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

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)

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.

Study Overview

• Status: Completed
• Conditions: Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Biological: Placebo; Biological: CM310

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Friendship Hospital,Capital Medical University
    • Beijing, Beijing, China
      • Peking University Third Hospital
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China
      • Beijing Chao-Yang Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China
      • Chongqing Traditional Chinese Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Dermatology Hospital of Southern Medical University
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Second Xiangya Hospital of Central South University
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Wuxi Second Hospital
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Jilin
    • Changchun, Jilin, China
      • First Hospital of Jilin University
    • Changchun, Jilin, China
      • Second Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital Of Shandong University
    • Jinan, Shandong, China
      • Shandong Provincial Hospital of Dermatology
    • Qingdao, Shandong, China
      • Affiliated Hospital of Qingdao University
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai skin disease hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital ZheJiang University School of Medicine
    • Ningbo, Zhejiang, China
      • Ningbo second hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI-75	Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)	at Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at week 16
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.	at week 16
The Eczema Area and Severity Index (EASI)-90	Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)	at week 16
The Eczema Area and Severity Index (EASI)-50	Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)	at week 16
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).	at week 16
Body Surface Area (BSA)	Change from baseline in percent of BSA	Baseline to Week 24
Dermatology Life Quality Index (DLQI)	Change from baseline in DLQI	Baseline to Week 24
Safety parameters	Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Baseline to Week 24
Pharmacokinetics parameters	trough concentration and exposure of CM310	Baseline to Week 24
Pharmacodynamics	Serum Thymus and activation regulated chemokine (TARC)	Baseline to Week 24
Pharmacodynamics	Total IgE level	Baseline to Week 24
immunogenicity	Detection of anti-drug antibody (ADA)	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CM310AD002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No