NCT06956196

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	Stapokibatrt	Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)
OTHER	Placebo	Placebo of matching volume，Subcutaneous injection(SC)

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

1 site across 1 country: China