Atopic Dermatitis
Conditions
Brief summary
This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.
Interventions
BIOLOGICALCM326
CM326 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
* With confirmed Atopic Dermatitis (AD) at the screening. * Have the ability to understand the nature of the study and voluntarily sign the informed consent. * Be able to communicate well with investigators and follow up protocol requirements. * The subjects agreed to use highly effective contraceptive measures during the study.
Exclusion criteria
* Not enough washing-out period for previous therapy. * Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline. * Major surgery is planned during the study period. * Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | at week 52 | Incidence of treatment-emergent Adverse events related to CM326 |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed