Clinical Trials List
Protocol NumberI4V-MC-JAHA
NCT Number(ClinicalTrials.gov Identfier)2016-004675-52 (EudraCT Number)
2017-07-01 - 2022-01-01
Phase III
Not yet recruiting8
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-9696.8
Other psoriasis and similar disorders
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study Followed by Long-Term Treatment for Evaluation of Efficacy and Safety of Baricitinib in Patients with Active Psoriatic Arthritis
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 洪偉哲 風濕免疫科
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- 蔡嘉哲 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 謝佳偉 Division of Rheumatology
- 林靖才 Division of Rheumatology
- 賴國隆 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
- 謝祖怡 Division of Rheumatology
- 洪維廷 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Co-Principal Investigator
- Joung-Liang Lan 未分科
Audit
None
Linkou Chang Gung Medical Foundation
Taiwan National PI
黃毓惠
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
- Ya-Ching Chang Division of Dermatology
- Chang-Fu Kuo Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Co-Principal Investigator
- 邱顯鎰 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Audit
None
Condition/Disease
Psoriatic Arthritis
Objectives
Primary
• To compare the efficacy of baricitinib 4 mg QD versus placebo at Week 16 in the overall study population
Major Secondary
• To compare baricitinib 4 mg QD to placebo at Week 16 in the overall study population
• To compare baricitinib 2 mg QD to placebo at Week 16 in the overall study population
• To compare baricitinib 4 mg QD to placebo at Week 16 in the subgroup of bDMARD-naïve patients
• To compare baricitinib 4 mg QD to placebo at Week 24 in the overall study population
• To compare baricitinib 4 mg QD to placebo at Week 16 in the overall study population
Test Drug
Baricitinib (LY3009104)
Active Ingredient
Baricitinib (LY3009104)
Dosage Form
tablet
Dosage
2mg/4mg
Endpoints
Primary Endpoints
• Proportion of patients achieving an ACR20 response
Secondary Endpoints
• Change from baseline in HAQ-DI scores
• Proportion of patients achieving an ACR20 response
• Change from baseline in HAQ-DI
• Proportion of patients achieving an ACR20 response
• Change from baseline in HAQ-DI
• Change from baseline in mTSS
• Proportion of patients achieving PASI75 response (in the subgroup of patients with baseline psoriatic lesion involving ≥3% body surface area [BSA])
• Proportion of patients achieving MDAPASI
• Change from baseline in SPARCC Enthesitis Index in the subgroup of patients with enthesitis at baseline
• Change from baseline in LDI-B in the subgroup of patients with dactylitis at baseline
• Proportion of patients achieving an ACR20 response
Secondary Endpoints
• Change from baseline in HAQ-DI scores
• Proportion of patients achieving an ACR20 response
• Change from baseline in HAQ-DI
• Proportion of patients achieving an ACR20 response
• Change from baseline in HAQ-DI
• Change from baseline in mTSS
• Proportion of patients achieving PASI75 response (in the subgroup of patients with baseline psoriatic lesion involving ≥3% body surface area [BSA])
• Proportion of patients achieving MDAPASI
• Change from baseline in SPARCC Enthesitis Index in the subgroup of patients with enthesitis at baseline
• Change from baseline in LDI-B in the subgroup of patients with dactylitis at baseline
Inclution Criteria
Inclusion Criteria
Type of Patient and Disease Characteristics
[1] are adults aged 18 years or older at the time of consent
[2] have an established diagnosis of PsA for ≥6 months and currently meet the
CASPAR criteria (Appendix 5)
[3] have active PsA defined as the presence of at least 3/68 tender and at least
3/66 swollen joints (at Visit 1 and Visit 2)
Note: If significant surgical treatment of a joint has been performed, that joint
cannot be counted in the TJC or SJC for enrollment purposes.
[4] have active plaque psoriatic skin lesion
[5] have at least 1 joint erosion on hand or foot x-rays as determined by the
central reader OR have a hsCRP ≥6 mg/L (0.6 mg/dL) at screening.
