Clinical Trials List
Protocol NumberGS-US-431-4567
NCT Number(ClinicalTrials.gov Identfier)NCT04115839
2019-11-13 - 2021-03-18
Phase III
Terminated6
ICD-10 L40.5
Arthropathic psoriasis
ICD-10L40.52
Psoriatic arthritis mutilans
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy
-
Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
-
Sponsor
Gilead Sciences HK Ltd. Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 紀景琪 Division of General Internal Medicine
- Wen-Hung Chung Division of General Internal Medicine
- Chung-Yao Hsu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳宏安 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Active Psoriatic Arthritis
Objectives
The primary objective of this study is:
• To evaluate the effect of filgotinib compared to placebo in
active psoriatic arthritis (PsA) as assessed by the American
College of Rheumatology 20% improvement (ACR20) response
at Week 12
Secondary objectives of this study are:
• To evaluate the effect of filgotinib on core domains of PsA as
assessed by Minimal Disease Activity (MDA) and Very Low
Disease Activity (VLDA), ACR responses, Psoriasis Area and
Severity Index including Body Surface Area (PASI including
BSA) responses, Spondyloarthritis Research Consortium of
Canada Enthesitis Index and Leeds Enthesitis Index (SPARCC
Enthesitis Index and LEI), Leeds Dactylitis Index (LDI),
Psoriatic Arthritis Disease Activity Score (PASDAS), Disease
Activity Index for Psoriatic Arthritis (DAPSA), Modified Nail
Psoriasis Severity Index (mNAPSI), and Physician’s Global
Assessment of Psoriasis (PhGAP)
• To evaluate the effect of filgotinib on physical function in active
PsA as assessed by Health Assessment Questionnaire –
Disability Index (HAQ-DI)
• To evaluate the effect of filgotinib on fatigue and quality of life
in active PsA as assessed by Functional Assessment of Chronic
Illness Therapy – Fatigue Scale (FACIT-Fatigue), 36-item
Short-Form Health Survey Version 2 (SF-36v2), and 12-item
Psoriatic Arthritis Impact of Disease (PsAID-12)
• To evaluate the safety and tolerability of filgotinib
Test Drug
Filgotinib
Active Ingredient
Filgotinib
Dosage Form
tablet
Dosage
100; 200 mg
Endpoints
Primary Endpoint
The primary endpoint is the ACR20 response at Week 12.
Key Secondary Endpoints
The key secondary endpoints include:
• ACR50 response at Week 12
• Change from Baseline in HAQ-DI at Week 12
• Change from Baseline in SF-36v2 physical component summary (PCS) at Week 16
• Change from Baseline in LEI at Week 16, in subjects with enthesitis at Baseline
• PASI75 response at Week 16, in subjects with psoriasis covering ≥3% of the BSA at
Baseline
• MDA response at Week 16
• Change from Baseline in FACIT-Fatigue at Week 16
• Change from Baseline in LDI at Week 16, in subjects with dactylitis at Baseline
The primary endpoint is the ACR20 response at Week 12.
Key Secondary Endpoints
The key secondary endpoints include:
• ACR50 response at Week 12
• Change from Baseline in HAQ-DI at Week 12
• Change from Baseline in SF-36v2 physical component summary (PCS) at Week 16
• Change from Baseline in LEI at Week 16, in subjects with enthesitis at Baseline
• PASI75 response at Week 16, in subjects with psoriasis covering ≥3% of the BSA at
Baseline
• MDA response at Week 16
• Change from Baseline in FACIT-Fatigue at Week 16
• Change from Baseline in LDI at Week 16, in subjects with dactylitis at Baseline
Inclution Criteria
1) Male or female subjects who are 18-75 years of age (19-75 years of age at sites in
Republic of Korea, 20-75 years of age at sites in Japan and Taiwan) on the day of signing
initial informed consent
2) Meet CASPAR and have a history consistent with PsA ≥6 months at Screening
3) Have active PsA defined as ≥3 swollen joints (from a 66 SJC) and ≥3 tender joints (from a
68 TJC) at Screening and Day 1; these may or may not be the same joints at Screening and
Day 1.
