Not yet recruiting NCT07106372
A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stapokibatrt.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 2 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Stapokibatrt in Children With Atopic Dermatitis
Overview
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
- Biological Stapokibatrt
Stapokibatrt Subcutaneous injection
Primary outcome measures
- Adverse events [Time frame: up to week 44]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Children's Hospital Capital Medical University — Beijing
Identifiers
NCT: NCT07106372 · CM310-101218