The hsCRP measurement may be repeated once during screening, and values
resulting from repeat testing may be accepted for enrollment eligibility if they
meet the eligibility criterion.
[6] patients must be categorized into 1 of the following 2 strata:
a bDMARD-naïve: patients who have active PsA despite current or prior
NSAIDs or cDMARDs and have never received bDMARD treatment, or
b TNF-IR: have been treated at approved doses with at least 1 TNFi (for
example, adalimumab, certolizumab, golimumab, etanercept, infliximab)
for at least 12 weeks and in the opinion of the investigator either:
o experienced insufficient efficacy or loss of efficacy at a dose that,
in accordance with local clinical practice, is considered acceptable
to adequately assess clinical response or
o experienced intolerance of such treatment (the 12 weeks treatment
period with TNFi is not required in case of intolerance)
Patient Characteristics
[7] Male or nonpregnant, nonbreastfeeding female patient
a Male patients must agree to use 2 forms of birth control (one must be
highly effective, see below) while engaging in sexual intercourse with
female partners of childbearing potential while enrolled in the study and
for at least 4 weeks following the last dose of investigational product
b Female patients of childbearing potential must agree to use 2 forms of
birth control, when engaging in sexual intercourse with a male partner
while enrolled in the study and for at least 4 weeks following the last dose
of investigational product
The following birth control methods are considered acceptable (the patient
should choose 2 to be used with their male partner, and 1 must be
highly effective):
o Highly effective birth control methods: oral, injectable, or
implanted hormonal contraceptives (combined
estrogen/progesterone or progesterone only, associated with
inhibition of ovulation); intrauterine device or intrauterine system
(for example, progestin-releasing coil); or, vasectomized male
(with appropriate post-vasectomy documentation of the absence of
sperm in the ejaculate).
o Effective birth control methods: condom with a spermicidal foam,
gel, film, cream, or suppository; occlusive cap (diaphragm or
cervical/vault caps) with a spermicidal foam, gel, film, cream, or
suppository; or, oral hormonal contraceptives.
Note: When local guidelines concerning highly effective or effective
methods of birth control differ from the above, the local guidelines
must be followed.
c Females of nonchildbearing potential are not required to use birth control
and they are defined as
o women ≥60 years of age or women who are congenitally sterile, or
o women ≥40 and <60 years of age who have had a cessation of menses
for ≥12 months and a follicle-stimulating hormone (FSH) test
confirming nonchildbearing potential (≥40 mIU/mL or ≥40 IU/L), or
o women who are surgically sterile (that is, have had a hysterectomy or
bilateral oophorectomy or tubal ligation)
Informed Consent
[8] must read and understand the informed consent approved by Eli Lilly and
Company (Lilly), or its designee, and the institutional review board
(IRB)/ethics review board (ERB) governing the site, and provide written
informed consent.
Type of Patient and Disease Characteristics
[1] are adults aged 18 years or older at the time of consent
[2] have an established diagnosis of PsA for ≥6 months and currently meet the
CASPAR criteria (Appendix 5)
[3] have active PsA defined as the presence of at least 3/68 tender and at least
3/66 swollen joints (at Visit 1 and Visit 2)
Note: If significant surgical treatment of a joint has been performed, that joint
cannot be counted in the TJC or SJC for enrollment purposes.
[4] have active plaque psoriatic skin lesion
[5] have at least 1 joint erosion on hand or foot x-rays as determined by the
central reader OR have a hsCRP ≥6 mg/L (0.6 mg/dL) at screening.
The hsCRP measurement may be repeated once during screening, and values
resulting from repeat testing may be accepted for enrollment eligibility if they
meet the eligibility criterion.