4) Must have a documented history or active signs of at least one of the following at Screening:
a) Plaque psoriasis
b) Nail changes attributed to psoriasis
5) Have had inadequate response (lack of efficacy after ≥12 week duration of therapy) or
intolerance to at least one and not more than 3 bioDMARDs administered for the treatment
of PsA, as per local guidelines / standard of care
6) Prior to the first dose of study drug in this study (Day 1), treatment with bioDMARD(s) for
PsA or psoriasis should have been discontinued as follows:
a) ≥4 weeks prior to Day 1: abatacept, adalimumab, brodalumab, certolizumab pegol,
etanercept, golimumab, ixekizumab, secukinumab
b) ≥8 weeks prior to Day 1: guselkumab, infliximab
c) ≥12 weeks prior to Day 1: ustekinumab, risankizumab
For bioDMARDs not on this list please consult Gilead Medical Monitor or its designee
7) If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum
of 2 of the following drugs and must have been on this treatment for ≥12 consecutive weeks
prior to Screening, with a stable dose and route of administration (defined as no change in
prescription) for ≥4 weeks prior to Day 1:
a) MTX oral or subcutaneous (SC) up to 25 mg / week (must include concomitant use of a
folic / folinic acid supplementation as per local standard of care / investigator judgment;
MTX use may not be combined with leflunomide during the study)
b) Leflunomide up to 20 mg once daily orally (may not be combined with MTX during the
study)
c) Sulfasalazine up to 3 g daily orally
d) Hydroxychloroquine up to 400 mg daily or chloroquine up to 250 mg daily
e) Apremilast up to 30 mg twice daily orally
f) Azathioprine up to 200 mg daily orally
g) Cyclosporine up to 300 mg daily orally
8) If the csDMARD are stopped prior to Day 1, the following washout periods are required.
a) ≥ 4 weeks prior to Day 1: apremilast, sulfasalazine, azathioprine, MTX,
hydroxychloroquine
b) ≥ 8 weeks prior to Day 1: oral cyclosporine
c) Leflunomide must either have a washout period of ≥8 weeks prior to Day 1 or ≥4 weeks
prior to Day 1 if 11 days of standard cholestyramine therapy was completed
9) If taking NSAIDs, dose must be kept stable (defined as no change in prescription) for
≥2 weeks prior to Day 1
10) If taking oral corticosteroids, dose must be ≤ 10mg / day of prednisone or equivalent, and be
kept at a stable dose (defined as no change in prescription) for ≥4 weeks prior to Day 1
11) If using topical therapies for psoriasis (e.g. topical corticosteroids, coal tar, salicylic acid,
vitamin D analogs, retinoids, anthralin, topical calcineurin inhibitors such as tacrolimus) dose
must be stable (defined as no change in prescription) ≥2 weeks prior to Day 1
12) Meet one of the following TB Screening criteria:
a) No evidence of active or latent TB, which is defined as having ALL of the following;
i) A negative QuantiFERON® TB-Gold Plus test at Screening
AND
ii) 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
AND
iii) No history of either untreated or inadequately treated latent or active TB infection
b) For subjects with prior latent TB:
i) A completed course of therapy, as per local standard of care, for latent TB (9 months
of isoniazid in locations where rates of primary multi-drug resistant TB infections are
<5% or an acceptable alternative regimen) WITH a chest X-ray within 3 months prior
to or at Screening.
In these cases, no QuantiFERON® TB-Gold Plus test (or equivalent assay) need be
obtained. A chest radiograph with the report or films must be available for
investigator review.
NOTE: Cases falling under category “b” need to be approved in writing by the Sponsor or its
designee prior to enrollment in the study. Subjects with currently ACTIVE TB are not allowed in
the study, regardless of past or present anti-TB medication use. Subjects with a new diagnosis of
latent TB during screening are not allowed in the study until completion of latent TB treatment is
documented.
13) Able and willing to sign the informed consent, as approved by IRB / IEC. Written consent
must be provided before initiating any screening evaluations. Subjects must have read and
understood the informed consent form (ICF), must fully understand the requirements of the
study, and must be willing to comply with all study visits and assessments. Subjects who
cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
14) Subjects receiving non-prohibited medication for any reason should be on a stable dose
(defined as no change in prescription and stable per investigator judgement) prior to the
first administration of study drug on Day 1
15) A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy
test result at the Day 1 Visit are required for female subjects of child bearing potential
(as defined in Appendix 3)
16) 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 3.
17) Lactating females must agree to discontinue nursing before the study drug is administered.
Republic of Korea, 20-75 years of age at sites in Japan and Taiwan) on the day of signing
initial informed consent
2) Meet CASPAR and have a history consistent with PsA ≥6 months at Screening
3) Have active PsA defined as ≥3 swollen joints (from a 66 SJC) and ≥3 tender joints (from a
68 TJC) at Screening and Day 1; these may or may not be the same joints at Screening and
Day 1.
4) Must have a documented history or active signs of at least one of the following at Screening:
a) Plaque psoriasis
b) Nail changes attributed to psoriasis
5) Have had inadequate response (lack of efficacy after ≥12 week duration of therapy) or
intolerance to at least one and not more than 3 bioDMARDs administered for the treatment
of PsA, as per local guidelines / standard of care
6) Prior to the first dose of study drug in this study (Day 1), treatment with bioDMARD(s) for
PsA or psoriasis should have been discontinued as follows:
a) ≥4 weeks prior to Day 1: abatacept, adalimumab, brodalumab, certolizumab pegol,
etanercept, golimumab, ixekizumab, secukinumab
b) ≥8 weeks prior to Day 1: guselkumab, infliximab
c) ≥12 weeks prior to Day 1: ustekinumab, risankizumab
For bioDMARDs not on this list please consult Gilead Medical Monitor or its designee
7) If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum
of 2 of the following drugs and must have been on this treatment for ≥12 consecutive weeks
prior to Screening, with a stable dose and route of administration (defined as no change in
prescription) for ≥4 weeks prior to Day 1:
a) MTX oral or subcutaneous (SC) up to 25 mg / week (must include concomitant use of a
folic / folinic acid supplementation as per local standard of care / investigator judgment;
MTX use may not be combined with leflunomide during the study)
b) Leflunomide up to 20 mg once daily orally (may not be combined with MTX during the
study)
c) Sulfasalazine up to 3 g daily orally
d) Hydroxychloroquine up to 400 mg daily or chloroquine up to 250 mg daily
e) Apremilast up to 30 mg twice daily orally
f) Azathioprine up to 200 mg daily orally
g) Cyclosporine up to 300 mg daily orally
8) If the csDMARD are stopped prior to Day 1, the following washout periods are required.
a) ≥ 4 weeks prior to Day 1: apremilast, sulfasalazine, azathioprine, MTX,
hydroxychloroquine
b) ≥ 8 weeks prior to Day 1: oral cyclosporine
c) Leflunomide must either have a washout period of ≥8 weeks prior to Day 1 or ≥4 weeks
prior to Day 1 if 11 days of standard cholestyramine therapy was completed
9) If taking NSAIDs, dose must be kept stable (defined as no change in prescription) for
≥2 weeks prior to Day 1
10) If taking oral corticosteroids, dose must be ≤ 10mg / day of prednisone or equivalent, and be
kept at a stable dose (defined as no change in prescription) for ≥4 weeks prior to Day 1
11) If using topical therapies for psoriasis (e.g. topical corticosteroids, coal tar, salicylic acid,
vitamin D analogs, retinoids, anthralin, topical calcineurin inhibitors such as tacrolimus) dose
must be stable (defined as no change in prescription) ≥2 weeks prior to Day 1
12) Meet one of the following TB Screening criteria:
a) No evidence of active or latent TB, which is defined as having ALL of the following;
i) A negative QuantiFERON® TB-Gold Plus test at Screening
AND
ii) 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
AND
iii) No history of either untreated or inadequately treated latent or active TB infection
b) For subjects with prior latent TB:
i) A completed course of therapy, as per local standard of care, for latent TB (9 months
of isoniazid in locations where rates of primary multi-drug resistant TB infections are
<5% or an acceptable alternative regimen) WITH a chest X-ray within 3 months prior
to or at Screening.
