A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

A Multi-center, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Stapokibatrt in Children With Atopic Dermatitis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07106372

Enrollment

240

Registered

2025-08-06

Start date

2025-09-30

Completion date

2027-06-30

Last updated

2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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.

Interventions

BIOLOGICALStapokibatrt

Stapokibatrt Subcutaneous injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	up to week 44	Incidence of adverse events

Countries

China

Contacts

Primary ContactQian Jia

qianjia@keymedbio.com028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026