Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stapokibatrt, Placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 2 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Stapokibatrt in Children With Moderate-to-severe Atopic Dermatitis
Overview
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
- Biological Stapokibatrt
Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC) - Other Placebo
Placebo of matching volume，Subcutaneous injection(SC)
Primary outcome measures
- Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18 [Time frame: Up to week 18]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Children's Hospital Capital Medical University — Beijing
Identifiers
NCT: NCT06956196 · CM310-101217