The Study of CM310 in Patients With Atopic Dermatitis

Moderate-to-severe Atopic Dermatitis Clinical Trial

Official title:

An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893707
• Other study ID #: CM310AD100
• Status: Recruiting
• Phase: Phase 2
• Start date: June 7, 2021
• Est. completion date: June 2023

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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 459
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• CM310
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.

Locations

Country	Name	City	State
China	Peking University People's hospital	Beijing

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	Number of Treatment Emergent Adverse Events (TEAEs)	The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs	Up to 2 Years
Secondary	Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)	Incidence and rate (events per patient-year) of SAEs and AESIs	Up to 2 Years
Secondary	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	Up to 2 Years
Secondary	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)]	Up to 2 Years
Secondary	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	Up to 2 Years
Secondary	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	Up to 2 Years
Secondary	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	Up to 2 Years
Secondary	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)	Up to 2 Years
Secondary	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)	Up to 2 Years
Secondary	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)	Up to 2 Years
Secondary	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)	Up to 2 Years
Secondary	Percent change from baseline in NRS	The range of NRS is from 0 (no itch)-10 (worst imaginable itch)	Up to 2 Years
Secondary	Body Surface Area (BSA)	Change from baseline in percent of BSA	Up to 2 Years
Secondary	Time to first remission (achieving IGA = 0 or 1)		Up to 2 Years
Secondary	Time to first relapse (eg, IGA >2) after remission or to not achieving remission		Up to 2 Years
Secondary	Time to first EASI-50/75/90		Up to 2 Years
Secondary	Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment		Up to 2 Years
Secondary	Number of days on topical medication (per patient-year)		Up to 2 Years
Secondary	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	Up to 2 Years
Secondary	immunogenicity	Detection of anti-drug antibody (ADA)	Up to 2 Years
Secondary	Pharmacokinetics parameters	trough concentration of CM310	Up to 2 Years