Clinical Trials List
Protocol NumberI4V-MC-JAIP
NCT Number(ClinicalTrials.gov Identfier)NCT03952559
Active
2019-04-15 - 2027-12-31
Phase III
Recruiting7
ICD-10L22
Diaper dermatitis
ICD-9691.0
Diaper or napkin rash
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chia-Lun Chou Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Bing Chen Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- 紀敏慧 Division of Dermatology
- Yu-Huei Huang Division of Dermatology
- Chun-Wei Lu Division of Dermatology
- 傅真如 Division of Radiology
- I-Hsin Shih Division of Pediatrics
- Wen-Hung Chung Division of Dermatology
- 陳建銘 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林尚宏 Division of Dermatology
- 鄭裕文 Division of Dermatology
- Tzung-Jeng Hwang
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Yuan Li Division of Dermatology
- Yun-Ting Chang Division of Dermatology
- 何翊芯 Division of Dermatology
- DINGDAR LEE Division of Dermatology
- 吳貞宜 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
- 陳世杰 Division of Radiology
- 卓雍哲 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Atopic Dermatitis
Objectives
Primary Objective for Double-blind Treatment
Period
To demonstrate the superiority of each dose of
baricitinib versus placebo in the treatment of
patients with moderate-to-severe AD.
Primary Objective for PK lead-in Period
To assess whether baricitinib exposure in
pediatric patients receiving baricitinib high
dose once daily is comparable to the exposure
in adults receiving baricitinib 4-mg once daily.
Key Secondary Objectives
These are prespecified objectives that will be adjusted
for multiplicity
To compare the efficacy of baricitinib high,
medium, or low dose to placebo in AD during
the 16-week double-blind placebo-controlled
treatment period as measured by improvement
in signs and symptoms of AD.
To compare the efficacy of baricitinib high,
medium, or low dose to placebo in AD during
the 16-week double-blind placebo-controlled
treatment period as assessed by patient-reported
outcome measures.
Test Drug
Olumiant
Active Ingredient
Baricitinib (LY3009104)
Dosage Form
tablet/suspension
Dosage
1mg、2mg、 4mg、2 mg/ml
Endpoints
Proportion of patients achieving IGA of 0 or 1
with a ≥2-point improvement at Week 16
Comparability will be assessed using noncompartmental methods (e.g., AUC and Cmax)
with a ≥2-point improvement at Week 16
Comparability will be assessed using noncompartmental methods (e.g., AUC and Cmax)
Inclution Criteria
[1] Are 2 to <18 years of age and are at or above the 5th percentile of weight for
age (e.g., ≥10.6 kg for a 2 year old) at the time of informed consent. Full date
of birth will be recorded except in countries where it is not allowed.
[2] have a diagnosis of AD at least 12 months (if ≥6 years old) and at least
6 months (if 2 to <6 years old) 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 8).
[3] have moderate-to-severe AD, including all of the following:
a. EASI score ≥16 at screening (Visit 1) and at Visit 2
b. IGA score of ≥3 at screening (Visit 1) and at Visit 2
c. ≥10% of BSA involvement at screening (Visit 1) and at Visit 2.
[4] Have a documented history by a physician and/or investigator of inadequate response
to OR history of intolerance to topical corticosteroids (TCS) AND topical calcineurin
inhibitors (TCNI).
Inadequate response is defined as failure to achieve stable long-term disease control
(for example, IGA ≤2) based on the following criteria:
TCS: 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, within 6 months of
screening.
TCNI: after use for at least 4 weeks of treatment or for the maximum duration
recommended by the product prescribing information, whichever is shorter.
TCS and TCNI: Patients who failed systemic therapies intended to
treat AD within 6 months preceding screening, such as cyclosporine,
methotrexate, azathioprine, systemic corticosteroids, or mycophenolate
mofetil will also be considered as a surrogate for having inadequate
response to topical therapy.
Intolerance to a topical therapy (TCS or TCNI) is defined as:
a documented history of clinically significant adverse reactions that in
the opinion of the investigator outweigh the benefits of retreatment
(e.g., skin atrophy, allergic reactions, or systemic effects for TCS and
skin burning for TCNI).
