Clinical trial NCT04805411: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Keywords: Atopic dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: EASI-75
timeFrame: at Week 16
Secondary outcomes:
measure: Investigator's Global Assessment (IGA) 0/1
timeFrame: at week 16
measure: reduction of IGA from baseline of ≥ 2 points
timeFrame: at week 16
measure: The Eczema Area and Severity Index (EASI)-90
timeFrame: at week 16
measure: The Eczema Area and Severity Index (EASI)-50
timeFrame: at week 16
measure: Improvement of Numerical Rating Scale (NRS)
timeFrame: at week 16
measure: Body Surface Area (BSA)
timeFrame: Baseline to Week 24
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to Week 24
measure: Safety parameters
timeFrame: Baseline to Week 24
measure: Pharmacokinetics parameters
timeFrame: Baseline to Week 24
measure: Pharmacodynamics
timeFrame: Baseline to Week 24
measure: Pharmacodynamics
timeFrame: Baseline to Week 24
measure: immunogenicity
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital，Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: Wuxi Second Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: Second Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital of Dermatology
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Second Hospital
state: Zhejiang
Study officials:
References: