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OpenTrials
Active, Not Recruiting

NCT Number: NCT06495229

Study of CM310 in Adolescent Subjects With Atopic Dermatis

This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
  • Subjects who must complete the evaluation of Week 18 of the main study.
  • With Atopic Dermatitis.

Exclusion criteria

  • Any major surgery planned during the research period.
  • Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
  • With any circumstance that the subject is not suitable to participate in this study.

Treatment and study plan

CM310

Biological

Interleukin-4 receptor(IL-4Rα) monoclonal antibody

Primary outcomes

  1. Adverse events

    Time frame: up to week 52

    Incidence of adverse events.

Secondary outcomes

  1. Change from baseline in Eczema Area and Severity Index (EASI)

    Time frame: up to week 62

    Changes from baseline in Eczema Area and Severity Index (EASI)

  2. Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points

    Time frame: up to week 62

    Proportion of subjects with IGA 0 or 1 (on a 5-point scale, range from 0-4 point, higher scores mean a worse disease severity) and reduction ≥2 points from baseline.

  3. Improvement of Numerical Rating Scale (NRS)

    Time frame: up to week 62

    Proportion of subjects with improvement (reduction) of pruritus NRS from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).

  4. Body surface area (BSA) of involvement of atopic dermatitis

    Time frame: up to week 62

    Change from baseline in percent of BSA

  5. Children Dermatology Life Quality Index (CDLQI)

    Time frame: up to week 62

    Changes from baseline in CDLQI

  6. Patient-Oriented Eczema Measure (POEM)

    Time frame: up to week 62

    Changes from baseline in POEM

  7. EuroQol Five Dimensions Questionnaire (EQ-5D)

    Time frame: up to week 62

    Changes from baseline in EQ-5D

  8. Pharmacokinetics parameters

    Time frame: up to week 62

    Trough concentration and exposure of CM310

  9. Immunogenicity

    Time frame: up to week 62

    Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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