A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- AK111/Placebo
- Conditions
- Psoriasis
- Sponsor
- Akeso
- Enrollment
- 251
- Locations
- 13
- Primary Endpoint
- Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, 18 to 75 years of age
- •Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
- •Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
- •Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
- •Psoriasis area and severity index(PASI) ≥
- •Static Physicians Global Assessment score ≥
- •Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
- •Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.
Exclusion Criteria
- •Forms of psoriasis other than chronic plaque-type psoriasis.
- •History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
- •Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
- •History of a serious or systemic infection within 2 months before screening.
- •History of malignancy of any organ system within the past 5 years.
- •Inadequate washout period for prior drug therapy.
- •Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
- •Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
Arms & Interventions
AK111 Regimen 2
AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks
Intervention: AK111/Placebo
AK111 Regimen 1
AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks
Intervention: AK111/Placebo
AK111 Regimen 3
AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks
Intervention: AK111/Placebo
AK111 Regimen 4
AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks
Intervention: AK111/Placebo
Placebo to AK111
Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12
Intervention: AK111/Placebo
Outcomes
Primary Outcomes
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time Frame: At week 12
Secondary Outcomes
- Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12(At week 12)
- Change in serum IL-17A level (Pharmacodynamics parameter）(Baseline to week 68)
- Number and proportion of subjects who developed anti-drug antibodies (ADAs)(Baseline to week 68)
- Proportion of subjects who achieve PASI 75 response or higher at week 12(At week 12)
- Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks(Baseline to week 68)
- Adverse events (AEs)/serious adverse events (SAEs)(Baseline to week 68)
- AK111 concentrations in serum at different time points(Baseline to week 68)