Clinical Trials List
Protocol NumberI4V-MC-JAIY
NCT Number(ClinicalTrials.gov Identfier)NCT03733301
2018-11-01 - 2019-12-31
Phase III
Terminated5
ICD-10L20
Atopic dermatitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Combination With Topical Corticosteroids in Adult Patients With Moderate to Severe Atopic Dermatitis BREEZE-AD7
-
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
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chia-Lun Chou Division of Dermatology
The Actual Total Number of Participants Enrolled
5 Stop recruiting
Audit
CRO
Principal Investigator
Linkou Chang Gung Medical Foundation
Taiwan National PI
Yu-Huei Huang
Co-Principal Investigator
- Yu-Huei Huang Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- Wen-Hung Chung Division of Dermatology
- Ng Chau Yee Division of Dermatology
- I-Hsin Shih Division of Dermatology
- 林怡廷 Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- Ya-Ching Chang Division of Dermatology
The Actual Total Number of Participants Enrolled
6 Stop recruiting
Audit
None
Co-Principal Investigator
- 卓雍哲 Division of Rheumatology
- Chih-Chieh Chan Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Moderate to Severe Atopic Dermatitis
Objectives
Primary Objective
To test the hypothesis that baricitinib 4-mg QD + TCS or baricitinib 2-mg QD + TCS is superior to placebo + TCS in the treatment of patients with moderate to severe AD.
Test Drug
Baricitinib (LY3009104)
Active Ingredient
Baricitinib (LY3009104)
Dosage Form
Dosage
2 mg/4 mg
Endpoints
Primary Outcome Measures :
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement [ Time Frame: Week 16 ]
The IGA measures investigators global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement [ Time Frame: Week 16 ]
The IGA measures investigators global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Inclution Criteria
Inclusion Criteria
Informed Consent
[1] are at least 18 years of age at the time of informed consent.
Note: Use local requirements to provide consent if the age of adulthood is
defined as >18 years
[2] are able to read, understand, and give documented (electronic or paper
signature) informed consent.
Type of Patient and Disease Characteristics
[3] have a diagnosis of AD at least 12 months prior to screening, as defined by the
American Academy of Dermatology: Guidelines of care for the management
of AD; Section 1. Diagnosis and assessment of atopic dermatitis (Appendix
7).
[4] have moderate to severe AD, including all of the following:
a. Eczema Area and Severity Index (EASI) score ≥16 at screening (Visit 1)
and at randomization (Visit 2)
b. IGA score of ≥3 at screening (Visit 1) and at randomization (Visit 2)
c. ≥10% of BSA involvement at screening (Visit 1) and at randomization
(Visit 2).
[5] have a documented history by a physician and/or investigator of inadequate
response to existing topical medications within 6 months preceding screening
as defined by at least 1 of the following:
a. inability to achieve good disease control defined as mild disease or better
(e.g., IGA ≤2) after use of at least a moderate potency TCS for at least
4 weeks, or for the maximum duration recommended by the product
prescribing information (e.g., 14 days for super-potent TCS), whichever
is shorter. Topical corticosteroids may be used with or without TCNIs.
b. Patients who failed systemic therapies intended to treat AD within
6 months preceding screening, such as cyclosporine, methotrexate,
azathioprine, and mycophenolate mofetil will also be considered as a
surrogate for having inadequate response to topical therapy.
[6] agree to discontinue use of the following excluded medications/treatments for
at least 4 weeks prior to randomization (Visit 2) and throughout the study:
a. oral systemic corticosteroids and leukotriene inhibitors
b. systemic immunomodulators, including, but not limited to, cyclosporine,
methotrexate, mycophenolate mofetil, and azathioprine
c. any other systemic therapy used to treat AD or symptoms of AD
(approved or off-label use)
[7] agree to discontinue the use of following excluded medications for at least
2 weeks prior to randomization (Visit 2):
a. TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus)
b. Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole)
c. sedating antihistamines, including, but not limited to, alimemazine,
chlorphenamine, clemastine, cyproheptadine, diphenhydramine,
hydroxyzine, ketotifen, and promethazine
Note: Patients may use newer, less sedating antihistamines
(Section 7.7.1) for the treatment of allergic conditions other than AD.
Use of antihistamines for the treatment of itch is not allowed during the
study.
d. phototherapy, includes therapeutic phototherapy (psoralen plus ultraviolet
A, ultraviolet B), excimer laser as well as self-treatment with tanning
beds.
[8] have applied emollients daily for at least 14 days prior to randomization and
agree to use emollient daily throughout the treatment period.
