Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stapokibatrt group

Group Type EXPERIMENTAL

Stapokibatrt

Intervention Type BIOLOGICAL

Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo of matching volume，Subcutaneous injection(SC)

Interventions

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Stapokibatrt

Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)

Intervention Type BIOLOGICAL

Placebo

Placebo of matching volume，Subcutaneous injection(SC)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No