Atopic Dermatitis
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.
Interventions
DRUGAK120
subcutaneous injection once a week
DRUGPlacebo
subcutaneous injection once a week.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female with age 18 - 75 years (inclusive). 2. Atopic dermatitis (AD) diagnosed at least half an year before screening. 3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline. 4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
Exclusion criteria
1. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.). 2. History of exposure to active TB, and/or history or current evidence of TB infection. 3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV. 4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit. 5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit 6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib | Baseline to week 12 | Incidence of treatment emergent AE . 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. |
| Phase II | at week 16 | Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75 |
| Phase II Extension Study | Baseline to week 24 | Incidence of treatment emergent AE . 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 |
|---|---|---|
| Phase Ib | Baseline to week 12 | Percentage of subjects with detectable anti AK120 antibodies (ADA). |
| Phase II | Baseline to week 58 | Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit. Higher score mean better outcome, lower score mean worse outcome |
| Phase II Extension Study | Baseline to week 24 | Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit. Higher score mean better outcome, lower score mean worse outcome |
Countries
China
Outcome results
None listed