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

Phase 3

Active, not recruiting

• Conditions: Skin Diseases; Psoriasis
• Interventions: Drug: AK111; Drug: Placebo

• Registration Number: NCT06066125
• Lead Sponsor: Akeso

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.

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 Timeline

• Study Start: 2023-03-31
• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-10-04
• Last Update Posted: 2023-10-04
• Primary Completion: 2023-12
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK111 regimen 1	AK111	-
AK111 regimen 2	AK111	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (34)

Dermatology Hospital of China Union Medical University; 🇨🇳 Nanjing, Jiangsu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The first affiliated hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

The first affiliated hospital of wannan medical college; 🇨🇳 Wannan, Anhui, China

Affiliated hospital of Chongqing Three Gorges Medical College; 🇨🇳 Chongqing, Chongqing, China

Nanyang First People's hospital national third class a hospital; 🇨🇳 Nanyang, Henan, China

Renmin hospital of Wuhan University Hubei general hospital; 🇨🇳 Wuhan, Hubei, China

Chongqing traditional Chinese medicine hospital (Daomenkou branch); 🇨🇳 Chongqing, Chongqing, China

Shenzhen People's hospital; 🇨🇳 Shenzhen, Guangdong, China

Yichang central People's hospital; 🇨🇳 Yichang, Hubei, China

The third Xiangya hospital of Central South University; 🇨🇳 Changsha, Hunan, China

The frist People's hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

The affiliated hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Yancheng No.1 People's hospital; 🇨🇳 Yancheng, Jiangsu, China

Dermatology hospital of Jiangxi province; 🇨🇳 Nanchang, Jiangxi, China

The second hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

Second hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Tangdu hospital of the Fourth Military Medical University; 🇨🇳 Tanggu, Shanxi, China

West China school of medicine, West China hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tianjin academy of traditional Chinese medicine affiliated hospita; 🇨🇳 Tianjin, Tianjin, China

Tianjin Medical University general hospital; 🇨🇳 Tianjin, Tianjin, China

Hangzhou first People's hospital; 🇨🇳 Hangzhou, Zhejiang, China

The first affiliated hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Peking University third hospital; 🇨🇳 Beijing, China

Beijing friendship hospital, Capital Medical University; 🇨🇳 Beijing, China

Guangdong provincial people's hospital; 🇨🇳 Guangdong, China

Affiliated hospital of Chengde Medical University; 🇨🇳 Hebei, China

The second affiliated hospital of Harbin Medical University; 🇨🇳 Heilongjiang, China

Xiangya hospital Central South University; 🇨🇳 Hunan, China

Huashan hospital, Fudan University; 🇨🇳 Shanghai, China

Shanghai skin disease hospital; 🇨🇳 Shanghai, China

The first affiliated hospital of Hainan Medical university; 🇨🇳 Haikou, Hainan, China

Ningbo Huamei hospital, University of Chinese Academy of Sciences; 🇨🇳 Ningbo, Zhejiang, China

The first hospital of Jiaxing; 🇨🇳 Jiaxing, Zhejiang, China