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

NCT06066125 | Completed Phase 3

• 1 other identifier: AK111-301
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 34

Brief Summary

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.

Conditions

Psoriasis; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

AK111 regimen 1

EXPERIMENTAL

Drug: AK111

AK111 regimen 2

EXPERIMENTAL

Drug: AK111

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AK111 DRUG

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.

AK111 regimen 1

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥18 years old.
• Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.
• At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
• Suitable for systematic therapy assessed by investigators.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akeso: lead

Study Sites (34)

The first affiliated hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

The first affiliated hospital of wannan medical college

Wannan, Anhui, China

Location

Affiliated hospital of Chongqing Three Gorges Medical College

Chongqing, Chongqing Municipality, China

Location

Chongqing traditional Chinese medicine hospital (Daomenkou branch)

Chongqing, Chongqing Municipality, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Shenzhen People's hospital

Shenzhen, Guangdong, China

Location

The first affiliated hospital of Hainan Medical university

Haikou, Hainan, China

Location

Nanyang First People's hospital national third class a hospital

Nanyang, Henan, China

Location

Renmin hospital of Wuhan University Hubei general hospital

Wuhan, Hubei, China

Location

Yichang central People's hospital

Yichang, Hubei, China

Location

The third Xiangya hospital of Central South University

Changsha, Hunan, China

Location

The frist People's hospital of Lianyungang

Lianyungang, Jiangsu, China

Location

Dermatology Hospital of China Union Medical University

Nanjing, Jiangsu, China

Location

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Yancheng No.1 People's hospital

Yancheng, Jiangsu, China

Location

Dermatology hospital of Jiangxi province

Nanchang, Jiangxi, China

Location

The second hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Tangdu hospital of the Fourth Military Medical University

Tanggu, Shanxi, China

Location

West China school of medicine, West China hospital of Sichuan University

Chengdu, Sichuan, China

Location

Tianjin academy of traditional Chinese medicine affiliated hospita

Tianjin, Tianjin Municipality, China

Location

Tianjin Medical University general hospital

Tianjin, Tianjin Municipality, China

Location

Hangzhou first People's hospital

Hangzhou, Zhejiang, China

Location

The first hospital of Jiaxing

Jiaxing, Zhejiang, China

Location

Ningbo Huamei hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Location

The first affiliated hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Beijing friendship hospital, Capital Medical University

Beijing, China

Location

Peking University third hospital

Beijing, China

Location

Guangdong provincial people's hospital

Guangdong, China

Location

Affiliated hospital of Chengde Medical University

Hebei, China

Location

The second affiliated hospital of Harbin Medical University

Heilongjiang, China

Location

Xiangya hospital Central South University

Hunan, China

Location

Huashan hospital, Fudan University

Shanghai, China

Location

Shanghai skin disease hospital

Shanghai, China

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: March 31, 2023
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (34)