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Completed

NCT Number: NCT04893941

Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.

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Key information

Conditions

Moderate-to-severe Atopic Dermatitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Second Xiangya Hospital of Central South University, Changsha, Hunan, China

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About this study

The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.

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

Drug

IL-4Rα monoclonal antibody

Placebo

Drug

Placebo

Primary outcomes

  1. Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)

    Time frame: Baseline to Week 12

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

Secondary outcomes

  1. Pharmacokinetics parameter: Peak concentration (Cmax)

    Time frame: Baseline to Week 12

    Peak concentration (Cmax)

  2. Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)

    Time frame: Baseline to Week 12

    Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)

  3. Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)

    Time frame: Baseline to Week 12

    Area under the plasma concentration-time curve from 0 to t (AUC0-t)

  4. Pharmacokinetics parameter: Clearance rate (CL/F)

    Time frame: Baseline to Week 12

    Clearance rate (CL/F)

  5. Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)

    Time frame: Baseline to Week 12

    Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)

  6. Pharmacodynamics parameters: Blood eosinophil count (EOS)

    Time frame: Baseline to Week 12

    Blood eosinophil count (EOS)

  7. Pharmacodynamics parameters: Total IgE level

    Time frame: Baseline to Week 12

    Total IgE level

  8. Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)

    Time frame: Baseline to Week 12

    Proportion of Participants with anti-drug antibody (ADA)

  9. Preliminary efficacy: Proportion of subjects with IGA 0 or 1

    Time frame: Baseline to Week 12

    Proportion of subjects with Investigator's Global Assessment (IGA, on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) 0 or 1

  10. Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points

    Time frame: Baseline to Week 12

    Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points

  11. Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points

    Time frame: Baseline to Week 12

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

  12. Preliminary efficacy: Proportion of subjects with EASI-50

    Time frame: Baseline to Week 12

    Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline)

  13. Preliminary efficacy: Proportion of subjects with EASI-75

    Time frame: Baseline to Week 12

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

  14. Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline

    Time frame: Baseline to Week 12

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

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Jun 4, 2021

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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