| Eligibility |
Inclusion Criteria:
1. Voluntarily sign the informed consent form prior to starting any study-related
procedures, be able to communicate with the investigator, understand and be willing to
complete this study in strict accordance with the requirements of the study protocol;
2. Age = 18 years and = 65 years on the day of signing informed consent form, male or
female;
3. Have been diagnosed with atopic dermatitis (as per American Academy of Dermatology
Criteria[6], 2014) for at least 1 year prior to screening;
4. Have moderate to severe atopic dermatitis during screening and baseline periods.
Moderate to severe disease is defined as meeting the following 3 conditions at the
same time:
1) Eczema Area and Severity Index (EASI) score = 12; 2) Investigator's Global Assessment
(IGA) score = 3; 3) Body Surface Area Involvement of Atopic Dermatitis (BSA) = 10%; 5.
Subjects must meet at least one of the following conditions within 6 months prior to
screening, as judged by the investigator:
1. Inadequate response to stable treatment with topical corticosteroids (TCS) and/or
topical calcineurin inhibitors (TCI) for at least 4 weeks;
2. Or inadequate response to longest duration of treatment recommended by the prescribing
information of a topical medication (such as: 14 days of treatment with super potent
TCS);
3. Or unsuitable for topical treatment as judged by the investigator (such as intolerable
or with contraindications); 6. Have used stable doses of basic, mild, topical
emollient (moisturizer) without active ingredients twice daily for at least 7
consecutive days prior to baseline period, and continue to use during the study; 7.
Subjects (including their partners) must have no fertility plan and agree to adopt
effective contraceptive measures throughout the study (starting from 2 weeks before
the first dose for female subjects) until 4 months after the last dose. Male subjects
must agree to use a condom during intercourse throughout the study until 4 months
after the last dose; female subjects of childbearing potential must have a negative
human chorionic gonadotropin (HCG) test result during screening or baseline period,
not be breastfeeding, and only be enrolled after confirmation of the last
menstruation; female subjects without childbearing potential, the definition of
without childbearing potential is: permanent sterilization (such as bilateral
oophorectomy, hysterectomy, bilateral salpingectomy) or menopausal women (defined as
more than 12 months of amenorrhea without pathological etiology and serum
follicle-stimulating hormone (FSH) > 40 IU/L).
Exclusion Criteria:
-
General conditions:
1. Pregnant or lactating women (pregnancy is defined as the state from conception to
termination of gestation) or tested positive for human chorionic gonadotropin (HCG);
2. Have a history of alcohol abuse or illegal drug abuse within 6 months prior to
screening;
3. Have conditions that may affect the safety and efficacy evaluations of the
investigational product based on the investigator's judgment; 2. Laboratory test
results and/or 12-lead ECG findings during the screening or baseline period (tests may
be repeated one time for confirmation when necessary):
1) Hemoglobin < 100.0 g/L (male) or < 90.0 g/L (female); 2) White blood cell count < 3.0 ×
109/L; 3) Neutrophil count < 1.5 × 109/L; 4) Platelet count < 100 × 109/L; 5) Alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal
(ULN); 6) Total bilirubin (T-BIL) > 1.5 × ULN; 7) Serum creatinine > ULN; 8) Positive for
hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody (HIV), syphilis
antibody, or hepatitis C virus (HCV) antibody; 9) Clinically significant abnormal 12-lead
ECG findings that may affect the subject safety, including but not limited to acute
myocardial ischemia, myocardial infarction, severe arrhythmia, or significant QTc
prolongation (QTc > 500 ms).
3. Have any of the following medical histories or concurrent diseases:
1. Allergy to investigational product or any component of the investigational product;
2. History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC);
3. Known or suspected history of immunosuppression, including a history of invasive
opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis,
coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has
resolved; or abnormally frequent, recurrent, or long-term infection based on the
investigator's judgment;
4. active chronic active or acute infection requiring systemic treatments such as
antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks
prior to screening; or superficial skin infection within 1 week prior to screening.
Note: A patient may be re-screened (once only) after the infection has resolved;
5. Diagnosed with or suspected of active tuberculosis, latent untreated tuberculosis,
incompletely treated tuberculosis, or nontuberculous mycobacterial infection based on
the investigator and/or infectious disease specialist's judgment (as indicated by
medical history, symptoms, signs, laboratory tests, X-ray or CT findings) (except
subjects with treatment records demonstrating adequate treatment, who may begin
treatment with biological product based on the investigator and/or infectious disease
specialist's judgment);
6. History of parasite infestation/infection within 6 months prior to screening;
7. Prior (within 5 years prior to screening) or current malignant tumors (except for
completely resected squamous cell carcinoma of skin, basal cell carcinoma, or cervical
carcinoma in situ with no evidence of recurrence);
8. Severe, progressive, and uncontrolled cardiovascular, cerebrovascular, hepatic, renal,
lung, gastrointestinal, hematopoietic, endocrine, nervous system, and psychiatric
disorders, as well as other conditions that are unsuitable for study participation, as
judged by the investigator.
4. Used any of the following drugs/treatments or participated in a clinical study (defined
as having signed informed consent form and received treatment with a drug/medical device at
least once): Received treatment with other biological products targeting IL-4Ra or
participated in a clinical study involving another biological product targeting IL-4Ra;
1. Received treatment with an investigational drug (such as JAK inhibitors) or medical
device within 8 weeks or 5 half-lives prior to baseline (whichever is longer);
2. Received treatment with systemic corticosteroids or immunosuppressants for atopic
dermatitis within 4 weeks prior to baseline;
3. Received systemic treatment with Traditional Chinese medicine for atopic dermatitis
within 4 weeks prior to baseline;
4. Received ultraviolet phototherapy (including but not limited to narrow-band
ultraviolet B phototherapy (NB-UVB) and medium- to high-dose UVA1) or regular use of
tanning booth/parlor for atopic dermatitis within 4 weeks prior to baseline;
5. Used bleach baths = 2 times within 2 weeks prior to baseline;
6. Received the following topical medications for atopic dermatitis within 1 week prior
to baseline:
1. Topical corticosteroids or topical calcineurin inhibitors;
2. Topical traditional Chinese medicine;
3. Other topical medications (including but not limited to phosphodiesterase 4
(PDE-4) inhibitor);
7. Received treatment with the following biological products prior to baseline:
1. Any cell depletion therapy, including but not limited to rituximab: within 6
months prior to baseline or until lymphocyte count returns to normal (whichever
is longer);
2. Other biological products: within 5 half-lives (if the half-life is known) or 16
weeks prior to baseline (whichever is longer);
8. Received allergen-specific immunotherapy within 6 weeks prior to baseline;
9. Received treatment with leukotriene inhibitors within 4 weeks prior to baseline;
10. Started treatment with prescription emollients or emollients containing active
ingredients (such as ceramide, hyaluronic acid, urea, or filaggrin breakdown products)
during the screening period (patients may continue to use these types of emollients at
stable doses if they have already been using them prior to the screening visit);
11. Underwent major surgery within 3 months prior to baseline or have not recovered, or
plan to undergo major surgery during the course of the study;
12. History of blood donation or severe blood loss (total blood loss = 500 mL) within 1
month prior to screening, or received blood transfusion within 2 months prior to
screening;
13. Received a live attenuated vaccine/live vaccine within 12 weeks prior to baseline, or
plan to receive a live attenuated vaccine/live vaccine during the course of the study,
or participated in a vaccine clinical trial within 12 weeks prior to baseline.
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