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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Biological: AK111/Placebo

• Registration Number: NCT05096364
• Lead Sponsor: Akeso

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.

Study Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-27
• Primary Completion: 2023-02-03
• Study Completion: 2023-02-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK111 Regimen 2	AK111/Placebo	AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks
AK111 Regimen 1	AK111/Placebo	AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks
Placebo to AK111	AK111/Placebo	Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12
AK111 Regimen 3	AK111/Placebo	AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks
AK111 Regimen 4	AK111/Placebo	AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

AkesoBio Investigative Site 1012; 🇨🇳 Chengde, Hebei, China

AkesoBio Investigative Site 1008; 🇨🇳 Changsha, Hunan, China

AkesoBio Investigative Site 1007; 🇨🇳 Guangzhou, Guangdong, China

AkesoBio Investigative Site 1010; 🇨🇳 Shanghai, Shanghai, China

AkesoBio Investigative Site 1018; 🇨🇳 Ha'erbin, Heilongjiang, China

AkesoBio Investigative Site 1009; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1016; 🇨🇳 Beijing, Beijing, China

AkesoBio Investigative Site 1011; 🇨🇳 Bengbu, Anhui, China

AkesoBio Investigative Site 1013; 🇨🇳 Yancheng, Jiangsu, China

AkesoBio Investigative Site 1003; 🇨🇳 Guangzhou, Guangdong, China

AkesoBio Investigative Site 1001; 🇨🇳 Shanghai, Shanghai, China

AkesoBio Investigative Site 1002; 🇨🇳 Hanzhou, Zhejiang, China

AkesoBio Investigative Site 1006; 🇨🇳 Ningbo, Zhejiang, China