs

All AEs leading to premature discontinuation of any study drug

All AEs leading to premature discontinuation of study

All AEs leading to temporary interruption of study drug

All deaths

All AEs leading to death (ie, outcome of death)
7.1.6.2.
Summaries of AE incidence by Severity
A brief, high-level summary of the number of percentage of subjects who experienced at least 
1 TEAE in the categories described below will be provided by treatment group. All deaths 
observed in the study will also be included in this summary.
For the AE categories described below, summaries will be provided by SOC, PT, and treatment 
group:

TEAEs by maximum severity 

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Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC (and HLT within each SOC if applicable), 
and then by PT in descending order of total frequency within each SOC. For summaries by 
severity grade, the most severe grade will be used for those AEs that occurred more than once in 
an individual subject during the study. 
7.1.7.
Adverse Events of Interest
Events of interest will be identified by the use of either SMQs or MedDRA search terms (MSTs). 
However, should additional cases not detected by the predefined search term listings be 
identified during the clinical review process, these cases will also be reported by respective 
category.
7.1.7.1.
Adjudication Committee for Major Adverse Cardiovascular Events (MACE) and 
Thromboembolic Events
An independent adjudication committee governed by an adjudication charter will be set up to 
perform periorically adjudication of potential MACE as well as thromboembolic events reported 
during the study. 
7.1.7.1.1.
Major Adverse Cardiovascular Events (MACE)
MACE will be comprised of cardiovascular (CV) death, non-fatal myocardial infarction (MI) 
and non-fatal stroke. To identify the MACE, the following potential cases will be adjudicated:

All deaths

Cardiovascular events (meeting serious criteria)

Myocardial infarction (Narrow scope SMQ)

Hospitalization for unstable angina

Transient ischemic attack

Stroke

Hospitalization for cardiac failure

Percutaneous coronary intervention
7.1.7.1.2.
Thromboembolic Events
Thromboembolism events will be comprised of arterial systemic thromboembolism events 
(ASTE) and venous thromboembolism events (VTE) associated with deep vein thrombosis 
(DVT) and/or pulmonary embolism (PE). To identify the thromboembolism events, the potential 
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The adjudication committee will review those potential MACE and thromboembolic events and 
related clinical data to determine whether a MACE or thromboembolism event has developed.  
The number and percentage of subjects with positively adjudicated MACE or thromboembolic 
events will be summarized by treatment group using PT.
By-subject listings for all randomized subjects who have potential MACE or thromboembolic 
events will be provided respectively.
7.1.7.2.
 Other Adverse Events of Interest
In addition to general safety parameters, MACE and thromboembolic Events, safety information 
on other adverse events of interest (AEIs) will also be analyzed. AEIs will be identified by either 
laboratory results, standardized MedDRA queries (SMQs), or sponsor defined MSTs, or a 
combination of these methods as indicated below. 

All infections (defined as all PTs in the Infections and Infestations SOC)

Serious infections (defined as all PTs in the Infections and Infestations SOC that are SAEs)

Infections of special interest identified by MSTs
a) Herpes zoster
b) Active tuberculosis
c) Opportunistic infections (OIs)
d) Hepatitis B or C infections

Malignancies (including lymphoma; excluding non-melanoma skin cancers) identified by 
MSTs

Nonmelanoma skin cancer 

Gastrointestinal (GI) perforation 

Uveitis-related AEs
The number and percentage of patients with aforementioned events of interest will be provided 
by the PT term for each AE of special interests.
A by-subject listing for all patients having AE of interests at any time will be provided for each 
AE of interest.


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7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to the last dose of any study drug plus 
30 days for subjects who have permanently discontinued study drug, or all available data at the 
time of the database snapshot for subjects who were ongoing at the time of an interim analysis. 
The analysis will be based on values reported in conventional units. When values are below the 
LOQ, they will be listed as such, and the closest imputed value will be used for the purpose of 
calculating summary statistics as specified in Section 3.7. 
A by-subject listing for laboratory test results will be provided by subject ID number and visit in 
chronological order for hematology, serum chemistry, and urinalysis separately. Values falling 
outside of the relevant reference range and/or having a severity grade of 1 or higher on the 
CTCAE severity grade will be flagged in the data listings, as appropriate.
No formal statistical testing is planned.
7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics will be provided by treatment group for each laboratory test specified in the 
study protocol as follows:

