Atopic Dermatitis
Conditions
Brief summary
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Detailed description
This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.
Interventions
DRUGAK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)
Sponsors
Akeso
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
1. Male or female subjects aged ≥18≤75 years old. 2. Atopic dermatitis (AD) diagnosed at least half a year before screening. 3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline. 4. Subjects who are suitable for continue using biological treatment assessed by investigator
Exclusion criteria
1. Acute onset of AD within 4 weeks before drug administration. 2. The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study. 3. Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis 4. Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections. 5. Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration. 6. any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | through study completion, an average of 25 weeks | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) score | baseline to week 20 | Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema. |
| Investigator's Global Assessment (IGA) 0/1 | from baseline to week 20 | Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). |
| Affected body surface area (BSA) score | from baseline to week 20 | Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined. |
| Area under the curve(AUC) of AK120 | before drug administration at week 0/4/8/12/16 | Assessment of AUC of AK120. |
| Anti-drug antibodies (ADA) of AK120 | before drug administration at week 0/4/8/16/20 | Percentage of subjects with detectable anti drug antibodies (ADA) of AK120. |
Countries
China
Outcome results
None listed