In these cases, no QuantiFERON® TB-Gold Plus test (or equivalent assay) need be
obtained. A chest radiograph with the report or films must be available for
investigator review.
NOTE: Cases falling under category “b” need to be approved in writing by the Sponsor or its
designee prior to enrollment in the study. Subjects with currently ACTIVE TB are not allowed in
the study, regardless of past or present anti-TB medication use. Subjects with a new diagnosis of
latent TB during screening are not allowed in the study until completion of latent TB treatment is
documented.
13) Able and willing to sign the informed consent, as approved by IRB / IEC. Written consent
must be provided before initiating any screening evaluations. Subjects must have read and
understood the informed consent form (ICF), must fully understand the requirements of the
study, and must be willing to comply with all study visits and assessments. Subjects who
cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
14) Subjects receiving non-prohibited medication for any reason should be on a stable dose
(defined as no change in prescription and stable per investigator judgement) prior to the
first administration of study drug on Day 1
15) A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy
test result at the Day 1 Visit are required for female subjects of child bearing potential
(as defined in Appendix 3)
16) 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 3.
17) Lactating females must agree to discontinue nursing before the study drug is administered.
Exclusion Criteria
1) Known hypersensitivity to the study drug, the metabolites, or formulation excipients
2) Prior PsA or psoriasis treatment with ≥4 bioDMARDs
3) Prior exposure to a JAK inhibitor >2 doses
4) Corticosteroid use as follows:
a) Intra-articular corticosteroids ≤8 weeks of Day 1
b) Parenteral or topical corticosteroids ≤ 2 weeks of Day 1
5) Use of any of the following treatments ≤4 weeks of Day 1:
a) Intra-articular injection of hyaluronate therapies
b) Oral retinoids (including tazarotene)
c) Phototherapy (UVA or UVB) with or without psoralens or self-treatment with sunbathing
or tanning beds
d) Potent P-glycoprotein (P-gp) inducer (e.g. carbamazepine, clotrimazole, dexamethasone,
phenothiazine, phenytoin, retinoic acid, rifampin, St. John’s wort and venlafaxine)
e) Oral or injectable gold
f) D-penicillamine
g) Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other
alkylating agents
6) Any moderately to severely active, musculoskeletal or skin disorder other than PsA or plaque
psoriasis that would interfere with assessment of study parameters as per judgment of
investigator
NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is
documentation of change in diagnosis to PsA or additional diagnosis of PsA.
7) Any history of an inflammatory arthropathy with onset before age 16 years old
8) Active autoimmune disease that would interfere with assessment of study parameters or
increase risk to the subject by participating in the study, (e.g., uveitis, inflammatory bowel
disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of
investigator.
9) Presence of any extra-articular manifestations typically associated with RA, such as
rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of
investigator
10) Have undergone surgical treatments for PsA, including synovectomy or arthroplasty in
> 4 joints and / or ≤12 weeks prior to Day 1
11) History of major surgery (requiring regional block or general anesthesia) ≤3 months prior to
Screening or planned major surgery during the study
12) Administration of a live / attenuated vaccine ≤30 days prior to Day 1, or planned during the
study
13) Participation in any clinical study of an investigational drug / device ≤4 weeks or 5 half-lives
prior to Screening, whichever is longer. Exposure to investigational biologics must be
discussed with the Sponsor with written approval.