[5] agree to discontinue use of the following excluded medications/treatments for
at least 4 weeks prior to Visit 2 and throughout the study unless otherwise
specified below:
a. oral systemic corticosteroids
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)
d. phototherapy, includes therapeutic phototherapy (psoralen plus
ultraviolet-A, ultraviolet-B), excimer laser as well as self-treatment with
tanning beds (see Section 7.7.5 regarding use as recue therapy).
[6] agree to discontinue use of the following excluded medications for at least
7 days prior to Visit 2 and throughout the study unless otherwise specified
(see Section 7.7):
a. TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus)
b. Topical PDE-4 inhibitor (crisaborole)
c. Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other
investigative topical treatments.
[7] have applied emollients daily for at least 14 days prior to Visit 2 and agree to
use emollient daily throughout the study.
[8] are male or nonpregnant, nonbreastfeeding female patients
[9] A parent or legal guardian must be able to read, understand, and give
documented (electronic or paper signature) informed consent for a child to
participate in this study. In addition to informed consent given by the parent
or legal guardian, the pediatric patient, if capable, may be required to give
documented assent as specified by ethics board(s).
age (e.g., ≥10.6 kg for a 2 year old) at the time of informed consent. Full date
of birth will be recorded except in countries where it is not allowed.
[2] have a diagnosis of AD at least 12 months (if ≥6 years old) and at least
6 months (if 2 to <6 years old) 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 8).
[3] have moderate-to-severe AD, including all of the following:
a. EASI score ≥16 at screening (Visit 1) and at Visit 2
b. IGA score of ≥3 at screening (Visit 1) and at Visit 2
c. ≥10% of BSA involvement at screening (Visit 1) and at Visit 2.
[4] Have a documented history by a physician and/or investigator of inadequate response
to OR history of intolerance to topical corticosteroids (TCS) AND topical calcineurin
inhibitors (TCNI).
Inadequate response is defined as failure to achieve stable long-term disease control
(for example, IGA ≤2) based on the following criteria:
TCS: 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, within 6 months of
screening.
TCNI: after use for at least 4 weeks of treatment or for the maximum duration
recommended by the product prescribing information, whichever is shorter.
TCS and TCNI: Patients who failed systemic therapies intended to
treat AD within 6 months preceding screening, such as cyclosporine,
methotrexate, azathioprine, systemic corticosteroids, or mycophenolate
mofetil will also be considered as a surrogate for having inadequate
response to topical therapy.
Intolerance to a topical therapy (TCS or TCNI) is defined as:
a documented history of clinically significant adverse reactions that in
the opinion of the investigator outweigh the benefits of retreatment
(e.g., skin atrophy, allergic reactions, or systemic effects for TCS and
skin burning for TCNI).
[5] agree to discontinue use of the following excluded medications/treatments for
at least 4 weeks prior to Visit 2 and throughout the study unless otherwise
specified below:
a. oral systemic corticosteroids
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)
d. phototherapy, includes therapeutic phototherapy (psoralen plus
ultraviolet-A, ultraviolet-B), excimer laser as well as self-treatment with
tanning beds (see Section 7.7.5 regarding use as recue therapy).
[6] agree to discontinue use of the following excluded medications for at least
7 days prior to Visit 2 and throughout the study unless otherwise specified
(see Section 7.7):
a. TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus)
b. Topical PDE-4 inhibitor (crisaborole)
c. Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other
investigative topical treatments.
[7] have applied emollients daily for at least 14 days prior to Visit 2 and agree to
use emollient daily throughout the study.
[8] are male or nonpregnant, nonbreastfeeding female patients
[9] A parent or legal guardian must be able to read, understand, and give
documented (electronic or paper signature) informed consent for a child to
participate in this study. In addition to informed consent given by the parent
or legal guardian, the pediatric patient, if capable, may be required to give
documented assent as specified by ethics board(s).
Exclusion Criteria
[10] 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.
[11] are 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 (IV) treatment for skin
infections that may interfere with participation in the study.
[12] have a history of eczema herpeticum within 12 months prior to screening.
[13] have a history of 2 or more episodes of eczema herpeticum in the past.
[14] are 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.
[15] 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).
[16] have been treated with the following therapies:
a. monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for
less than 5 half-lives prior to Visit 2.
b. prior treatment with any oral JAK inhibitor (e.g., tofacitinib, ruxolitinib)
less than 4 weeks prior to Visit 2
c. any parenteral corticosteroid administered by intramuscular or IV
injection within 2 weeks prior to study entry (Visit 1) or within 6 weeks
prior to planned randomization (Visit 2) or are anticipated to require
parenteral injection of corticosteroids during the study.
d. an intra-articular corticosteroid injection within 2 weeks prior to study
entry (Visit 1) or 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 Visit 2 that cannot be discontinued for the
duration of the study
[17] are largely or wholly incapacitated permitting little or no self-care, such as
being bedridden.
[18] have uncontrolled arterial hypertension as determined by the investigator and
characterized by a repeated systolic or diastolic blood pressure >95th
percentile based on age, sex and height.
[19] 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.
[20] are immunocompromised and, in the opinion of the investigator, at an
unacceptable risk for participating in the study.
[21] 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.
[22] have a history of VTE or are considered at high risk of VTE as deemed by the
investigator.
[23] 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 IP or interfere
with the interpretation of data.
[24] 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.
[25] 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. typhoid infection within 12 weeks prior to screening.
b. a history of herpes zoster (shingles).
c. symptomatic herpes simplex at Visit 2.
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).
f. history of TB or evidence of active TB
g. clinically serious infection or received IV antibiotics for an infection,
within the past 4 weeks of Visit 2.
h. any other active or recent infection within 4 weeks of Visit 2 (including
chicken pox) that, in the opinion of the investigator, would pose an
unacceptable risk to the patient if participating in the study.
[26] have received a typhoid or BCG live vaccine within 12 weeks of Visit 2 or
have received any other live vaccine within 28 days prior to Visit 2 or intend
to receive a live vaccine during Study Period 2 or 3.
[27] have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug
abuse within the 2 years prior to screening.
[28] have 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 on the Columbia Suicide Severity Rating Scale
(C-SSRS) collected for patients ≥7 years old at the screening visit:
a. Question 4 (Active Suicidal Ideation with Some Intent to Act, Without
Specific Plan) on the “Suicidal Ideation” portion of the 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, 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 patient should be referred to a
psychiatrist or appropriately trained professional as indicated.
[29] 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.
[30] are currently enrolled in any other clinical study involving an IP or any other
type of medical research judged not to be scientifically or medically
compatible with this study.
[31] have participated, within the last 30 days (3 months for studies conducted in
the UK) in a clinical study involving an IP.
If the previous IP has a long half-life (2 weeks or longer), 5 half-lives or 30
days (whichever is longer) should have passed (3 months for studies
conducted in the UK).
[32] have previously been randomized in this study or any other study
investigating baricitinib, or who have experienced hypersensitivity to the
active substance or to any of the excipients.
[33] patient or parent/caregiver/legal guardian are unable or unwilling to make
themselves available for the duration of the study and/or are unwilling to
follow study restrictions/procedures, including use of data collection devices.
[34] are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
[35] are Lilly or Incyte employees or their designee.
[36] have screening electrocardiogram (ECG) abnormalities that, in the opinion of
the investigator, are clinically significant and indicate an unacceptable risk for
the patient’s participation in the study.
[37] Patients with evidence of active TB or latent TB based on medical history and
clinical features are excluded. In addition, if the following criteria are met,
the patient will be excluded:
o positive PPD test (i.e., ≥5 mm induration between approximately 48
and 72 hours after application, regardless of vaccination history),
and/or
o QuantiFERON®-TB Gold test or T-SPOT® TB test (as available and if
compliant with local TB guidelines) may be used instead of the PPD
test. If the test results are positive, the patient will be excluded. If the
test is not negative, the test may be repeated once within
approximately 2 weeks of the initial value. If the repeat test results are
again not negative, the patient will be excluded.
[38] have a positive test for HBV infection defined as:
a. positive for hepatitis B surface antigen (HBsAg), or
b. positive for hepatitis B core antibody (HBcAb) and positive hepatitis B
virus deoxyribonucleic acid (HBV DNA).
Note: Patients who are HBcAb positive and HBV DNA negative may be
enrolled in the study. Patients who meet these criteria at screening will be
identified by the central laboratory and monitored during the study.
[39] have HCV infection (positive for anti-hepatitis C antibody with confirmed
presence of HCV ribonucleic acid [RNA])
Note: Patients who have documented anti-HCV treatment for a past HCV
infection AND are HCV RNA negative may be enrolled in the study.
[40] have evidence of HIV infection and/or positive HIV antibodies.