[9] Patients who are receiving chronic treatments to improve sleep should be on a
stable dose for at least 2 weeks prior to screening as determined by the
investigator. Sedating antihistamines (see above) are not permitted.
Patient Characteristics
[10] Male or nonpregnant, nonbreastfeeding female patients
Patients of child-bearing potential who are abstinent (if this is complete
abstinence, as their preferred and usual lifestyle) or in a same-sex relationship
(as part of their preferred and usual lifestyle) must agree to either remain
abstinent or stay in a same-sex relationship without sexual relationships with
the opposite sex.
Total abstinence is defined as refraining from intercourse during the entirety
of the study and for at least 1 week following the last dose of investigational
product. Periodic abstinence such as calendar, ovulation, symptothermal,
postovulation methods and withdrawal are not acceptable methods of
contraception.
Otherwise, patients and their partners of child-bearing potential must agree to
use 2 effective methods of contraception, where at least 1 form is highly
effective for the entirety of the study and for at least 1 week following the last
dose of investigational product.
The following contraception methods are considered acceptable (the patient,
and their partner, should choose 2, and 1 must be highly effective [defined as
<1% failure rate per year when used consistently and correctly]):
Highly effective birth control methods:
o Combined (estrogen- and progestogen-containing) hormonal
contraception associated with inhibition of ovulation: oral,
intravaginal, or transdermal
o Progestogen-only hormonal contraception associated with inhibition of
ovulation: oral, intravaginal, or implantable
o Intrauterine device/intrauterine hormone-releasing system
o Vasectomized partner (with appropriate post-vasectomy
documentation of the absence of sperm in the ejaculate).
Effective birth control methods:
o Male or female condom with spermicide. It should be noted that the
use of male and female condoms as a double barrier method is not
considered acceptable due to the high failure rate when these methods
are combined.
o Diaphragm with spermicide
o Cervical sponge
o Cervical cap with spermicide
o Oral contraceptives that do not inhibit ovulation
Note: When local guidelines concerning highly effective or effective
methods of birth control differ from the above, the local guidelines must
be followed.
a. Females of non–child-bearing potential are not required to use birth
control and they are defined as:
women ≥60 years of age or women who are congenitally sterile, or
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 women who are
surgically sterile (i.e., have had a hysterectomy or bilateral oophorectomy or
tubal ligation).
Informed Consent
[1] are at least 18 years of age at the time of informed consent.
Note: Use local requirements to provide consent if the age of adulthood is
defined as >18 years
[2] are able to read, understand, and give documented (electronic or paper
signature) informed consent.
Type of Patient and Disease Characteristics
[3] have a diagnosis of AD at least 12 months prior to screening, as defined by the
American Academy of Dermatology: Guidelines of care for the management
of AD; Section 1. Diagnosis and assessment of atopic dermatitis (Appendix
7).
[4] have moderate to severe AD, including all of the following:
a. Eczema Area and Severity Index (EASI) score ≥16 at screening (Visit 1)
and at randomization (Visit 2)
b. IGA score of ≥3 at screening (Visit 1) and at randomization (Visit 2)
c. ≥10% of BSA involvement at screening (Visit 1) and at randomization
(Visit 2).
[5] have a documented history by a physician and/or investigator of inadequate
response to existing topical medications within 6 months preceding screening
as defined by at least 1 of the following:
a. inability to achieve good disease control defined as mild disease or better
(e.g., IGA ≤2) after use of at least a moderate potency TCS for at least
4 weeks, or for the maximum duration recommended by the product
prescribing information (e.g., 14 days for super-potent TCS), whichever
is shorter. Topical corticosteroids may be used with or without TCNIs.
b. Patients who failed systemic therapies intended to treat AD within
6 months preceding screening, such as cyclosporine, methotrexate,
azathioprine, and mycophenolate mofetil will also be considered as a
surrogate for having inadequate response to topical therapy.
[6] agree to discontinue use of the following excluded medications/treatments for
at least 4 weeks prior to randomization (Visit 2) and throughout the study:
a. oral systemic corticosteroids and leukotriene inhibitors
b. systemic immunomodulators, including, but not limited to, cyclosporine,
methotrexate, mycophenolate mofetil, and azathioprine
c. any other systemic therapy used to treat AD or symptoms of AD
(approved or off-label use)
[7] agree to discontinue the use of following excluded medications for at least
2 weeks prior to randomization (Visit 2):
a. TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus)
b. Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole)
c. sedating antihistamines, including, but not limited to, alimemazine,
chlorphenamine, clemastine, cyproheptadine, diphenhydramine,
hydroxyzine, ketotifen, and promethazine
Note: Patients may use newer, less sedating antihistamines
(Section 7.7.1) for the treatment of allergic conditions other than AD.
