Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
NCT06956196 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2025-05-04
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
Interventions
- BIOLOGICAL
-
Stapokibatrt
Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)
- OTHER
-
Placebo
Placebo of matching volume,Subcutaneous injection(SC)
Sponsors & Collaborators
-
Keymed Biosciences Co.Ltd
lead INDUSTRY
Principal Investigators
-
Lin Ma · Beijing Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2026-05-31
- Completion
- 2026-08-31
Countries
- China
Study Locations
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