Baseline values 

Values at each postbaseline visit 

Change from baseline at each postbaseline visit
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of any study drug. Change from baseline to a postbaseline visit will be 
defined as the visit value minus the baseline value. The mean, median, Q1, Q3, minimum, and 
maximum values will be displayed to the reported number of digits; SD values will be displayed 
to the reported number of digits plus 1.
Median (Q1, Q3) of the observed values for the laboratory tests specified above will be plotted 
using a line plot by treatment group and visit.
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3.
7.2.2.
Graded Laboratory Value
The CTCAE Version 4.03 (with one modification specified in protocol) will be used to assign 
toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 includes all values that do not 
meet the criteria for an abnormality of at least Grade 1. For laboratory tests with criteria for both 
increased and decreased levels, analyses for each direction (ie, increased, decreased) will be 
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7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of any study drug plus 30 days for subjects who permanently discontinued study drug, or 
the last available date in the database snapshot for subjects who were still on treatment at the 
time of an interim analysis. 
If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed 
within the time frame specified above will be considered treatment emergent.
7.2.2.2.
Treatment-Emergent Marked Laboratory Abnormalities
Treatment-emergent marked laboratory abnormalities are defined as values that increase from 
baseline by at least 3 toxicity grades at any postbaseline time point, up to and including the date 
of the last dose of any study drug plus 30 days for subjects who permanently discontinued study 
drug or the last available date in the database snapshot for subjects who were still on treatment at 
the time of an interim analysis.
If the relevant baseline laboratory value is missing, any Grade 3 or higher values observed within 
the timeframe specified above will be considered treatment-emergent marked abnormalities.
7.2.2.3.
Summaries of Laboratory Abnormalities
Laboratory data that are categorical will be summarized using the number and percentage of 
subjects in the study with the given response at baseline and each scheduled postbaseline visit.
The following summaries (number and percentage of subjects) for treatment-emergent laboratory 
abnormalities will be provided by lab test and treatment group; subjects will be categorized 
according to the most severe postbaseline abnormality grade for a given lab test:

Graded laboratory abnormalities

Grade 3 or higher laboratory abnormalities

Marked laboratory abnormalities
For all summaries of laboratory abnormalities, the denominator is the number of subjects with 
nonmissing postbaseline values up to 30 days after last dosing date.
A by-subject listing of treatment-emergent Grade 3 or higher laboratory abnormalities and 
marked laboratory abnormalities will be provided separately by subject ID number and visit in 
chronological order. These listings will include all test results that were collected throughout the 
study for the lab test of interest, with all applicable severity grades or abnormal flags displayed.


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7.2.3.
Liver-related Laboratory Evaluations
Liver-related abnormalities after initial study drug dosing will be examined and summarized 
using the number and percentage of subjects who were reported to have the following laboratory 
test values for postbaseline measurements:

Aspartate aminotransferase (AST): (a) > 3 times of the upper limit of reference range  
(ULN); (b) > 5 x ULN; (c) > 10 x ULN; (d) > 20 x ULN

Alanine aminotransferase (ALT): (a) > 3 x ULN; (b) > 5 x ULN; (c) > 10 x ULN; 
(d) > 20 x ULN

AST or ALT: (a) > 3 x ULN; (b) > 5 x ULN; (c) > 10 x ULN; (d) > 20 x ULN

Total bilirubin: (a) > 1 x ULN; (b) > 2 x ULN

Alkaline phosphatase (ALP) > 1.5 x ULN

AST or ALT > 3 x ULN and total bilirubin: (a) > 1.5 x ULN; (b) > 2 x ULN

AST or ALT > 3 x ULN, total bilirubin > 2 x ULN and ALP < 2 x ULN
The summary will include data from all postbaseline visits up to 30 days after the last dose of 
any study drug. For individual laboratory tests, subjects will be counted once based on the most 
severe postbaseline values. For both the composite endpoint of AST or ALT and total bilirubin, 
subjects will be counted once when the criteria are met at the same postbaseline visit date. The 
denominator is the number of subjects in the Safety Analysis Set who have nonmissing 
postbaseline values of all relevant tests at the same postbaseline visit date. A listing of subjects 
who met at least 1 of the above criteria will be provided.
7.3.
Body Weight and Vital Signs
Descriptive statistics will be provided by treatment group for body weight, BMI and vital signs 
(systolic and diastolic blood pressures [mmHg], pulse [beats/min] ) as follows:

Baseline value

Values at each postbaseline visit 

Change from baseline at each postbaseline visit 
A baseline value will be defined as the last available value collected on or prior to the date/time 
of first dose of any study drug. Change from baseline to a postbaseline visit will be defined as 
the postbaseline value minus the baseline value. Body weight and vital signs measured at 
unscheduled visits will be included for the baseline value selection. 


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In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3. No formal statistical testing is planned.
A by-subject listing of vital signs (systolic and diastolic blood pressure [mmHg], pulse 
[beats/min], and body temperature [oC]) will be provided by subject ID number and visit in 
chronological order. In the same manner, a by-subject listing of body weight, height, and BMI 
will be provided separately
7.4.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the World Health 
Organization (WHO) Drug dictionary version BMAR21.
All the analyses in this section will be performed for general prior /concomitant medications and 
Uveitis-specific prior /concomitant medications separately, unless otherwise specified.
7.4.1.
Prior Medications
Prior medications are defined as any medication taken before a subject took the first study drug.
Prior medications will be summarized by preferred name using the number and percentage of 
subjects for each treatment group and overall. A subject reporting the same medication more 
than once will be counted only once when calculating the number and percentage of subjects 
who received that medication. The summary will be ordered alphabetically by preferred name in 
order of descending overall frequency. For drugs with the same frequency, sorting will be done 
alphabetically.
For the purposes of analysis, any medication with a start date prior to the first dosing date of any 
study drug will be included in the prior medication summary regardless of when the stop date is. 
If a partial start date is entered the medication will be considered prior unless the month and year 
(if day is missing) or year (if day and month are missing) of the start date are after the 
first dosing date. Medications with a completely missing start date will be included in the prior 
medication summary, unless otherwise specified. 
Summaries will be based on the Safety Analysis Set. No formal statistical testing is planned.
7.4.2.
Concomitant Medications
Concomitant medications are defined as medications taken while a subject took study drug. Use 
of concomitant medications will be summarized by preferred name using the number and 
percentage of subjects for each treatment group. A subject reporting the same medication more 
than once will be counted only once when calculating the number and percentage of subjects 
who received that medication. The summary will be ordered alphabetically by preferred name in 
descending overall frequency. For drugs with the same frequency, sorting will be done 
alphabetically.


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For the purposes of analysis, any medication with a start date prior to or on the first dosing date 
of any study drug and continued to take after the first dosing date, or started after the first dosing 
date but prior to or on the last dosing date of study drug will be considered concomitant 
medications. Medications started and stopped on the same day as the first dosing date or the last 
dosing date of any study drug will also be considered concomitant. Medications with a stop date 
prior to the date of first dosing date of any study drug or a start date after the last dosing date of 
any study drug will be excluded from the concomitant medication summary. If a partial stop date 
is entered, any medication with the month and year (if day is missing) or year (if day and month 
are missing) prior to the date of first study drug administration will be excluded from the 
concomitant medication summary. If a partial start date is entered, any medication with the 
month and year (if day is missing) or year (if day and month are missing) after the study drug 
stop date will be excluded from the concomitant medication summary. Medications with 
completely missing start and stop dates will be included in the concomitant medication summary, 
unless otherwise specified. 
Summaries will be based on the Safety Analysis Set. No formal statistical testing is planned.
All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order.
7.5.
Electrocardiogram Results
7.5.1.
Investigator Electrocardiogram Assessment
ECGs are only collected at the screening visit. A by-subject listing of ECG assessment results at 
screening will be provided.
7.6.
Other Safety Measures
A data listing will be provided for subjects who become pregnant during the study.
7.7.
Changes From Protocol-Specified Safety Analyses
There are no deviations from the protocol-specified safety analyses.


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8.
PHARMACOKINETIC ANALYSES
Concentrations of filgotinib and its metabolite GS-829845 in plasma will be determined using 
validated bioanalytical assays.
Individual subject concentration data for filgotinib and GS-829845 will be listed. Individual 
concentration data listings will include all subjects with concentration data. PK sampling details 
by subject, including procedures, differences in scheduled and actual draw times if applicable, 
and sample age will be provided in listings.
Due to study early termination, individual concentration data summaries will not be provided; 
No pharmacokinetic (PK) parameters will be derived and no analyses for PK parameters will be 
performed. 


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10.
REFERENCES
Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, et al. Adalimumab in 
Patients with Active Noninfectious Uveitis. N Engl J Med. 2016;375 (10):932-43.
Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD, et al. Development of the 
25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol 
2001;119 (7):1050-8.


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11.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.


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12.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision


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13.
APPENDICES
Appendix 1.
Corticosteroids Dose Conversion Chart
The following table will be used for converting non-prednisone medications to prednisone 
equivalent:
Example: Subject is taking 8 mg of Methylprednisolone orally daily. To get the equivalent dose 
of prednisone: 8 mg Methylprednisolone = (5*8)/4 = 10 mg prednisone. 
Corticosteroids Name
Equivalent Dose (mg) to 5 mg Prednisone
Dexamethasone
0.75 mg
Methylprednisolone
4 mg
Prednisolone
5 mg
Prednisone
5 mg


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Appendix 2.
Study Procedures Table
Screening
Day 1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 / End 
of 
Treatment
--or--
Early Term-
ination Visit
4 Week
Post-
Treatment 
Follow-Up 
Visitt
Visit Window
Within -
30 days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(+7 days)
Written Informed 
Consent
X
Review 
Inclusion/Exclusion 
X
Medical History 
X
Complete/ Symptom-
Driven Physical 
Examination a
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Vital Signs b
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
12-lead ECG
X
TB Test and Chest 
X-rayc,d
X
Hematologyd
Xv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemistryd
Xv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Lipid Profile (Fasting)e
X
X
X
ANA Testf
X
Syphilis Testd,g
X
Serology Testingh
Xv


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Screening
Day 1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 / End 
of 
Treatment
--or--
Early Term-
ination Visit
4 Week
Post-
Treatment 
Follow-Up 
Visitt
Visit Window
Within -
30 days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(+7 days)
HBV Viral 
Monitoringh
X
X
X
X
X
Urine drug test i 
Xv
Urinalysisd
Xv
X
X
X
X
X
Urine or Serum 
Pregnancy Testj
Xv
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum FSHk
Xv
PKm
X
X
X
X
X
X
X
Best Corrected Visual 
Acuity Testing 
(BCVA)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Slit Lamp Exam
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Tonometry 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CCICCI


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Screening
Day 1 / 
Baseline
Wk
1
Wk
4
Wk
6
Wk
8
Wk 
12
Wk 
16
Wk 
20
Wk 
24
Wk 
28
Wk 
32
Wk 
36
Wk 
40
Wk 
44
Wk 
48
Unscheduled 
Visit related 
to Uveitis 
Symptomsu
Wk 52 / End 
of 
Treatment
--or--
Early Term-
ination Visit
4 Week
Post-
Treatment 
Follow-Up 
Visitt
Visit Window
Within -
30 days
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(±3 
days)
(+7 days)
Dilated Indirect 
Ophthalmoscopy
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Fundus Color 
Photography (both 
eyes) 
X
X
X
Fluorescein 
Angiogram (both eyes)
X
X
X
Optical Coherence 
Tomography (OCT) 
Scan (both eyes)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Prior and Current 
Uveitis Medication
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
In Clinic Study Drug 
Dosingr
X
X
X
X
Study Drug 
Dispensationr
X
X
X
X
X
X
X
X
X
X
X
X
X
Prednisone 
Dispensations
X
X
X
Drug Accountability
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CCI
CCI
CCI
CCI
----------------------------------------------------------------------------
----------------------------------------------------------------------------
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Wk 52/ End 
of 
4 Week 
Unscheduled Treatment 
Post-
Vstrelated 
-or-
Treaonent 
Day l/ 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
Wk 
to u,,ems 
Ealiy Tetm Follow-Up 
Screening Baseline 
1 
4 
6 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
Symptoms• ination Vi9t 
Vst' 
Wrthin-
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
(±3 
Vi5it Window 
30 days 
da)'S) 
days) 
days) 
days) 
da)'S) 
days) 
days) 
da)'S) 
days) 
days) 
days) 
days) 
days) 
days) 
(+7 days) 
AdverseEveals 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CooMeds 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
a 
b 
C 
d 
e 
f 
g 
h 
k 
r 
m 
I 
I 
Complete PE will be pe1fo1med at Screening and Week 52 or ET/EOT. Symptom-driven PE will be performed at all other visits. 
Vital signs include resting blood pressure, pulse, and temperattu·e. 
Subjects must have the QuantiFERON® TB-Gold In-Tube test AND a chest radiograph (views as per local guidelines) taken at screening or within 3 months prior to screening 
(with the repo1t or fihns available for investigator review). Subjects with evidence of a negative QuantiFERON® TB-Gold In-Tube test result within 3 months will not require 
a re-test at Screening. QuantiFERON® TB-Gold can be processed locally. 
The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the central lab. For Chemistiy panel, Uric acid to be tested 
at screening only per protocol Appendix 6. Refer to list provided in Laboratory assessment table (protocol Appendix 6). 
Fasting lipid on Day 1 and Week 24. Week 52/EOT or ET visit lipid can be obtained fasting or non-fasting. 
Stt1dy personnel will collect a sample for antinuclear (ANA) and reflex double stl'anded-DNA antibody testing at the Day I/Baseline visit. A repeat ANA/Anti-ds-DNA 
would be wall'anted if a subject has clinical signs and symptoms suggestive oflupus. The Anti-ds-DNA antibody testing will be performed in case of positive ANA result. 
Subjects whom tmderwent syphilis screening (either a FTA test or a syphilis IgG test) for standard of care purposes within 3 months prior to Screening and evidence of a 
nonreactive FTA or syphilis IgG test result will not require a re-test at Screening. 
HBsAg and core Ab (if positive core Ab, then reflex Hep B DNA), Hepatitis C Ab, (if positive then, reflex HCV RNA), HIV 1/2 antigen/antibody combination test 
(4th generation). (protocol Appendix 6). The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the cent!'al lab. 
Subjects w'ith positive HBV core Ab, and negative HBV DNA are eligible per investigator judgment, but may require prophylactic treatment in accordance with HBV 
ti·eatment guidelines/local standard of care and require ongoing monitoring with blood tests for HBV DNA eve1y 3 months. 
Drug screen to be conducted at screening only per protocol Appendix 6. The required screening labs can be obtained either using the sites local lab or by submitt.ing 
appropriate samples to the centi·al lab. 
Females of childbea1'ing potential only. Senun pregnancy test at Screening and Urine pregnancy test to be conducted eve1y 4 weeks dtu'ing the dosing period through 35 days 
after their last dose of study drug. The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the centi·al lab. 
For female subjects <54 and amenoll'hea :2:12 months. The required screening labs can be obtained either using the sites local lab or by submitting appropriate samples to the 
centi·al lab. 
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r 
tu y ug w1 
e 1spense to su 1ects every wee s unt1 
ee 
or pnor to t 1e 
stu y v1s1t. 
Version 1.0 
s 
Prednisone will be dispensed to subjects at Day I/Baseline (Dose strengths 20 mg and 10 mg), Week 6 (Dose strengths 5 mg and 2.5 mg) and Week 8 (Dose strength I mg). 
4 Week Post Treatment Follow Up Visit to be completed at the end of the Randomized Double-Masked study. 
u 
If a subject presents at a site for an Unscheduled visit with symptoms related to a uveitis flare, subjects should be evaluated for treatment failure criteria. If treatment failure 
criteria are met, investigators should complete EOT procedtu·es. If a subject presents at a site for an Unscheduled visit not related to a uveitis flare, investigators should 
complete Unscheduled visit procedures at their discretion. 
v 
Tests obtained for standard of care ptuposes within 30 days of Day I/Baseline may be used to satisfy eligibility criteria. Refer to list provided in Laborato1y assessment table 
(protocol Appendix 6) 
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Appendix 3.
Data Collection of COVID-19 Data
This appendix describes the clinical trial site collection of COVID-19 data pertaining to 
missed/virtual visits and the data processing algorithm that will be used to determine which visits 
are missing and which visits are virtual.
Data collection
A COVID-19 supplement to the eCRF Completion Guidelines (CCG) was provided by Clinical 
Data Management to instruct clinical trial sites with data entry expectations pertaining to 
scenarios related to the COVID-19 pandemic.  If a visit was missed, sites were instructed to enter 
“Visit missed due to COVID-19” and if a in-person visit was conducted virtually, sites were 
instructed to enter “Virtual visit due to COVID-19”.  
Determination of Missed and Virtual Visits
Natural Language Processing (NLP) will be used to search the CRF comment fields to identify 
instances of “COVID-19”, “Virtual”, or synonyms (see Table 13-1).  The search terms will be 
maintained in a global lookup and can be modified to tune the NLP model.  Any comments with 
COVID-19 search terms, “Missed visit” or “Virtual visit” will be assigned as follows:
i)
IF COVID-19 terms are identified through NLP and the visit date is missing, then 
result is ‘Missed Visit’
ii) IF COVID-19 and Virtual terms are identified through NLP for a visit, then result is  
‘Virtual Visit’. When there are multiple records for the same subjects and the same 
visit, if one record could be categorized as “Virtual Visit”, all records associated with 
this subject and this visit will be categorized as “Virtual Visit”
iii) Otherwise result is missing
Table 13-1.
Examples Search Terms for “COVID-19” and “Virtual” Used to 
Identify Missed/Virtual Visits.
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Appendix 4.
Sample SAS Code for Analysis of Binary Endpoints
The following model statement will be used to construct the confidence interval for the binomial 
proportion difference described in Section 6.3.2:
proc freq data = test ;
by avisitn;
tables TRT01PN*aval_ / riskdiff (CORRECT); 
output out = f200vp_ci RISKDIFF;
where TRT01PN = 1 | TRT01PN = 3;
run;
where the confidence interval for the difference of two independent binomial proportions is 
constructed based on the normal approximation (ie, the Wald method) with a continuity 
correction, to adjust for the difference between the normal approximation and the binomial 
distribution, which is a discrete distribution:
(𝑝1 ― 𝑝2) ± ( 1
2
1
𝑛1 +
1
𝑛2 + 𝑧𝛼/2 ×
𝑝1(1 ― 𝑝1)
𝑛1
+ 𝑝2(1 ― 𝑝2)
𝑛2
)
The following model statement will be used to construct the confidence interval for the binomial 
proportion described in the Section 6.3.2:
proc freq data = test ;
by avisitn TRT01PN;
tables aval_ / BINOMIAL (CORRECT); 
run;
the confidence interval for the binomial proportions is constructed based on the normal 
approximation to the binomial distribution with continuity correction:
𝑝1 ± ( 1
2
1
𝑛1 + 𝑧
𝛼/2
×
𝑝1(1 ― 𝑝1)
𝑛1
)
==f 
(-)-
V 
. . . .r 
(- -)-
V 
V 


