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Completed

NCT Number: NCT06277765

Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

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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).
  • With Atopic Dermatitis.

Exclusion criteria

  • Not enough washing-out period for previous therapies.
  • Any major surgery planned during the research period.
  • With intestinal parasitic infection within the 6 months before screening.
  • With any circumstance that is not suitable to participate in this study.
  • Major surgeries are planned during the study period.

Treatment and study plan

CM310

Biological

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

Placebo

Other

Placebo

Primary outcomes

  1. Proportion of subjects achieving EASI-75 at week 18

    Time frame: Up to week 18

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).

  2. Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline

    Time frame: up to week 18

    Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Secondary outcomes

  1. Percent change of Eczema Area and Severity Index (EASI) score from baseline

    Time frame: up to week 18

    The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).

  2. Percent change of NRS score from baseline

    Time frame: up to week 18

    The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)

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

    Time frame: up to week 18

    Change from baseline in percent of BSA

  4. Children Dermatology Life Quality Index (CDLQI)

    Time frame: up to week 18

    Changes from baseline in CDLQI

  5. Patient-Oriented Eczema Measure (POEM)

    Time frame: up to week 18

    Changes from baseline in POEM

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

    Time frame: up to week 18

    Changes from baseline in EQ-5D

  7. Safety parameters

    Time frame: up to week 26

    Incidence of Adverse Event(AE), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  8. Pharmacokinetics parameters

    Time frame: up to week 26

    Trough concentration and exposure of CM310

  9. Pharmacodynamics

    Time frame: up to week 26

    Serum concentration of Thymus and activation regulated chemokine (TARC) , total immunoglobulin E (IgE) and lactate dehydrogenase (LDH)

  10. Immunogenicity

    Time frame: up to week 26

    Detection of anti-drug antibody (ADA)

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 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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