Moderate-to-severe Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis
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.
Interventions
BIOLOGICALCM310
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.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[(a 6-point scale ranging from 0 (clear) to 5 (very severe)\] |
| 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 |
| 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 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) |
| 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) |
| 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) |
| 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 |
| Body Surface Area (BSA) | Up to 2 Years | Change from baseline in percent of BSA |
| Time to first remission (achieving IGA = 0 or 1) | Up to 2 Years | — |
| 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 | — |
| Number of days on topical medication (per patient-year) | Up to 2 Years | — |
| 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 |
| immunogenicity | Up to 2 Years | Detection of anti-drug antibody (ADA) |
| Pharmacokinetics parameters | Up to 2 Years | trough concentration of CM310 |
| Percent change from baseline in NRS | Up to 2 Years | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) |
Countries
China
Outcome results
None listed