NCT06956196Not yet recruitingPhase 3
Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
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
Source: ClinicalTrials.gov · Last updated 4 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- May 2025
- Primary completion date
- May 2026
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06956196
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 240
- From May 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of atopic keratoconjunctivitis invading cornea.
Who the study is looking for
- 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.
Age in the registry: 2 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.