[41] have screening laboratory test values, including thyroid-stimulating hormone
(TSH), outside the reference range for the population or investigative site that,
in the opinion of the investigator, pose an unacceptable risk for the patient’s
participation in the study.
Note: Patients who are receiving thyroxine as replacement therapy may
participate in the study, provided stable therapy has been administered for
≥12 weeks and TSH is within the laboratory’s reference range. Patients who
are receiving stable thyroxine replacement therapy who have TSH marginally
outside the laboratory’s normal reference range may participate if the treating
physician has documented that the thyroxine replacement therapy is adequate
for the patient.
[42] have any of the following specific abnormalities on screening laboratory tests:
a. AST or ALT ≥2x upper limit of normal (ULN)
b. alkaline phosphatase (ALP) ≥2x ULN
Note: Patients may be allowed to enroll if there is no other evidence of
liver, bone, or other abnormality but cases must be discussed and judged
not clinically significant by Lilly Medical prior to enrollment.
c. total bilirubin ≥1.5x ULN
Note: Patients may be allowed to enroll if there is no other evidence of
liver or other abnormality but cases must be discussed and judged not
clinically significant by Lilly Medical prior to enrollment.
d. hemoglobin <10.0 g/dL (100.0 g/L)
e. total white blood cell count <2500 cells/µL (<2.50x103/µL or
<2.50 GI/L)
f. neutropenia (absolute neutrophil count [ANC] <1200 cells/µL)
(<1.20x103/µL or <1.20 GI/L)
g. lymphopenia (lymphocyte count <750 cells/µL) (<0.75x103/µL or
<0.75 GI/L)
h. thrombocytopenia (platelets <100,000/µL) (<100x103/µL or <100 GI/L)
i. estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (eGFR,
calculated using Bedside Schwartz 2009 formula).
conditions (e.g., psoriasis or lupus erythematosus) that would interfere with
evaluations of the effect of study medication on AD.
[11] are 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 (IV) treatment for skin
infections that may interfere with participation in the study.
[12] have a history of eczema herpeticum within 12 months prior to screening.
[13] have a history of 2 or more episodes of eczema herpeticum in the past.
[14] are 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.
[15] 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).
[16] have been treated with the following therapies:
a. monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for
less than 5 half-lives prior to Visit 2.
b. prior treatment with any oral JAK inhibitor (e.g., tofacitinib, ruxolitinib)
less than 4 weeks prior to Visit 2
c. any parenteral corticosteroid administered by intramuscular or IV
injection within 2 weeks prior to study entry (Visit 1) or within 6 weeks
prior to planned randomization (Visit 2) or are anticipated to require
parenteral injection of corticosteroids during the study.
d. an intra-articular corticosteroid injection within 2 weeks prior to study
entry (Visit 1) or 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 Visit 2 that cannot be discontinued for the
duration of the study
[17] are largely or wholly incapacitated permitting little or no self-care, such as
being bedridden.
[18] have uncontrolled arterial hypertension as determined by the investigator and
characterized by a repeated systolic or diastolic blood pressure >95th
percentile based on age, sex and height.
[19] 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.
[20] are immunocompromised and, in the opinion of the investigator, at an
unacceptable risk for participating in the study.
[21] 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.
[22] have a history of VTE or are considered at high risk of VTE as deemed by the
investigator.
[23] 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 IP or interfere
with the interpretation of data.
[24] 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.
[25] 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. typhoid infection within 12 weeks prior to screening.
b. a history of herpes zoster (shingles).
c. symptomatic herpes simplex at Visit 2.
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).
f. history of TB or evidence of active TB
g. clinically serious infection or received IV antibiotics for an infection,
within the past 4 weeks of Visit 2.
h. any other active or recent infection within 4 weeks of Visit 2 (including
chicken pox) that, in the opinion of the investigator, would pose an
unacceptable risk to the patient if participating in the study.
[26] have received a typhoid or BCG live vaccine within 12 weeks of Visit 2 or
have received any other live vaccine within 28 days prior to Visit 2 or intend
to receive a live vaccine during Study Period 2 or 3.
[27] have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug
abuse within the 2 years prior to screening.
[28] have 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 on the Columbia Suicide Severity Rating Scale
(C-SSRS) collected for patients ≥7 years old at the screening visit:
a. Question 4 (Active Suicidal Ideation with Some Intent to Act, Without
Specific Plan) on the “Suicidal Ideation” portion of the 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, 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 patient should be referred to a
psychiatrist or appropriately trained professional as indicated.
