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

Last updated: February 19, 2025
Sponsor: Akeso
Overall Status: Completed

Phase

3

Condition

Rosacea

Rash

Skin Wounds

Treatment

Placebo

AK111

Clinical Study ID

NCT06066125
AK111-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects aged ≥18 years old.

  2. Subjects diagnosed with moderate to severe plaque psoriasis with or withoutpsoriatic 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 testat screening and must be practicing an adequate, medically acceptable method ofbirth control during the study and for at least 6 months after the last study drugadministration.

Exclusion

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 thetrial after sufficient treatment had initiated and maintained according to protocol.

  4. Positive results of confirmatory test for hepatitis B, hepatitis C, humanimmunodeficiency virus (HIV) or syphilis.

  5. History of repeated chronic infection, had any serious infection or systemicinfection within 2 months before screening.

  6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory,digestive, neuropsychiatric or psychological, hematological, endocrine and othersystems 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 allergicreactions to monoclonal antibodies.

Study Design

Total Participants: 351
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 31, 2023
Estimated Completion Date:
August 19, 2024

Study 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.

Connect with a study center

  • The first affiliated hospital of Bengbu Medical College

    Bengbu, Anhui
    China

    Site Not Available

  • The first affiliated hospital of wannan medical college

    Wannan, Anhui
    China

    Site Not Available

  • Affiliated hospital of Chongqing Three Gorges Medical College

    Chongqing, Chongqing
    China

    Site Not Available

  • Chongqing traditional Chinese medicine hospital (Daomenkou branch)

    Chongqing, Chongqing
    China

    Site Not Available

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

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shenzhen People's hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • The first affiliated hospital of Hainan Medical university

    Haikou, Hainan
    China

    Site Not Available

  • Nanyang First People's hospital national third class a hospital

    Nanyang, Henan
    China

    Site Not Available

  • Renmin hospital of Wuhan University Hubei general hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Yichang central People's hospital

    Yichang, Hubei
    China

    Site Not Available

  • The third Xiangya hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The frist People's hospital of Lianyungang

    Lianyungang, Jiangsu
    China

    Site Not Available

  • Dermatology Hospital of China Union Medical University

    Nanjing, Jiangsu
    China

    Site Not Available

  • The affiliated hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Yancheng No.1 People's hospital

    Yancheng, Jiangsu
    China

    Site Not Available

  • Dermatology hospital of Jiangxi province

    Nanchang, Jiangxi
    China

    Site Not Available

  • The second hospital of Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • Tangdu hospital of the Fourth Military Medical University

    Tanggu, Shanxi
    China

    Site Not Available

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

    Chengdu, Sichuan
    China

    Site Not Available

  • Tianjin Medical University general hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin academy of traditional Chinese medicine affiliated hospita

    Tianjin, Tianjin
    China

    Site Not Available

  • Hangzhou first People's hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The first hospital of Jiaxing

    Jiaxing, Zhejiang
    China

    Site Not Available

  • Ningbo Huamei hospital, University of Chinese Academy of Sciences

    Ningbo, Zhejiang
    China

    Site Not Available

  • The first affiliated hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Beijing friendship hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Peking University third hospital

    Beijing,
    China

    Site Not Available

  • Guangdong provincial people's hospital

    Guangdong,
    China

    Site Not Available

  • Affiliated hospital of Chengde Medical University

    Hebei,
    China

    Site Not Available

  • The second affiliated hospital of Harbin Medical University

    Heilongjiang,
    China

    Site Not Available

  • Xiangya hospital Central South University

    Hunan,
    China

    Site Not Available

  • Huashan hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • Shanghai skin disease hospital

    Shanghai,
    China

    Site Not Available

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