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CompletedNCT05579925Updated Nov 8, 2024

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

A Phase 2 interventional study of CM310 in Atopic Dermatitis, sponsored by Keymed Biosciences Co.Ltd. Completed at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Keymed Biosciences Co.Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 24 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 63 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Weight \< 30 kg
  • Major surgery planed during the study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    CM310

    600 mg + 300 mg, subcutaneous injection, once every two weeks

    Biological: CM310

Interventions

  • BiologicalCM310

    CM310 600 mg + 300 mg, subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Adverse events

    Incidence of adverse events.

    Time frame: at week 14

07

Study locations

1 site
  • Beijing Children's Hospital Capital Medical University
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05579925
Lead sponsor
Keymed Biosciences Co.Ltd
Responsible party
Sponsor
First posted
Oct 14, 2022
Start date
Oct 7, 2022
Primary completion
Jul 28, 2023
Completion
Jul 28, 2023
Last update
Nov 8, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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