Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.
Interventions
BIOLOGICALStapokibatrt
Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)
OTHERPlacebo
Placebo of matching volume，Subcutaneous injection(SC)
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 2 and ≤ 11 years old. * Diagnosis of AD according to the American Academy of Dermatology Consensus (2014) Criteria. * With moderate-to-severe AD, and inadequate response to topical medications.
Exclusion criteria
* Prior treatment with Stapokibart * Treatment with dupilumab within 13 weeks prior to the baseline visit, or treatment with anti-IgE(Immunoglobulin E) monoclonal antibody，other biological agents within 5 half-lives prior to the baseline visit . * Treatment with immunosuppressants/immunomodulatory drugs, ultraviolet therapy, or systemic traditional Chinese medicine for AD within 4 weeks prior to the baseline visit. * Treatment with a topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or topical Phosphodiesterase-4(PDE-4) inhibitor within 1 weeks prior to the baseline visit. * History of atopic keratoconjunctivitis invading cornea. * Acute attacks of Atopic Dermatitis within 4 weeks prior to the baseline visit. * Planned major surgical procedure during the patient's participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18 | Up to week 18 | The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of 0 (none) through 3 (severe). |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed