Atopic Dermatitis
Conditions
Brief summary
This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.
Detailed description
The study consists of an screening period, treatment period, and safety follow-up period.
Interventions
BIOLOGICALCM310
CM310, subcutaneous injection
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). * Age ≥ 18 and ≤ 75 years old. * With Atopic Dermatitis.
Exclusion criteria
* Not enough washing-out period for previous therapy. * Concurrent disease/status which may potentially affect the efficacy/safety judgement. * Major surgeries are planned during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | up to Week 60 | Incidence of adverse events (AEs). |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit | up to Week 60 |
| Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit | up to Week 60 |
| Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit | up to Week 60 |
| Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit | up to Week 60 |
| Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit | up to Week 60 |
| Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit | up to Week 60 |
| Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit | up to Week 60 |
| Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores | up to Week 60 |
| Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores | up to Week 60 |
| Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores | up to Week 60 |
| Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit | up to Week 60 |
| Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit | up to Week 60 |
| Trough concentration (Ctrough) of CM310 | up to Week 60 |
| Incidence of treatment-emergent anti-drug antibodies (ADA) | up to Week 60 |
| Incidence of neutralizing antibodies (NAb) | up to Week 60 |
Countries
China
Outcome results
None listed