[6] patients must be categorized into 1 of the following 2 strata:
a bDMARD-naïve: patients who have active PsA despite current or prior
NSAIDs or cDMARDs and have never received bDMARD treatment, or
b TNF-IR: have been treated at approved doses with at least 1 TNFi (for
example, adalimumab, certolizumab, golimumab, etanercept, infliximab)
for at least 12 weeks and in the opinion of the investigator either:
o experienced insufficient efficacy or loss of efficacy at a dose that,
in accordance with local clinical practice, is considered acceptable
to adequately assess clinical response or
o experienced intolerance of such treatment (the 12 weeks treatment
period with TNFi is not required in case of intolerance)
Patient Characteristics
[7] Male or nonpregnant, nonbreastfeeding female patient
a Male patients must agree to use 2 forms of birth control (one must be
highly effective, see below) while engaging in sexual intercourse with
female partners of childbearing potential while enrolled in the study and
for at least 4 weeks following the last dose of investigational product
b Female patients of childbearing potential must agree to use 2 forms of
birth control, when engaging in sexual intercourse with a male partner
while enrolled in the study and for at least 4 weeks following the last dose
of investigational product
The following birth control methods are considered acceptable (the patient
should choose 2 to be used with their male partner, and 1 must be
highly effective):
o Highly effective birth control methods: oral, injectable, or
implanted hormonal contraceptives (combined
estrogen/progesterone or progesterone only, associated with
inhibition of ovulation); intrauterine device or intrauterine system
(for example, progestin-releasing coil); or, vasectomized male
(with appropriate post-vasectomy documentation of the absence of
sperm in the ejaculate).
o Effective birth control methods: condom with a spermicidal foam,
gel, film, cream, or suppository; occlusive cap (diaphragm or
cervical/vault caps) with a spermicidal foam, gel, film, cream, or
suppository; or, oral hormonal contraceptives.
Note: When local guidelines concerning highly effective or effective
methods of birth control differ from the above, the local guidelines
must be followed.
c Females of nonchildbearing potential are not required to use birth control
and they are defined as
o women ≥60 years of age or women who are congenitally sterile, or
o women ≥40 and <60 years of age who have had a cessation of menses
for ≥12 months and a follicle-stimulating hormone (FSH) test
confirming nonchildbearing potential (≥40 mIU/mL or ≥40 IU/L), or
o women who are surgically sterile (that is, have had a hysterectomy or
bilateral oophorectomy or tubal ligation)
Informed Consent
[8] must read and understand the informed consent approved by Eli Lilly and
Company (Lilly), or its designee, and the institutional review board
(IRB)/ethics review board (ERB) governing the site, and provide written
informed consent.
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from study enrollment if they meet any of the following criteria at
screening (Visit 1):
Medical Conditions Related to PsA
[9] have autoimmune or inflammatory conditions other than PsA that might
confound the evaluation of the benefit of baricitinib therapy
a have a history of RA, juvenile idiopathic arthritis, ankylosing spondylitis,
reactive arthritis, systemic lupus erythematosus, vasculitis, gout, or Felty’s
syndrome, as examples.
b have active Crohn’s disease (CD) or active ulcerative colitis (UC).
Note: Patients may be enrolled if they have had a history of inflammatory
bowel disease, including CD and UC, but have had no exacerbation for
≥6 months prior to baseline randomization and, if currently on
treatment, must be on stable treatment for ≥6 months prior to baseline
randomization.
c have active anterior uveitis (an acute episode) within the last 42 days prior
to baseline randomization.
[10] have a history of drug-induced psoriasis
[11] have active fibromyalgia or other chronic pain conditions that, in the
investigator’s opinion, would make it difficult to appropriately assess disease
activity for the purposes of this study
[12] have been treated with the following therapies:
a received a bDMARD treatment for PsA such as adalimumab,
certolizumab, etanercept, golimumab, abatacept, tocilizumab, ixekizumab,
secukinumab, or ustekinumab within 4 weeks of planned randomization;
or received rituximab within 6 months of planned randomization
b received any JAK inhibitors (including, but not limited to, tofacitinib or
baricitinib) previously or concurrently
c received denosumab within the prior 12 months
d received phosphodiesterase-4 inhibitors (apremilast) within 4 weeks of
planned randomization
[13] Have been treated with cDMARDs in the following situations:
a received the following 4 cDMARDs on an unstable dose or exceeding the
maximum dose (as below) within 4 weeks prior to randomization:
o methotrexate (MTX) = 25 mg/week (and local standard of care
should be followed for concomitant administration of folic acid with
MTX)
o leflunomide (LEF) = 20 mg/day
o sulfasalazine (SSZ) = 3 g/day
o hydroxychloroquine (HCQ) = 400 mg/day
b received cDMARDs such as cyclosporine, azathioprine or gold salts (other
than MTX, SSZ, LEF, or HCQ) within 4 weeks of planned randomization
c received concomitant combination of more than 2 cDMARDs within
4 weeks of planned randomization
d discontinued MTX or SSZ or HCQ within 4 weeks or LEF within
12 weeks (or 4 weeks, if patients undergo standard 11-day cholestyramine
washout for LEF) prior to randomization
[14] have used any NSAIDs on an unstable dose within 2 weeks of study entry or
within 4 weeks of randomization
[15] have used any analgesics on an unstable dose within 2 weeks of study entry or
within 4 weeks of randomization
[16] have been treated with corticosteroid in the following situations:
a received oral corticosteroids on an unstable dose or at a dose >10 mg/day
prednisone (or equivalent) within 2 weeks of study entry or within
4 weeks of randomization
b received any parenteral corticosteroid administered by intramuscular or
intravenous (IV) injection within 2 weeks of study entry or within
4 weeks of randomization, or anticipating a parenteral injection of
corticosteroids during the Double-Blind Placebo-Controlled Treatment
Period (Period 2) of the study
c have had 3 or more joints injected with intraarticular corticosteroids or
hyaluronic acid within 2 weeks of study entry or within 4 weeks of
randomization
o Joints injected with intraarticular corticosteroids or hyaluronic acid
within 2 weeks of study entry or within 4 weeks of randomization
cannot be counted in the TJC and SJC for entry or enrollment
purposes.
[17] have had surgical treatment of a joint within 8 weeks prior to baseline or will
require such treatment prior to Week 24 (Visit 10), or have had a joint injected
with intra-articular hyaluronic acid within 2 weeks of study entry or within
4 weeks of randomization
[18] have received the following therapies for psoriasis:
a systemic use of oral retinoids, thioguanine, hydroxyurea, or fumaric acid
derivatives, within 4 weeks of planned randomization
b photochemotherapy using oral psoralens and ultraviolet A radiation
within 4 weeks of planned randomization
c phototherapy, including ultraviolet A, ultraviolet B, or self-treatment
with tanning beds within 2 weeks of planned randomization
d topical psoriasis treatment within the 2 weeks prior to randomization.
Exceptions: weak potency (World Health Organization [WHO] Group 1
classification) topical corticosteroids will be permitted.
Medical Conditions in General
[19] are largely or wholly incapacitated, permitting little or no self-care such as
being bedridden or confined to wheelchair
[20] in the opinion of the investigator, are at an unacceptable risk by participating
in the study
[21] have a history or presence of cardiovascular, respiratory, renal, hepatic,
gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric
disorders or any other serious and/or unstable illness that, in the opinion of the
investigator, could constitute an unacceptable risk when taking investigational
product or interfere with the interpretation of data
[22] have experienced any of the following within 12 weeks of screening:
myocardial infarction, unstable ischemic heart disease, cerebrovascular
accident, or moderate-to-severe heart failure (New York Heart Association
Class III/IV)
[23] have a known immunodeficiency or are immunocompromised to an extent
such that participation in the study would pose an unacceptable risk to the
patient
[24] have a history of lymphoproliferative disease; have signs or symptoms
suggestive of possible lymphoproliferative disease, including
lymphadenopathy or splenomegaly; have active primary or recurrent
malignant disease; or have been in remission from clinically significant
malignancy for <5 years prior to randomization.