[29] 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.
[30] are currently enrolled in any other clinical study involving an IP or any other
type of medical research judged not to be scientifically or medically
compatible with this study.
[31] have participated, within the last 30 days (3 months for studies conducted in
the UK) in a clinical study involving an IP.
If the previous IP has a long half-life (2 weeks or longer), 5 half-lives or 30
days (whichever is longer) should have passed (3 months for studies
conducted in the UK).
[32] have previously been randomized in this study or any other study
investigating baricitinib, or who have experienced hypersensitivity to the
active substance or to any of the excipients.
[33] patient or parent/caregiver/legal guardian are unable or unwilling to make
themselves available for the duration of the study and/or are unwilling to
follow study restrictions/procedures, including use of data collection devices.
[34] are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
[35] are Lilly or Incyte employees or their designee.
[36] have screening electrocardiogram (ECG) abnormalities that, in the opinion of
the investigator, are clinically significant and indicate an unacceptable risk for
the patient’s participation in the study.
[37] Patients with evidence of active TB or latent TB based on medical history and
clinical features are excluded. In addition, if the following criteria are met,
the patient will be excluded:
o positive PPD test (i.e., ≥5 mm induration between approximately 48
and 72 hours after application, regardless of vaccination history),
and/or
o QuantiFERON®-TB Gold test or T-SPOT® TB test (as available and if
compliant with local TB guidelines) may be used instead of the PPD
test. If the test results are positive, the patient will be excluded. If the
test is not negative, the test may be repeated once within
approximately 2 weeks of the initial value. If the repeat test results are
again not negative, the patient will be excluded.
[38] have a positive test for HBV infection defined as:
a. positive for hepatitis B surface antigen (HBsAg), or
b. positive for hepatitis B core antibody (HBcAb) and positive hepatitis B
virus deoxyribonucleic acid (HBV DNA).
Note: Patients who are HBcAb positive and HBV DNA negative may be
enrolled in the study. Patients who meet these criteria at screening will be
identified by the central laboratory and monitored during the study.
[39] have HCV infection (positive for anti-hepatitis C antibody with confirmed
presence of HCV ribonucleic acid [RNA])
Note: Patients who have documented anti-HCV treatment for a past HCV
infection AND are HCV RNA negative may be enrolled in the study.
[40] have evidence of HIV infection and/or positive HIV antibodies.
[41] have screening laboratory test values, including thyroid-stimulating hormone
(TSH), outside the reference range for the population or investigative site that,
in the opinion of the investigator, pose an unacceptable risk for the patient’s
participation in the study.
Note: Patients who are receiving thyroxine as replacement therapy may
participate in the study, provided stable therapy has been administered for
≥12 weeks and TSH is within the laboratory’s reference range. Patients who
are receiving stable thyroxine replacement therapy who have TSH marginally
outside the laboratory’s normal reference range may participate if the treating
physician has documented that the thyroxine replacement therapy is adequate
for the patient.
[42] have any of the following specific abnormalities on screening laboratory tests:
a. AST or ALT ≥2x upper limit of normal (ULN)
b. alkaline phosphatase (ALP) ≥2x ULN
Note: Patients may be allowed to enroll if there is no other evidence of
liver, bone, or other abnormality but cases must be discussed and judged
not clinically significant by Lilly Medical prior to enrollment.
c. total bilirubin ≥1.5x ULN
Note: Patients may be allowed to enroll if there is no other evidence of
liver or other abnormality but cases must be discussed and judged not
clinically significant by Lilly Medical prior to enrollment.
d. hemoglobin <10.0 g/dL (100.0 g/L)
e. total white blood cell count <2500 cells/µL (<2.50x103/µL or
<2.50 GI/L)
f. neutropenia (absolute neutrophil count [ANC] <1200 cells/µL)
(<1.20x103/µL or <1.20 GI/L)
g. lymphopenia (lymphocyte count <750 cells/µL) (<0.75x103/µL or
<0.75 GI/L)
h. thrombocytopenia (platelets <100,000/µL) (<100x103/µL or <100 GI/L)
i. estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (eGFR,
calculated using Bedside Schwartz 2009 formula).
The Estimated Number of Participants
-
Taiwan
64 participants
-
Global
465 participants