14) History of or current moderate to severe congestive heart failure (New York Heart
Association [NYHA] class III or IV), or within the last 6 months, a cerebrovascular accident,
myocardial infarction, unstable angina, unstable arrhythmia, new or significant ECG finding
at Screening, or any other cardiovascular condition which, in the opinion of the investigator,
would put the subject at risk by participation in the study
15) History of malignancy ≤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)
16) History of lymphoproliferative disease or current lymphoproliferative disease
17) History of organ or bone marrow transplant
18) History of gastrointestinal perforation
19) Positive serology for human immunodeficiency virus (HIV) 1 or 2
20) Evidence of active HCV infection. Subjects with positive HCV Antibody (Ab) at Screening,
require reflex testing for HCV RNA. Subjects with positive HCV RNA viral load (VL) at
Screening will be excluded. Subjects with positive HCV Ab, but negative HCV RNA VL are
eligible per investigator judgment, but require ongoing monitoring as outlined in the Study
Procedures Table (Appendix 2).
21) Evidence of active HBV infection. Subjects with positive HBV 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 as outlined in the Study Procedures Table (Appendix 2).
22) History of opportunistic infection, or immunodeficiency syndrome, which would put the
subject at risk, as per investigator judgment
23) Active infection that is clinically significant, as per judgment of the investigator, or any
infection requiring hospitalization or treatment with intravenous anti-infectives ≤60 days of
Screening; or any infection requiring oral anti-infective therapy ≤2 weeks before Day 1
24) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus,
herpes zoster, and atypical mycobacteria)
25) History of disseminated staphylococcus aureus or disseminated herpes simplex infection
26) History of symptomatic herpes zoster infection ≤12 weeks prior to Screening or have history
of disseminated / complicated herpes zoster infection (multi-dermatomal involvement,
ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
27) History of an infected joint prosthesis or other implanted device with retention of the
prosthesis or device in situ
28) Current tobacco, alcohol, or substance abuse, per investigator judgement.
29) Active fibromyalgia or other disorder that based on the investigator’s opinion would make it
difficult to appropriately assess PsA activity for the purposes of this study
30) Any chronic, uncontrolled medical condition, which would put the subject at increased risk
during study participation including but not limited to: diabetes, hypertension, morbid
obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurological and / or psychiatric disease
or other disease of concern, or circumstances which may make a subject unlikely or unable to
complete or comply with study procedures and requirements, as per investigator judgement
31) Ongoing suicidal ideation or history of suicide attempt ≤20 years of Screening
32) Significant blood loss (>450 mL) or transfusion of any blood product ≤12 weeks prior to
Day 1
33) Central laboratory tests at Screening that meet any of the criteria below:
a) Hemoglobin <8.0g / dL (SI: <80g / 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) ALT or AST ≥1.5 x ULN
g) Total bilirubin level ≥1.5 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 Cockroft Gault formula
NOTE: Before subject is considered a screen-failure, out of range lab values may be rechecked
one time after consultation with the Sponsor or designee. Written approval must be obtained.
34) Subject is unwilling or unable to follow protocol requirements
2) Prior PsA or psoriasis treatment with ≥4 bioDMARDs
3) Prior exposure to a JAK inhibitor >2 doses
4) Corticosteroid use as follows:
a) Intra-articular corticosteroids ≤8 weeks of Day 1
b) Parenteral or topical corticosteroids ≤ 2 weeks of Day 1
5) Use of any of the following treatments ≤4 weeks of Day 1:
a) Intra-articular injection of hyaluronate therapies
b) Oral retinoids (including tazarotene)
c) Phototherapy (UVA or UVB) with or without psoralens or self-treatment with sunbathing
or tanning beds
d) Potent P-glycoprotein (P-gp) inducer (e.g. carbamazepine, clotrimazole, dexamethasone,
phenothiazine, phenytoin, retinoic acid, rifampin, St. John’s wort and venlafaxine)
e) Oral or injectable gold
f) D-penicillamine
g) Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other
alkylating agents
6) Any moderately to severely active, musculoskeletal or skin disorder other than PsA or plaque
psoriasis that would interfere with assessment of study parameters as per judgment of
investigator
NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is
documentation of change in diagnosis to PsA or additional diagnosis of PsA.
