Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Moderate-to-severe Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893941
• Other study ID #: CM310AD001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 21, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: June 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 multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.

Description:

The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 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

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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Shanghai Skin Disease Hospital	Shanghai
China	Wuxi Second Hospital	Wuxi	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	Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)	Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	Baseline to Week 12
Secondary	Pharmacokinetics parameter: Peak concentration (Cmax)	Peak concentration (Cmax)	Baseline to Week 12
Secondary	Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to 8 (AUC0-8)	Area under the plasma concentration-time curve from 0 to 8 (AUC0-8)	Baseline to Week 12
Secondary	Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)	Area under the plasma concentration-time curve from 0 to t (AUC0-t)	Baseline to Week 12
Secondary	Pharmacokinetics parameter: Clearance rate (CL/F)	Clearance rate (CL/F)	Baseline to Week 12
Secondary	Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)	Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)	Baseline to Week 12
Secondary	Pharmacodynamics parameters: Blood eosinophil count (EOS)	Blood eosinophil count (EOS)	Baseline to Week 12
Secondary	Pharmacodynamics parameters: Total IgE level	Total IgE level	Baseline to Week 12
Secondary	Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)	Proportion of Participants with anti-drug antibody (ADA)	Baseline to Week 12
Secondary	Preliminary efficacy: Proportion of subjects with IGA 0 or 1	Proportion of subjects with Investigator's Global Assessment (IGA, on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) 0 or 1	Baseline to Week 12
Secondary	Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of = 2 points	Proportion of subjects with a reduction of IGA from baseline of = 2 points	Baseline to Week 12
Secondary	Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of = 2 points	Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of = 2 points	Baseline to Week 12
Secondary	Preliminary efficacy: Proportion of subjects with EASI-50	Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (=50 percent improvement from baseline)	Baseline to Week 12
Secondary	Preliminary efficacy: Proportion of subjects with EASI-75	Proportion of subjects with EASI-75 (=75 percent improvement from baseline)	Baseline to Week 12
Secondary	Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline	Proportion of subjects with improvement (reduction) of pruritus Numerical Rating Scale(NRS) from baseline; The range of NRS is from 0 (no itch)-10 (worst imaginable itch)	Baseline to Week 12