Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis

Keymed Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT06162507

CM310-101010

Details and patient eligibility

About

This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.

Enrollment: 24 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With atopic dermatis.
• Voluntarily sign the informed consent form.

Exclusion criteria

• Any major surgery planned during the research period.
• With intestinal parasitic infection within the first 6 months of screening.
• With any previous malignant tumors prior to screening.
• With any circumstance that is not suitable to participate in this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

CM310 group A

Experimental group

Description:

CM310 injection, subcutaneous injection, once every 3 weeks.

Treatment:

Biological: CM310

CM310 group B

Experimental group

Description:

CM310 injection, subcutaneous injection, once every 2 weeks.

Treatment:

Biological: CM310