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NCT Number: NCT04805411

Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.

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Key information

Conditions

Moderate-to-severe 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
  • Inadequate response to topical medications.

Exclusion criteria

  • Not enough washing-out period for previous therapy.
  • Concurrent disease/status which may potentially affect the efficacy/safety judgement.
  • Organ dysfunction.
  • pregnancy.
  • Other.

Treatment and study plan

CM310

Biological

IL-4Rα monoclonal antibody

Placebo

Biological

Placebo

Primary outcomes

  1. EASI-75

    Time frame: at Week 16

    Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)

Secondary outcomes

  1. Investigator's Global Assessment (IGA) 0/1

    Time frame: at week 16

    Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points.

  2. reduction of IGA from baseline of ≥ 2 points

    Time frame: at week 16

    Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points.

  3. The Eczema Area and Severity Index (EASI)-90

    Time frame: at week 16

    Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)

  4. The Eczema Area and Severity Index (EASI)-50

    Time frame: at week 16

    Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)

  5. Improvement of Numerical Rating Scale (NRS)

    Time frame: at week 16

    Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).

  6. Body Surface Area (BSA)

    Time frame: Baseline to Week 24

    Change from baseline in percent of BSA

  7. Dermatology Life Quality Index (DLQI)

    Time frame: Baseline to Week 24

    Change from baseline in DLQI

  8. Safety parameters

    Time frame: Baseline to Week 24

    Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  9. Pharmacokinetics parameters

    Time frame: Baseline to Week 24

    trough concentration and exposure of CM310

  10. Pharmacodynamics

    Time frame: Baseline to Week 24

    Serum Thymus and activation regulated chemokine (TARC)

  11. Pharmacodynamics

    Time frame: Baseline to Week 24

    Total IgE level

  12. immunogenicity

    Time frame: Baseline to Week 24

    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 IIb Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Apr 15, 2022

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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