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

Moderate-to-severe Atopic Dermatitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805411
• Other study ID #: CM310AD002
• Status: Completed
• Phase: Phase 2
• Start date: February 24, 2021
• Est. completion date: November 8, 2021

Study information

• Verified date: November 2021
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-severe Atopic Dermatitis

Intervention

Biological:
• CM310
IL-4Ra monoclonal antibody
• Placebo
Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EASI-75	Proportion of subjects with EASI-75 (=75 percent improvement from baseline)	at Week 16
Secondary	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
Secondary	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
Secondary	The Eczema Area and Severity Index (EASI)-90	Proportion of subjects with EASI-90 (=90 percent improvement from baseline)	at week 16
Secondary	The Eczema Area and Severity Index (EASI)-50	Proportion of subjects with EASI-50 (=50 percent improvement from baseline)	at week 16
Secondary	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
Secondary	Body Surface Area (BSA)	Change from baseline in percent of BSA	Baseline to Week 24
Secondary	Dermatology Life Quality Index (DLQI)	Change from baseline in DLQI	Baseline to Week 24
Secondary	Safety parameters	Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Baseline to Week 24
Secondary	Pharmacokinetics parameters	trough concentration and exposure of CM310	Baseline to Week 24
Secondary	Pharmacodynamics	Serum Thymus and activation regulated chemokine (TARC)	Baseline to Week 24
Secondary	Pharmacodynamics	Total IgE level	Baseline to Week 24
Secondary	immunogenicity	Detection of anti-drug antibody (ADA)	Baseline to Week 24