The Study of CM310 in Patients With Atopic Dermatitis
- Registration Number
- NCT04893707
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
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Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:
- Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
- 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 .
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Provide signed informed consent
- 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.
- Not enough washing-out period for previous therapy.
- Pregnancy.
- Other
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM310 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.
- Primary Outcome Measures
Name Time Method Number of Treatment Emergent Adverse Events (TEAEs) Up to 2 Years The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs
- Secondary Outcome Measures
Name Time Method Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI) Up to 2 Years Incidence and rate (events per patient-year) of SAEs and AESIs
Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI) Up to 2 Years 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
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 Up to 2 Years 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
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit Up to 2 Years Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale \[(a 6-point scale ranging from 0 (clear) to 5 (very severe)\]
Change from baseline in EASI score at each visit Up to 2 Years 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
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline Up to 2 Years 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)
Body Surface Area (BSA) Up to 2 Years Change from baseline in percent of BSA
Time to first relapse (eg, IGA >2) after remission or to not achieving remission Up to 2 Years Time to first EASI-50/75/90 Up to 2 Years Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment Up to 2 Years immunogenicity Up to 2 Years Detection of anti-drug antibody (ADA)
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 Up to 2 Years 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
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 Up to 2 Years 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
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline Up to 2 Years The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Pharmacokinetics parameters Up to 2 Years trough concentration of CM310
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit Up to 2 Years IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit Up to 2 Years IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)
Percent change from baseline in NRS Up to 2 Years The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time to first remission (achieving IGA = 0 or 1) Up to 2 Years Number of days on topical medication (per patient-year) Up to 2 Years
Trial Locations
- Locations (1)
Peking University People's hospital
🇨🇳Beijing, China