The following may be exempted:
a Patients with cervical carcinoma in situ that has been resected with no
evidence of recurrence or metastatic disease for at least 3 years may
participate in the study.
b Patients with basal cell or squamous epithelial skin cancers that have been
completely resected with no evidence of recurrence for at least 3 years
may participate in the study.
[25] have a history of chronic liver disease with the most recent available aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) >2.0x upper limit
of normal (ULN) or total bilirubin level (TBL) ≥1.5x ULN (if available)
[26] have had any major surgery within 8 weeks prior to screening or will require
major surgery during the study that, in the opinion of the investigator in
consultation with Lilly or its designee, would pose an unacceptable risk to the
patient
[27] have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection, including but not limited to the following:
a symptomatic herpes zoster infection within 12 weeks prior to
randomization
b a history of disseminated/complicated herpes zoster (for example,
multidermatomal involvement, ophthalmic zoster, central nervous system
including central cranial nerve involvement, or post-herpetic neuralgia)
c symptomatic herpes simplex at the time of randomization
d active or chronic viral infection from hepatitis B virus (HBV), hepatitis C
virus (HCV), or human immunodeficiency virus (HIV)
e household contact with a person with active tuberculosis (TB) and did not
receive appropriate and documented prophylaxis for TB
f evidence of active TB or have previously had evidence of active TB and
did not receive appropriate and documented treatment
g clinically serious infection or received intravenous antibiotics for an
infection, within the past 4 weeks of randomization
h any other active or recent infection within 4 weeks of randomization that,
in the opinion of the investigator, would pose an unacceptable risk to the
patient if participating in the study.
[28] have been exposed to a live vaccine within 12 weeks prior to randomization or
are expected to need/receive a live vaccine during the course of the study
(with the exception of herpes zoster vaccination)
Note: All patients who have not previously received the herpes zoster vaccine
by screening will be encouraged (per local guidelines) to do so prior to
randomization; vaccination with live herpes zoster vaccine must occur
>4 weeks prior to randomization and start of investigational product.
Patients will not be randomized if they were exposed to a live herpes
zoster vaccination within 4 weeks of planned randomization. Investigators
should review the vaccination status of their patients and follow the local
guidelines for vaccination of patients ≥18 years of age with nonlive
vaccines intended to prevent infectious disease prior to entering patients
into the study.
[29] have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug
abuse within the 2 years prior to screening; or concurrent cannabinoid use at
the screening and within 4 weeks prior to randomization
[30] have significant uncontrolled neuropsychiatric disorder; have a recent history
of a suicide attempt (60 days within screening visit [Visit 1] and any time
between screening visit [Visit 1] and baseline randomization [Visit 2]); or
have a score of 3 on Item 12 (Thoughts of Death or Suicide) of the Quick
Inventory of Depressive Symptomatology-Self-Report, 16 Items (QIDSSR16) at screening or baseline or are clinically judged by the investigator to
be at risk for suicide
[31] have donated more than a single unit of blood within 4 weeks prior to
screening or intend to donate blood during the course of the study
Patients will be excluded from study enrollment if they meet any of the following criteria at
screening (Visit 1):
Medical Conditions Related to PsA
[9] have autoimmune or inflammatory conditions other than PsA that might
confound the evaluation of the benefit of baricitinib therapy
a have a history of RA, juvenile idiopathic arthritis, ankylosing spondylitis,
reactive arthritis, systemic lupus erythematosus, vasculitis, gout, or Felty’s
syndrome, as examples.
b have active Crohn’s disease (CD) or active ulcerative colitis (UC).
Note: Patients may be enrolled if they have had a history of inflammatory
bowel disease, including CD and UC, but have had no exacerbation for
≥6 months prior to baseline randomization and, if currently on
treatment, must be on stable treatment for ≥6 months prior to baseline
randomization.
c have active anterior uveitis (an acute episode) within the last 42 days prior
to baseline randomization.