7) Any history of an inflammatory arthropathy with onset before age 16 years old
8) Active autoimmune disease that would interfere with assessment of study parameters or
increase risk to the subject by participating in the study, (e.g., uveitis, inflammatory bowel
disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of
investigator.
9) Presence of any extra-articular manifestations typically associated with RA, such as
rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of
investigator
10) Have undergone surgical treatments for PsA, including synovectomy or arthroplasty in
> 4 joints and / or ≤12 weeks prior to Day 1
11) History of major surgery (requiring regional block or general anesthesia) ≤3 months prior to
Screening or planned major surgery during the study
12) Administration of a live / attenuated vaccine ≤30 days prior to Day 1, or planned during the
study
13) Participation in any clinical study of an investigational drug / device ≤4 weeks or 5 half-lives
prior to Screening, whichever is longer. Exposure to investigational biologics must be
discussed with the Sponsor with written approval.
14) History of or current moderate to severe congestive heart failure (New York Heart
Association [NYHA] class III or IV), or within the last 6 months, a cerebrovascular accident,
myocardial infarction, unstable angina, unstable arrhythmia, new or significant ECG finding
at Screening, or any other cardiovascular condition which, in the opinion of the investigator,
would put the subject at risk by participation in the study
15) History of malignancy ≤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)
16) History of lymphoproliferative disease or current lymphoproliferative disease
17) History of organ or bone marrow transplant
18) History of gastrointestinal perforation
19) Positive serology for human immunodeficiency virus (HIV) 1 or 2
20) Evidence of active HCV infection. Subjects with positive HCV Antibody (Ab) at Screening,
require reflex testing for HCV RNA. Subjects with positive HCV RNA viral load (VL) at
Screening will be excluded. Subjects with positive HCV Ab, but negative HCV RNA VL are
eligible per investigator judgment, but require ongoing monitoring as outlined in the Study
Procedures Table (Appendix 2).
21) Evidence of active HBV infection. Subjects with positive HBV 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 as outlined in the Study Procedures Table (Appendix 2).
22) History of opportunistic infection, or immunodeficiency syndrome, which would put the
subject at risk, as per investigator judgment
23) Active infection that is clinically significant, as per judgment of the investigator, or any
infection requiring hospitalization or treatment with intravenous anti-infectives ≤60 days of
Screening; or any infection requiring oral anti-infective therapy ≤2 weeks before Day 1
24) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus,
herpes zoster, and atypical mycobacteria)
25) History of disseminated staphylococcus aureus or disseminated herpes simplex infection
26) History of symptomatic herpes zoster infection ≤12 weeks prior to Screening or have history
of disseminated / complicated herpes zoster infection (multi-dermatomal involvement,
ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
27) History of an infected joint prosthesis or other implanted device with retention of the
prosthesis or device in situ
28) Current tobacco, alcohol, or substance abuse, per investigator judgement.
29) Active fibromyalgia or other disorder that based on the investigator’s opinion would make it
difficult to appropriately assess PsA activity for the purposes of this study
30) Any chronic, uncontrolled medical condition, which would put the subject at increased risk
during study participation including but not limited to: diabetes, hypertension, morbid
obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurological and / or psychiatric disease
or other disease of concern, or circumstances which may make a subject unlikely or unable to
complete or comply with study procedures and requirements, as per investigator judgement
31) Ongoing suicidal ideation or history of suicide attempt ≤20 years of Screening
32) Significant blood loss (>450 mL) or transfusion of any blood product ≤12 weeks prior to
Day 1
33) Central laboratory tests at Screening that meet any of the criteria below:
a) Hemoglobin <8.0g / dL (SI: <80g / 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) ALT or AST ≥1.5 x ULN
g) Total bilirubin level ≥1.5 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 Cockroft Gault formula
NOTE: Before subject is considered a screen-failure, out of range lab values may be rechecked
one time after consultation with the Sponsor or designee. Written approval must be obtained.
34) Subject is unwilling or unable to follow protocol requirements
The Estimated Number of Participants
-
Taiwan
1 participants
-
Global
106 participants
