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
Overview
- Phase
- Phase 1
- Intervention
- AK120
- Conditions
- Atopic Dermatitis
- Sponsor
- Akeso
- Enrollment
- 427
- Locations
- 39
- Primary Endpoint
- Phase Ib
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female with age 18 - 75 years (inclusive).
- •Atopic dermatitis (AD) diagnosed at least half an year before screening.
- •Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- •Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.
Exclusion Criteria
- •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.).
- •History of exposure to active TB, and/or history or current evidence of TB infection.
- •Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
- •Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
- •History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
- •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.
Arms & Interventions
AK120 150 mg in phase Ib
subcutaneous injection once a week for 4 weeks.
Intervention: AK120
AK120 300mg in phase Ib
subcutaneous injection once a week for 4 weeks.
Intervention: AK120
Placebo Comparator: Placebo in phase Ib
subcutaneous injection once a week for 4 weeks.
Intervention: Placebo
AK120 150mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
Intervention: AK120
AK120 300mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
Intervention: AK120
AK120 450mg in phase II
subcutaneous injection every 2 weeks for 50 weeks.
Intervention: AK120
Placebo Comparator: Placebo in phase II
subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
Intervention: Placebo
AK120 150mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
Intervention: AK120
AK120 300mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
Intervention: AK120
AK120 450mg in phase II extension
subcutaneous injection every 2 weeks for 14 weeks.
Intervention: AK120
Outcomes
Primary Outcomes
Phase Ib
Time Frame: Baseline to week 12
Tmax of AK120. Assessment of Time to peak(Tmax) of AK120
Phase II
Time Frame: at week 16
Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75
Phase II Extension Study
Time Frame: 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 Outcomes
- Phase II Extension Study(Baseline to week 24)
- Phase Ib(Baseline to week 12)
- Phase II(Baseline to week 58)