[10] have a history of drug-induced psoriasis
[11] have active fibromyalgia or other chronic pain conditions that, in the
investigator’s opinion, would make it difficult to appropriately assess disease
activity for the purposes of this study
[12] have been treated with the following therapies:
a received a bDMARD treatment for PsA such as adalimumab,
certolizumab, etanercept, golimumab, abatacept, tocilizumab, ixekizumab,
secukinumab, or ustekinumab within 4 weeks of planned randomization;
or received rituximab within 6 months of planned randomization
b received any JAK inhibitors (including, but not limited to, tofacitinib or
baricitinib) previously or concurrently
c received denosumab within the prior 12 months
d received phosphodiesterase-4 inhibitors (apremilast) within 4 weeks of
planned randomization
[13] Have been treated with cDMARDs in the following situations:
a received the following 4 cDMARDs on an unstable dose or exceeding the
maximum dose (as below) within 4 weeks prior to randomization:
o methotrexate (MTX) = 25 mg/week (and local standard of care
should be followed for concomitant administration of folic acid with
MTX)
o leflunomide (LEF) = 20 mg/day
o sulfasalazine (SSZ) = 3 g/day
o hydroxychloroquine (HCQ) = 400 mg/day
b received cDMARDs such as cyclosporine, azathioprine or gold salts (other
than MTX, SSZ, LEF, or HCQ) within 4 weeks of planned randomization
c received concomitant combination of more than 2 cDMARDs within
4 weeks of planned randomization
d discontinued MTX or SSZ or HCQ within 4 weeks or LEF within
12 weeks (or 4 weeks, if patients undergo standard 11-day cholestyramine
washout for LEF) prior to randomization
[14] have used any NSAIDs on an unstable dose within 2 weeks of study entry or
within 4 weeks of randomization
[15] have used any analgesics on an unstable dose within 2 weeks of study entry or
within 4 weeks of randomization
[16] have been treated with corticosteroid in the following situations:
a received oral corticosteroids on an unstable dose or at a dose >10 mg/day
prednisone (or equivalent) within 2 weeks of study entry or within
4 weeks of randomization
b received any parenteral corticosteroid administered by intramuscular or
intravenous (IV) injection within 2 weeks of study entry or within
4 weeks of randomization, or anticipating a parenteral injection of
corticosteroids during the Double-Blind Placebo-Controlled Treatment
Period (Period 2) of the study
c have had 3 or more joints injected with intraarticular corticosteroids or
hyaluronic acid within 2 weeks of study entry or within 4 weeks of
randomization
o Joints injected with intraarticular corticosteroids or hyaluronic acid
within 2 weeks of study entry or within 4 weeks of randomization
cannot be counted in the TJC and SJC for entry or enrollment
purposes.
[17] have had surgical treatment of a joint within 8 weeks prior to baseline or will
require such treatment prior to Week 24 (Visit 10), or have had a joint injected
with intra-articular hyaluronic acid within 2 weeks of study entry or within
4 weeks of randomization
[18] have received the following therapies for psoriasis:
a systemic use of oral retinoids, thioguanine, hydroxyurea, or fumaric acid
derivatives, within 4 weeks of planned randomization
b photochemotherapy using oral psoralens and ultraviolet A radiation
within 4 weeks of planned randomization
c phototherapy, including ultraviolet A, ultraviolet B, or self-treatment
with tanning beds within 2 weeks of planned randomization
d topical psoriasis treatment within the 2 weeks prior to randomization.
Exceptions: weak potency (World Health Organization [WHO] Group 1
classification) topical corticosteroids will be permitted.
Medical Conditions in General
[19] are largely or wholly incapacitated, permitting little or no self-care such as
being bedridden or confined to wheelchair
[20] in the opinion of the investigator, are at an unacceptable risk by participating
in the study
[21] have a history or presence of cardiovascular, respiratory, renal, hepatic,
gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric
disorders or any other serious and/or unstable illness that, in the opinion of the
investigator, could constitute an unacceptable risk when taking investigational
product or interfere with the interpretation of data
[22] have experienced any of the following within 12 weeks of screening:
myocardial infarction, unstable ischemic heart disease, cerebrovascular
accident, or moderate-to-severe heart failure (New York Heart Association
Class III/IV)
[23] have a known immunodeficiency or are immunocompromised to an extent
such that participation in the study would pose an unacceptable risk to the
patient
[24] have a history of lymphoproliferative disease; have signs or symptoms
suggestive of possible lymphoproliferative disease, including
lymphadenopathy or splenomegaly; have active primary or recurrent
malignant disease; or have been in remission from clinically significant
malignancy for <5 years prior to randomization.
The following may be exempted:
a Patients with cervical carcinoma in situ that has been resected with no
evidence of recurrence or metastatic disease for at least 3 years may
participate in the study.
b Patients with basal cell or squamous epithelial skin cancers that have been
completely resected with no evidence of recurrence for at least 3 years
may participate in the study.
[25] have a history of chronic liver disease with the most recent available aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) >2.0x upper limit
of normal (ULN) or total bilirubin level (TBL) ≥1.5x ULN (if available)
[26] have had any major surgery within 8 weeks prior to screening or will require
major surgery during the study that, in the opinion of the investigator in
consultation with Lilly or its designee, would pose an unacceptable risk to the
patient
[27] have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection, including but not limited to the following:
a symptomatic herpes zoster infection within 12 weeks prior to
randomization
b a history of disseminated/complicated herpes zoster (for example,
multidermatomal involvement, ophthalmic zoster, central nervous system
including central cranial nerve involvement, or post-herpetic neuralgia)
c symptomatic herpes simplex at the time of randomization
d active or chronic viral infection from hepatitis B virus (HBV), hepatitis C
virus (HCV), or human immunodeficiency virus (HIV)
e household contact with a person with active tuberculosis (TB) and did not
receive appropriate and documented prophylaxis for TB
f evidence of active TB or have previously had evidence of active TB and
did not receive appropriate and documented treatment
g clinically serious infection or received intravenous antibiotics for an
infection, within the past 4 weeks of randomization
h any other active or recent infection within 4 weeks of randomization that,
in the opinion of the investigator, would pose an unacceptable risk to the
patient if participating in the study.
[28] have been exposed to a live vaccine within 12 weeks prior to randomization or
are expected to need/receive a live vaccine during the course of the study
(with the exception of herpes zoster vaccination)
Note: All patients who have not previously received the herpes zoster vaccine
by screening will be encouraged (per local guidelines) to do so prior to
randomization; vaccination with live herpes zoster vaccine must occur
>4 weeks prior to randomization and start of investigational product.
Patients will not be randomized if they were exposed to a live herpes
zoster vaccination within 4 weeks of planned randomization. Investigators
should review the vaccination status of their patients and follow the local
guidelines for vaccination of patients ≥18 years of age with nonlive
vaccines intended to prevent infectious disease prior to entering patients
into the study.
[29] have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug
abuse within the 2 years prior to screening; or concurrent cannabinoid use at
the screening and within 4 weeks prior to randomization
[30] have significant uncontrolled neuropsychiatric disorder; have a recent history
of a suicide attempt (60 days within screening visit [Visit 1] and any time
between screening visit [Visit 1] and baseline randomization [Visit 2]); or
have a score of 3 on Item 12 (Thoughts of Death or Suicide) of the Quick
Inventory of Depressive Symptomatology-Self-Report, 16 Items (QIDSSR16) at screening or baseline or are clinically judged by the investigator to
be at risk for suicide
[31] have donated more than a single unit of blood within 4 weeks prior to
screening or intend to donate blood during the course of the study
The Estimated Number of Participants
-
Taiwan
45 participants
-
Global
540 participants