Use of antihistamines for the treatment of itch is not allowed during the
study.
d. phototherapy, includes therapeutic phototherapy (psoralen plus ultraviolet
A, ultraviolet B), excimer laser as well as self-treatment with tanning
beds.
[8] have applied emollients daily for at least 14 days prior to randomization and
agree to use emollient daily throughout the treatment period.
[9] Patients who are receiving chronic treatments to improve sleep should be on a
stable dose for at least 2 weeks prior to screening as determined by the
investigator. Sedating antihistamines (see above) are not permitted.
Patient Characteristics
[10] Male or nonpregnant, nonbreastfeeding female patients
Patients of child-bearing potential who are abstinent (if this is complete
abstinence, as their preferred and usual lifestyle) or in a same-sex relationship
(as part of their preferred and usual lifestyle) must agree to either remain
abstinent or stay in a same-sex relationship without sexual relationships with
the opposite sex.
Total abstinence is defined as refraining from intercourse during the entirety
of the study and for at least 1 week following the last dose of investigational
product. Periodic abstinence such as calendar, ovulation, symptothermal,
postovulation methods and withdrawal are not acceptable methods of
contraception.
Otherwise, patients and their partners of child-bearing potential must agree to
use 2 effective methods of contraception, where at least 1 form is highly
effective for the entirety of the study and for at least 1 week following the last
dose of investigational product.
The following contraception methods are considered acceptable (the patient,
and their partner, should choose 2, and 1 must be highly effective [defined as
<1% failure rate per year when used consistently and correctly]):
Highly effective birth control methods:
o Combined (estrogen- and progestogen-containing) hormonal
contraception associated with inhibition of ovulation: oral,
intravaginal, or transdermal
o Progestogen-only hormonal contraception associated with inhibition of
ovulation: oral, intravaginal, or implantable
o Intrauterine device/intrauterine hormone-releasing system
o Vasectomized partner (with appropriate post-vasectomy
documentation of the absence of sperm in the ejaculate).
Effective birth control methods:
o Male or female condom with spermicide. It should be noted that the
use of male and female condoms as a double barrier method is not
considered acceptable due to the high failure rate when these methods
are combined.
o Diaphragm with spermicide
o Cervical sponge
o Cervical cap with spermicide
o Oral contraceptives that do not inhibit ovulation
Note: When local guidelines concerning highly effective or effective
methods of birth control differ from the above, the local guidelines must
be followed.
a. Females of non–child-bearing potential are not required to use birth
control and they are defined as:
women ≥60 years of age or women who are congenitally sterile, or
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 women who are
surgically sterile (i.e., have had a hysterectomy or bilateral oophorectomy or
tubal ligation).
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from study enrollment if they meet any of the following criteria:
Medical Conditions Related to Atopic Dermatitis
[11] are currently experiencing or have a history of other concomitant skin
conditions (e.g., psoriasis or lupus erythematosus) that would interfere with
evaluations of the effect of study medication on AD.
[12] have had an important side effect to TCS (e.g., intolerance to treatment,
hypersensitivity reactions, significant skin atrophy, and systemic effects), as
assessed by the investigator or treating physician that would prevent further
use.
[13] patients who, in the opinion of the investigator, are currently experiencing or
have a history of erythrodermic, refractory, or unstable skin disease that
requires frequent hospitalizations and/or intravenous treatment for skin
infections that may interfere with participation in the study.
[14] a history of eczema herpeticum within 12 months prior to screening.
[15] a history of 2 or more episodes of eczema herpeticum in the past.
[16] patients who are currently experiencing a skin infection that requires
treatment, or is currently being treated, with topical or systemic antibiotics.
Note: Patients may not be rescreened until at least 4 weeks after the date of
their previous screen failure and at least 2 weeks after resolution of the
infection.
[17] have any serious concomitant illness that is anticipated to require the use of
systemic corticosteroids or otherwise interfere with study participation or
require active frequent monitoring (e.g., unstable chronic asthma).
[18] have been treated with the following therapies:
a. monoclonal antibody (e.g., ustekinumab, omalizumab, and dupilumab) or
fusion proteins that target inflammatory pathways (e.g., etanercept) for
less than 5 half-lives prior to randomization.
b. received prior treatment with any oral JAK inhibitor (e.g., tofacitinib and
ruxolitinib) <4 weeks prior to randomization
c. received any parenteral corticosteroid administered by intramuscular or
intravenous injection within 6 weeks prior to planned randomization
(Visit 2) or are anticipated to require parenteral injection of
corticosteroids during the study.
d. have had an intra-articular corticosteroid injection within 6 weeks prior to
planned randomization (Visit 2).