Filgotinib 
GS-US-432-4097
Statistical Analysis Plan – Final Analysis
Version 1.0 
CONFIDENTIAL
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06 October 2021
Appendix 5.
Sample SAS Code for Analysis of Time to Event Endpoints
In the following SAS example codes, aval is the number of weeks from the first dose date to the 
first clinical event or to the censoring date for subjects who don’t have clinical events. Cnsr is a 
binary variable with 1 representing no clinical event observed and 0 representing a clinical event 
observed.
proc lifetest data=analysis;
time aval*cnsr(1);
strata strat1n strat2n/group=trt diff=all test=logrank;
run;
Below SAS example codes are provided for the the proportional hazards model:
proc phreg data=analysis;
class trt (ref = "2");
strata strat1n strat2n;
model aval*cnsr(1)= trt /rl alpha=0.05 ties=efron;
hazardratio trt01pn/alpha=0.05 diff=ref;
run;


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Statistical Analysis Plan – Final Analysis
Version 1.0 
CONFIDENTIAL
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CCI


Filgotinib 
GS-US-432-4097
Statistical Analysis Plan – Final Analysis
Version 1.0 
CONFIDENTIAL
Page 65
06 October 2021
CCI


Filgotinib 
GS-US-432-4097
Statistical Analysis Plan – Final Analysis
Version 1.0 
CONFIDENTIAL
Page 66
06 October 2021
CCI


Filgotinib 
GS-US-432-4097 
Statistical Analysis Plan - Final Analysis 
CONFIDENTIAL 
Page 67 
Version 1.0 
06 October 2021 


Filgotinib 
GS-US-432-4097 
Statistical Analysis Plan - Final Analysis 
CONFIDENTIAL 
Page 68 
Version 1.0 
06 October 2021 


GS-US-432-4097-SAP
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Biostatistics eSigned
08-Oct-2021
07:09:13
Clinical Research eSigned
08-Oct-2021
19:04:54
PPD
PPD