Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorKeymed Biosciences Co.Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Stapokibatrt
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov