Tests stapokibatrt in children with moderate-to-severe atopic dermatitis
Tests stapokibatrt against placebo in children aged 2 to 11 with eczema.
Plain-language title generated from the registry record
Registry title: Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 11 years old?
Source: NCT06956196, who can take part
Where in China
- Beijing Children's Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Keymed Biosciences Co.Ltd
- Trial code
- NCT06956196
- Record updated
- 4 May 2025
- Original description
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.Read full original descriptionShow less
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
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.
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; 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; History of atopic keratoconjunctivitis invading cornea.