Clinical trial NCT05096364: A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: AK111
efficacy
safety
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Key Inclusion Criteria:

1. Male or female, 18 to 75 years of age
2. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
3. Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:

   1. Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
   2. Psoriasis area and severity index(PASI) ≥12.
   3. Static Physicians Global Assessment score ≥3.
4. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
5. 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.

Key Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type psoriasis.
2. History or evidence of active TB, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
3. Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
4. History of a serious or systemic infection within 2 months before screening.
5. History of malignancy of any organ system within the past 5 years.
6. Inadequate washout period for prior drug therapy.
7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
8. 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.

Primary outcomes:
measure: Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
timeFrame: At week 12
Secondary outcomes:
measure: Proportion of subjects who achieve PASI 75 response or higher at week 12
timeFrame: At week 12
measure: Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
timeFrame: At week 12
measure: Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
timeFrame: Baseline to week 68
measure: AK111 concentrations in serum at different time points
timeFrame: Baseline to week 68
measure: Number and proportion of subjects who developed anti-drug antibodies (ADAs)
timeFrame: Baseline to week 68
measure: Change in serum IL-17A level (Pharmacodynamics parameter）
timeFrame: Baseline to week 68
measure: Adverse events (AEs)/serious adverse events (SAEs)
timeFrame: Baseline to week 68
Other outcomes:
Locations:
city: Bengbu
country: China
facility: AkesoBio Investigative Site 1011
state: Anhui
city: Beijing
country: China
facility: AkesoBio Investigative Site 1009
state: Beijing
city: Beijing
country: China
facility: AkesoBio Investigative Site 1016
state: Beijing
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 1003
state: Guangdong
city: Guangzhou
country: China
facility: AkesoBio Investigative Site 1007
state: Guangdong
city: Chengde
country: China
facility: AkesoBio Investigative Site 1012
state: Hebei
city: Ha'erbin
country: China
facility: AkesoBio Investigative Site 1018
state: Heilongjiang
city: Changsha
country: China
facility: AkesoBio Investigative Site 1008
state: Hunan
city: Yancheng
country: China
facility: AkesoBio Investigative Site 1013
state: Jiangsu
city: Shanghai
country: China
facility: AkesoBio Investigative Site 1001
state: Shanghai
city: Shanghai
country: China
facility: AkesoBio Investigative Site 1010
state: Shanghai
city: Hanzhou
country: China
facility: AkesoBio Investigative Site 1002
state: Zhejiang
city: Ningbo
country: China
facility: AkesoBio Investigative Site 1006
state: Zhejiang
Study officials:
References: