A 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

2025-09-30

Study Completion Date

2027-06-30

Brief Summary

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This is a multi-center, single-arm, open-label phase 3 study to evaluate the safety, efficacy, Pharmacokinetics(PK) and immunogenicity of Stapokibatrt in children with 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stapokibatrt group

Group Type EXPERIMENTAL

Stapokibatrt

Intervention Type BIOLOGICAL

Stapokibatrt Subcutaneous injection

Interventions

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Stapokibatrt

Stapokibatrt Subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Voluntarily participate in the continuing study and sign the written Informed Consent Form(ICF).
* Subjects who must complete the evaluation of Week 18 of the main study.
* Have the ability to communicate well with the researcher and comply with the follow-up visits of the protocol.

Exclusion Criteria

* Planned major surgical procedure during the patient's participation in this study.
* Any other circumstances in which the researcher deems not suitable to participate in this study.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No