Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

Phase 3

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Biological: Stapokibatrt; Other: Placebo

• Registration Number: NCT06956196
• Lead Sponsor: Keymed Biosciences Co.Ltd

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 children with moderate-to-severe atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study Start: 2025-05
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-05
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapokibatrt group	Stapokibatrt	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18	Up to week 18	The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).

Trial Locations

Locations (1)

Beijing Children's Hospital Capital Medical University; 🇨🇳 Beijing, China