Note: Intranasal or inhaled steroid use is allowed during the trial.
e. probenecid at the time of randomization (Visit 2) that cannot be
discontinued for the duration of the study
Medical Conditions in General
[19] are largely or wholly incapacitated permitting little or no self-care, such as
being bed-ridden.
[20] have uncontrolled arterial hypertension characterized by a repeated systolic
blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg in a
seated position. Reassessment of blood pressure during the screening period
is allowed.
[21] 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 if participating in the trial.
[22] are immunocompromised and, in the opinion of the investigator, at an
unacceptable risk for participating in the study.
[23] have experienced any of the following within 12 weeks of screening: VTE,
myocardial infarction (MI), unstable ischemic heart disease, stroke, or New
York Heart Association Stage III/IV heart failure.
[24] have a history of recurrent (≥2) VTE or are considered at high risk of VTE as
deemed by the investigator.
[25] have a history or presence of cardiovascular, respiratory, 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.
[26] have a history of lymphoproliferative disease; or have signs or symptoms
suggestive of possible lymphoproliferative disease, including
lymphadenopathy or splenomegaly; or have active primary or recurrent
malignant disease; or have been in remission from clinically significant
malignancy for less than 5 years.
a. Patients with cervical carcinoma in situ that has been appropriately
treated 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
appropriately treated with no evidence of recurrence for at least 3 years
may participate in the study.
[27] have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection, including but not limited to the following:
Note: A recent viral upper respiratory tract infection or uncomplicated
urinary tract infection should not be considered clinically serious.
a. symptomatic herpes zoster infection within 12 weeks prior to screening.
b. a history of disseminated/complicated herpes zoster (e.g.,
multidermatomal involvement, ophthalmic zoster, central nervous system
involvement, or postherpetic 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 planned
randomization or are expected to need/receive a live vaccine during the course
of the study (with the exception of herpes zoster vaccination).
Note: Patients eligible for herpes zoster vaccine, who have not received it
prior to screening will be encouraged (per local guidelines) to do so prior to
randomization; vaccination with the live herpes zoster vaccine can occur
during the screening period but must take place >4 weeks prior to
randomization and start of IP.
Vaccination with the non-live herpes zoster vaccine requires at least
2 injections administered 8 weeks apart and, therefore, cannot be completed
during the 5 week screening period. Patients who have initiated vaccination
with non-live herpes zoster vaccine before the trial should plan to receive the
second dose at least 4 weeks prior to randomization.
[29] have a history of chronic alcohol abuse, intravenous drug abuse, or other illicit
drug abuse within the 2 years prior to screening.
[30] presence of significant uncontrolled neuropsychiatric disorder, are clinically
judged by the investigator to be at risk for suicide, or have a “yes” answer to
any of the following:
a. question 4 (Active Suicidal Ideation with Some Intent to Act, Without
Specific Plan) on the “Suicidal Ideation” portion of the Columbia Suicide
Severity Rating Scale (C-SSRS) or b. question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the
“Suicidal Ideation” portion of the C-SSRS or
c. any of the suicide-related behaviors (actual attempt, interrupted attempt,
aborted attempt, and preparatory act or behavior) on the “Suicidal
Behavior” portion of the C-SSRS;
and the ideation or behavior occurred within 2 months prior to Visit 1.
Note: a patient does not necessarily have to be excluded if they have
self-injurious behavior that would be classified as nonsuicidal self-injurious
behavior. If this situation arises, the subject should be referred to a
psychiatrist or appropriately trained professional as indicated.
[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:
Medical Conditions Related to Atopic Dermatitis
[11] are currently experiencing or have a history of other concomitant skin
conditions (e.g., psoriasis or lupus erythematosus) that would interfere with
evaluations of the effect of study medication on AD.
[12] have had an important side effect to TCS (e.g., intolerance to treatment,
hypersensitivity reactions, significant skin atrophy, and systemic effects), as
assessed by the investigator or treating physician that would prevent further
use.
[13] patients who, in the opinion of the investigator, are currently experiencing or
have a history of erythrodermic, refractory, or unstable skin disease that
requires frequent hospitalizations and/or intravenous treatment for skin
infections that may interfere with participation in the study.
[14] a history of eczema herpeticum within 12 months prior to screening.
[15] a history of 2 or more episodes of eczema herpeticum in the past.
[16] patients who are currently experiencing a skin infection that requires
treatment, or is currently being treated, with topical or systemic antibiotics.
