NCT07106372

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
12mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

August 5, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Incidence of adverse events

    up to week 44

Study Arms (1)

Stapokibatrt group

EXPERIMENTAL
Biological: Stapokibatrt

Interventions

StapokibatrtBIOLOGICAL

Stapokibatrt Subcutaneous injection

Stapokibatrt group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lin Ma

    Beijing Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620qianjia@keymedbio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 6, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations

CN(1)