A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Diseases; Psoriasis
• Intervention / Treatment: Drug: AK111; Drug: AK111; Drug: Placebo

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. Subjects will be randomized to receive AK111 or placebo subcutaneously and followed up to week 56.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Guangdong, China
    • Guangdong Provincial People's Hospital
  • Hebei, China
    • Affiliated Hospital of Chengde Medical University
  • Heilongjiang, China
    • The Second Affiliated Hospital of Harbin Medical University
  • Hunan, China
    • Xiangya Hospital Central South University
  • Shanghai, China
    • Shanghai Skin Disease Hospital
  • Shanghai, China
    • Huashan Hospital, Fudan University
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical College
    • Wannan, Anhui, China
      • The First Affiliated Hospital of Wannan Medical College
  • Chongqing
    • Chongqing, Chongqing, China
      • Affiliated Hospital of Chongqing Three Gorges Medical College
    • Chongqing, Chongqing, China
      • Chongqing traditional Chinese medicine hospital (Daomenkou branch)
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China
      • Shenzhen People's Hospital
  • Hainan
    • Haikou, Hainan, China
      • The first Affiliated Hospital of Hainan Medical University
  • Henan
    • Nanyang, Henan, China
      • Nanyang First People's hospital national third class a hospital
  • Hubei
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University Hubei General Hospital
    • Yichang, Hubei, China
      • Yichang Central People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Lianyungang, Jiangsu, China
      • The frist People's hospital of Lianyungang
    • Nanjing, Jiangsu, China
      • Dermatology Hospital of China Union Medical University
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University
    • Yancheng, Jiangsu, China
      • Yancheng No.1 People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Dermatology Hospital of Jiangxi Province
  • Liaoning
    • Dalian, Liaoning, China
      • The Second Hospital of Dalian Medical University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
    • Tanggu, Shanxi, China
      • Tangdu Hospital of the Fourth Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China School of Medicine, West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Tianjin academy of traditional Chinese medicine affiliated hospita
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
    • Jiaxing, Zhejiang, China
      • The First hospital of Jiaxing
    • Ningbo, Zhejiang, China
      • Ningbo Huamei Hospital, University of Chinese Academy of Sciences
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects aged ≥18 years old.
2. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.
3. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
4. Suitable for systematic therapy assessed by investigators.
5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last study drug administration.

Exclusion Criteria:

1. Types of psoriasis other than chronic plaque-type psoriasis.
2. Drug-induced psoriasis.
3. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
4. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
5. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization.
7. History of malignant tumour within 5 years before screening.
8. Previous or current autoimmune diseases.
9. Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo- subcutaneous injection at week 0,1,2, 3, 4 and week 8. AK111 regimen 2-subcutaneous injection every 4 weeks from week 12 to week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Experimental: AK111 regimen 1	Drug: AK111; AK111 regimen 1- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.; Drug: AK111; AK111 regimen 2- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Experimental: AK111 regimen 2	Drug: AK111; AK111 regimen 1- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.; Drug: AK111; AK111 regimen 2- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of subjects who achieved at least 75% reduction in psoriasis area and severity index(PASI) score from baseline (PASI 75) and the percentage of subjects who achieved static physician global assessment(sPGA) 0/1 at week 12.	PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving >= 50%, >= 75% or >= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.	at week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12.	at week 12
The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52.	at week 52

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Psoriasis; Skin Diseases
• Other Study ID Numbers: AK111-301

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