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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805411
Recruitment Status : Completed
First Posted : March 18, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Keymed Biosciences Co.Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate-to-severe Atopic Dermatitis Biological: CM310 Biological: Placebo Phase 2

Detailed Description:
Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : February 24, 2021
Actual Primary Completion Date : November 8, 2021
Actual Study Completion Date : November 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: High-dose arm
600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC
 Biological: CM310
IL-4Rα monoclonal antibody
Experimental: low-dose arm
300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC
 Biological: CM310
IL-4Rα monoclonal antibody
Placebo Comparator: placebo
placebo for 1-8 doses, every 2 weeks, SC
 Biological: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. EASI-75 [ Time Frame: at Week 16 ]
    Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805411


Locations
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Sponsors and Collaborators
Keymed Biosciences Co.Ltd
More Information
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Responsible Party: Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier: NCT04805411    
Other Study ID Numbers: CM310AD002
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keymed Biosciences Co.Ltd:
Atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases