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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
127
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.
Peking University People's hospital
Beijing, China
Number of Treatment Emergent Adverse Events (TEAEs)
The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs
Time frame: Up to 2 Years
Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)
Incidence and rate (events per patient-year) of SAEs and AESIs
Time frame: Up to 2 Years
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
Time frame: Up to 2 Years
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 \[(a 6-point scale ranging from 0 (clear) to 5 (very severe)\]
Time frame: Up to 2 Years
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
Time frame: Up to 2 Years
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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
Time frame: Up to 2 Years
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
Time frame: Up to 2 Years
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)
Time frame: Up to 2 Years
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)
Time frame: Up to 2 Years
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)
Time frame: Up to 2 Years
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)
Time frame: Up to 2 Years
Percent change from baseline in NRS
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time frame: Up to 2 Years
Body Surface Area (BSA)
Change from baseline in percent of BSA
Time frame: Up to 2 Years
Time to first remission (achieving IGA = 0 or 1)
Time frame: Up to 2 Years
Time to first relapse (eg, IGA >2) after remission or to not achieving remission
Time frame: Up to 2 Years
Time to first EASI-50/75/90
Time frame: Up to 2 Years
Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment
Time frame: Up to 2 Years
Number of days on topical medication (per patient-year)
Time frame: Up to 2 Years
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
Time frame: Up to 2 Years
immunogenicity
Detection of anti-drug antibody (ADA)
Time frame: Up to 2 Years
Pharmacokinetics parameters
trough concentration of CM310
Time frame: Up to 2 Years