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The Study of CM310 in Patients With Atopic Dermatitis

Primary Purpose

Moderate-to-severe Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM310
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:

    1. Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
    2. Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit .
  2. Provide signed informed consent

Exclusion Criteria:

  1. Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310.
  2. Not enough washing-out period for previous therapy.
  3. Pregnancy.
  4. Other

Sites / Locations

  • Peking University People's hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CM310

Arm Description

adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.

Outcomes

Primary Outcome Measures

Number of Treatment Emergent Adverse Events (TEAEs)
The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs

Secondary Outcome Measures

Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)
Incidence and rate (events per patient-year) of SAEs and AESIs
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit
Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)]
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Change from baseline in EASI score at each visit
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline
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)
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Percent change from baseline in NRS
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Body Surface Area (BSA)
Change from baseline in percent of BSA
Time to first remission (achieving IGA = 0 or 1)
Time to first relapse (eg, IGA >2) after remission or to not achieving remission
Time to first EASI-50/75/90
Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment
Number of days on topical medication (per patient-year)
Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL
immunogenicity
Detection of anti-drug antibody (ADA)
Pharmacokinetics parameters
trough concentration of CM310

Full Information

First Posted
May 15, 2021
Last Updated
November 11, 2021
Sponsor
Keymed Biosciences Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04893707
Brief Title
The Study of CM310 in Patients With Atopic Dermatitis
Official Title
An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

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 an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).
Detailed Description
The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
459 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CM310
Arm Type
Experimental
Arm Description
adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.
Intervention Type
Biological
Intervention Name(s)
CM310
Other Intervention Name(s)
IL-4Rα monoclonal antibody
Intervention Description
adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs
Time Frame
Up to 2 Years
Secondary Outcome Measure Information:
Title
Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)
Description
Incidence and rate (events per patient-year) of SAEs and AESIs
Time Frame
Up to 2 Years
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to 2 Years
Title
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit
Description
Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)]
Time Frame
Up to 2 Years
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to 2 Years
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to 2 Years
Title
Change from baseline in EASI score at each visit
Description
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Time Frame
Up to 2 Years
Title
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
Description
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Time Frame
Up to 2 Years
Title
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
Description
IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Time Frame
Up to 2 Years
Title
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline
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
Up to 2 Years
Title
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline
Description
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time Frame
Up to 2 Years
Title
Percent change from baseline in NRS
Description
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time Frame
Up to 2 Years
Title
Body Surface Area (BSA)
Description
Change from baseline in percent of BSA
Time Frame
Up to 2 Years
Title
Time to first remission (achieving IGA = 0 or 1)
Time Frame
Up to 2 Years
Title
Time to first relapse (eg, IGA >2) after remission or to not achieving remission
Time Frame
Up to 2 Years
Title
Time to first EASI-50/75/90
Time Frame
Up to 2 Years
Title
Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment
Time Frame
Up to 2 Years
Title
Number of days on topical medication (per patient-year)
Time Frame
Up to 2 Years
Title
Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)
Description
The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL
Time Frame
Up to 2 Years
Title
immunogenicity
Description
Detection of anti-drug antibody (ADA)
Time Frame
Up to 2 Years
Title
Pharmacokinetics parameters
Description
trough concentration of CM310
Time Frame
Up to 2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following: Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit. Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit . Provide signed informed consent Exclusion Criteria: Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310. Not enough washing-out period for previous therapy. Pregnancy. Other
Facility Information:
Facility Name
Peking University People's hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang
Phone
15545433012
Email
rmzjz@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Study of CM310 in Patients With Atopic Dermatitis

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