A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: AK111/Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • AkesoBio Investigative Site 1011
  • Beijing
    • Beijing, Beijing, China
      • AkesoBio Investigative Site 1009
    • Beijing, Beijing, China
      • AkesoBio Investigative Site 1016
  • Guangdong
    • Guangzhou, Guangdong, China
      • AkesoBio Investigative Site 1003
    • Guangzhou, Guangdong, China
      • AkesoBio Investigative Site 1007
  • Hebei
    • Chengde, Hebei, China
      • AkesoBio Investigative Site 1012
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China
      • AkesoBio Investigative Site 1018
  • Hunan
    • Changsha, Hunan, China
      • AkesoBio Investigative Site 1008
  • Jiangsu
    • Yancheng, Jiangsu, China
      • AkesoBio Investigative Site 1013
  • Shanghai
    • Shanghai, Shanghai, China
      • AkesoBio Investigative Site 1001
    • Shanghai, Shanghai, China
      • AkesoBio Investigative Site 1010
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • AkesoBio Investigative Site 1002
    • Ningbo, Zhejiang, China
      • AkesoBio Investigative Site 1006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK111 Regimen 1; AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks	Biological: AK111/Placebo; After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Experimental: AK111 Regimen 2; AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks	Biological: AK111/Placebo; After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Experimental: AK111 Regimen 3; AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks	Biological: AK111/Placebo; After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Experimental: AK111 Regimen 4; AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks	Biological: AK111/Placebo; After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Placebo Comparator: Placebo to AK111; Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12	Biological: AK111/Placebo; After loading dose, investigational drug was administered subcutaneously up to 60 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12	At week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who achieve PASI 75 response or higher at week 12	At week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 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
AK111 concentrations in serum at different time points	Baseline to week 68
Number and proportion of subjects who developed anti-drug antibodies (ADAs)	Baseline to week 68
Change in serum IL-17A level (Pharmacodynamics parameter）	Baseline to week 68
Adverse events (AEs)/serious adverse events (SAEs)	Baseline to week 68

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: safety; efficacy; AK111
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: AK111-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No