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

Primary Purpose

Moderate-to-severe Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM310
Placebo
Sponsored by
Keymed Biosciences Co.Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate-to-severe Atopic Dermatitis focused on measuring Atopic dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-Yang Hospital, Capital Medical University
  • Beijing Friendship Hospital，Capital Medical University
  • Peking University People's Hospital
  • Peking University Third Hospital
  • Chongqing Traditional Chinese Hospital
  • Dermatology Hospital of Southern Medical University
  • Second Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South University
  • Wuxi Second Hospital
  • Affiliated Hospital of Jiangsu University
  • First Hospital of Jilin University
  • Second Hospital of Jilin University
  • Qilu Hospital of Shandong University
  • Shandong Provincial Hospital of Dermatology
  • Affiliated Hospital of Qingdao University
  • Yantai Yuhuangding Hospital
  • Shanghai Skin Disease Hospital
  • Second Hospital of Shanxi Medical University
  • West China Hospital of Sichuan University
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Hangzhou First People's Hospital
  • Second Affiliated Hospital Zhejiang University School of Medicine
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Zhejiang Provincial People's Hospital
  • Ningbo Second Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High-dose arm

low-dose arm

placebo

Arm Description

600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC

300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC

placebo for 1-8 doses, every 2 weeks, SC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Investigator's Global Assessment (IGA) 0/1
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.
reduction of IGA from baseline of ≥ 2 points
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.
The Eczema Area and Severity Index (EASI)-90
Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)
The Eczema Area and Severity Index (EASI)-50
Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)
Improvement of Numerical Rating Scale (NRS)
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).
Body Surface Area (BSA)
Change from baseline in percent of BSA
Dermatology Life Quality Index (DLQI)
Change from baseline in DLQI
Safety parameters
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Pharmacokinetics parameters
trough concentration and exposure of CM310
Pharmacodynamics
Serum Thymus and activation regulated chemokine (TARC)
Pharmacodynamics
Total IgE level
immunogenicity
Detection of anti-drug antibody (ADA)

Full Information

First Posted
March 14, 2021
Last Updated
April 13, 2022
Sponsor
Keymed Biosciences Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04805411
Brief Title
Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-severe Atopic Dermatitis
Keywords
Atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dose arm
Arm Type
Experimental
Arm Description
600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC
Arm Title
low-dose arm
Arm Type
Experimental
Arm Description
300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo for 1-8 doses, every 2 weeks, SC
Intervention Type
Biological
Intervention Name(s)
CM310
Intervention Description
IL-4Rα monoclonal antibody
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
EASI-75
Description
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
Time Frame
at Week 16
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) 0/1
Description
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.
Time Frame
at week 16
Title
reduction of IGA from baseline of ≥ 2 points
Description
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.
Time Frame
at week 16
Title
The Eczema Area and Severity Index (EASI)-90
Description
Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)
Time Frame
at week 16
Title
The Eczema Area and Severity Index (EASI)-50
Description
Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)
Time Frame
at week 16
Title
Improvement of Numerical Rating Scale (NRS)
Description
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).
Time Frame
at week 16
Title
Body Surface Area (BSA)
Description
Change from baseline in percent of BSA
Time Frame
Baseline to Week 24
Title
Dermatology Life Quality Index (DLQI)
Description
Change from baseline in DLQI
Time Frame
Baseline to Week 24
Title
Safety parameters
Description
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time Frame
Baseline to Week 24
Title
Pharmacokinetics parameters
Description
trough concentration and exposure of CM310
Time Frame
Baseline to Week 24
Title
Pharmacodynamics
Description
Serum Thymus and activation regulated chemokine (TARC)
Time Frame
Baseline to Week 24
Title
Pharmacodynamics
Description
Total IgE level
Time Frame
Baseline to Week 24
Title
immunogenicity
Description
Detection of anti-drug antibody (ADA)
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital，Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Traditional Chinese Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Wuxi Second Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shandong Provincial Hospital of Dermatology
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
Country
China
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Ningbo Second Hospital
City
Ningbo
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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