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

A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05579925
Enrollment
24
Registered
2022-10-14
Start date
2022-10-07
Completion date
2023-07-28
Last updated
2024-11-08

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 study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.

Interventions

BIOLOGICALCM310

CM310 600 mg + 300 mg, subcutaneous injection

Sponsors

Keymed Biosciences Co.Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 12 years ≤ age ≤ 18 years * With atopic dermatis * Voluntarily sign the informed consent form

Exclusion criteria

* Weight \< 30 kg * Major surgery planed during the study

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsat week 14Incidence of adverse events.

Countries

China

Outcome results

None listed

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