Note: Patients may not be rescreened until at least 4 weeks after the date of
their previous screen failure and at least 2 weeks after resolution of the
infection.
[17] have any serious concomitant illness that is anticipated to require the use of
systemic corticosteroids or otherwise interfere with study participation or
require active frequent monitoring (e.g., unstable chronic asthma).
[18] have been treated with the following therapies:
a. monoclonal antibody (e.g., ustekinumab, omalizumab, and dupilumab) or
fusion proteins that target inflammatory pathways (e.g., etanercept) for
less than 5 half-lives prior to randomization.
b. received prior treatment with any oral JAK inhibitor (e.g., tofacitinib and
ruxolitinib) <4 weeks prior to randomization
c. received any parenteral corticosteroid administered by intramuscular or
intravenous injection within 6 weeks prior to planned randomization
(Visit 2) or are anticipated to require parenteral injection of
corticosteroids during the study.
d. have had an intra-articular corticosteroid injection within 6 weeks prior to
planned randomization (Visit 2).
Note: Intranasal or inhaled steroid use is allowed during the trial.
e. probenecid at the time of randomization (Visit 2) that cannot be
discontinued for the duration of the study
Medical Conditions in General
[19] are largely or wholly incapacitated permitting little or no self-care, such as
being bed-ridden.
[20] have uncontrolled arterial hypertension characterized by a repeated systolic
blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg in a
seated position. Reassessment of blood pressure during the screening period
is allowed.
[21] 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 if participating in the trial.
[22] are immunocompromised and, in the opinion of the investigator, at an
unacceptable risk for participating in the study.
[23] have experienced any of the following within 12 weeks of screening: VTE,
myocardial infarction (MI), unstable ischemic heart disease, stroke, or New
York Heart Association Stage III/IV heart failure.
[24] have a history of recurrent (≥2) VTE or are considered at high risk of VTE as
deemed by the investigator.
[25] have a history or presence of cardiovascular, respiratory, 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.
[26] have a history of lymphoproliferative disease; or have signs or symptoms
suggestive of possible lymphoproliferative disease, including
lymphadenopathy or splenomegaly; or have active primary or recurrent
malignant disease; or have been in remission from clinically significant
malignancy for less than 5 years.
a. Patients with cervical carcinoma in situ that has been appropriately
treated 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
appropriately treated with no evidence of recurrence for at least 3 years
may participate in the study.
[27] have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection, including but not limited to the following:
Note: A recent viral upper respiratory tract infection or uncomplicated
urinary tract infection should not be considered clinically serious.
a. symptomatic herpes zoster infection within 12 weeks prior to screening.
b. a history of disseminated/complicated herpes zoster (e.g.,
multidermatomal involvement, ophthalmic zoster, central nervous system
involvement, or postherpetic 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 planned
randomization or are expected to need/receive a live vaccine during the course
of the study (with the exception of herpes zoster vaccination).
Note: Patients eligible for herpes zoster vaccine, who have not received it
prior to screening will be encouraged (per local guidelines) to do so prior to
randomization; vaccination with the live herpes zoster vaccine can occur
during the screening period but must take place >4 weeks prior to
randomization and start of IP.
Vaccination with the non-live herpes zoster vaccine requires at least
2 injections administered 8 weeks apart and, therefore, cannot be completed
during the 5 week screening period. Patients who have initiated vaccination
with non-live herpes zoster vaccine before the trial should plan to receive the
second dose at least 4 weeks prior to randomization.
[29] have a history of chronic alcohol abuse, intravenous drug abuse, or other illicit
drug abuse within the 2 years prior to screening.
[30] presence of significant uncontrolled neuropsychiatric disorder, are clinically
judged by the investigator to be at risk for suicide, or have a “yes” answer to
any of the following:
a. question 4 (Active Suicidal Ideation with Some Intent to Act, Without
Specific Plan) on the “Suicidal Ideation” portion of the Columbia Suicide
Severity Rating Scale (C-SSRS) or b. question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the
“Suicidal Ideation” portion of the C-SSRS or
c. any of the suicide-related behaviors (actual attempt, interrupted attempt,
aborted attempt, and preparatory act or behavior) on the “Suicidal
Behavior” portion of the C-SSRS;
and the ideation or behavior occurred within 2 months prior to Visit 1.
Note: a patient does not necessarily have to be excluded if they have
self-injurious behavior that would be classified as nonsuicidal self-injurious
behavior. If this situation arises, the subject should be referred to a
psychiatrist or appropriately trained professional as indicated.
[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
60 participants
-
Global
300 participants
