A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Biological: Stapokibatrt

Study type: Interventional

Funder types: Industry

Identifiers

NCT07106372

CM310-101218

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

240 participants in 1 patient group

Stapokibatrt group

Experimental group

Treatment:

Biological: Stapokibatrt