Status:
NOT_YET_RECRUITING
Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06956196
Start Date
May 1 2025
End Date
August 1 2026
Last Update
May 4 2025
Active Locations (1)
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1
Beijing Children's Hospital Capital Medical University
Beijing, China