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Completed

NCT Number: NCT06116565

A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects 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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

About this study

The study consists of an screening period, treatment period, and safety follow-up period.

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).
  • Age ≥ 18 and ≤ 75 years old.
  • With Atopic Dermatitis.

Exclusion criteria

  • Not enough washing-out period for previous therapy.
  • Concurrent disease/status which may potentially affect the efficacy/safety judgement.
  • Major surgeries are planned during the study period.

Treatment and study plan

CM310

Biological

CM310, subcutaneous injection

Primary outcomes

  1. Adverse events (AEs)

    Time frame: up to Week 60

    Incidence of adverse events (AEs).

Secondary outcomes

  1. Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit

    Time frame: up to Week 60

  2. Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit

    Time frame: up to Week 60

  3. Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit

    Time frame: up to Week 60

  4. Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit

    Time frame: up to Week 60

  5. Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

    Time frame: up to Week 60

  6. Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

    Time frame: up to Week 60

  7. Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

    Time frame: up to Week 60

  8. Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores

    Time frame: up to Week 60

  9. Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores

    Time frame: up to Week 60

  10. Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores

    Time frame: up to Week 60

  11. Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit

    Time frame: up to Week 60

  12. Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit

    Time frame: up to Week 60

  13. Trough concentration (Ctrough) of CM310

    Time frame: up to Week 60

  14. Incidence of treatment-emergent anti-drug antibodies (ADA)

    Time frame: up to Week 60

  15. Incidence of neutralizing antibodies (NAb)

    Time frame: up to Week 60

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2023
Registry last updated
Aug 20, 2026

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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