A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

Last updated: March 1, 2023
Sponsor: Akeso
Overall Status: Completed

Phase

3

Condition

Warts

Scalp Disorders

Psoriasis And Psoriatic Disorders

Treatment

N/A

Clinical Study ID

NCT05120297
AK101-302
  • Ages > 18
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects aged ≥ 18 years.
  2. Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 monthsbefore screening.
  3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥
  4. Subjects with a history of an inadequate response, intolerable or medicallyinappropriate use of systemic therapy and/or phototherapy.
  5. Subjects who are women of childbearing potential must have a negative pregnancy testat screening and must be practicing an adequate, medically acceptable method of birthcontrol for at least 6 months after the last study drug administration.

Exclusion

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 mayenter the trial after sufficient treatment had initiated and maintained according toprotocol.
  3. Positive results of confirmatory test for hepatitis B, hepatitis C, humanimmunodeficiency virus (HIV) or syphilis.
  4. History of repeated chronic infection, had any serious infection or systemic infectionwithin 2 months before screening.
  5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.
  6. History of IL12/23 or IL-23 inhibitors therapy.
  7. Inadequate washout period of prior biological therapy.
  8. History of malignant tumour within 5 years before screening.
  9. Any medical or psychiatric condition, laboratory, or ECG parameter which, in theopinion of the Investigator would place the subject at risk, interfere withparticipation or interpretation of the study.

Study Design

Total Participants: 452
Study Start date:
November 29, 2021
Estimated Completion Date:
September 29, 2022

Study Description

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Connect with a study center

  • AkesoBio Investigative Site 1010

    Bengbu, Anhui
    China

    Site Not Available

  • AkesoBio Investigative Site 1028

    Hefei, Anhui
    China

    Site Not Available

  • AkesoBio Investigative Site 1013

    Wuhu, Anhui
    China

    Site Not Available

  • AkesoBio Investigative Site 1001

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1027

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1034

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1035

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1036

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1049

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1051

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 1041

    Chongqing, Chongqing
    China

    Site Not Available

  • AkesoBio Investigative Site 1007

    Guangzhou, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1021

    Guangzhou, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1024

    Guangzhou, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1018

    Shenzhen, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1023

    Shenzhen, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1030

    Shenzhen, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1012

    Nanning, Guangxi
    China

    Site Not Available

  • AkesoBio Investigative Site 1039

    Guiyang, Guizhou
    China

    Site Not Available

  • AkesoBio Investigative Site 1025

    Chengde, Hebei
    China

    Site Not Available

  • AkesoBio Investigative Site 1017

    Shijiazhuang, Hebei
    China

    Site Not Available

  • AkesoBio Investigative Site 1031

    Shijiazhuang, Hebei
    China

    Site Not Available

  • AkesoBio Investigative Site 1014

    Harbin, Heilongjiang
    China

    Site Not Available

  • AkesoBio Investigative Site 1033

    Nanyang, Henan
    China

    Site Not Available

  • AkesoBio Investigative Site 1045

    Zhengzhou, Henan
    China

    Site Not Available

  • AkesoBio Investigative Site 1004

    Wuhan, Hubei
    China

    Site Not Available

  • AkesoBio Investigative Site 1006

    Changsha, Hunan
    China

    Site Not Available

  • AkesoBio Investigative Site 1026

    Changsha, Hunan
    China

    Site Not Available

  • AkesoBio Investigative Site 1052

    Lianyungang, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 1029

    Nanjing, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 1009

    Xuzhou, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 1015

    Yancheng, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 1019

    Nanchang, Jiangxi
    China

    Site Not Available

  • AkesoBio Investigative Site 1020

    Nanchang, Jiangxi
    China

    Site Not Available

  • AkesoBio Investigative Site 1032

    Changchun, Jilin
    China

    Site Not Available

  • AkesoBio Investigative Site 1047

    Changchun, Jilin
    China

    Site Not Available

  • AkesoBio Investigative Site 1008

    Dalian, Liaoning
    China

    Site Not Available

  • AkesoBio Investigative Site 1048

    Shenyang, Liaoning
    China

    Site Not Available

  • AkesoBio Investigative Site 1050

    Hohhot, Neimenggu
    China

    Site Not Available

  • AkesoBio Investigative Site 1044

    Yinchuan, Ningxia
    China

    Site Not Available

  • AkesoBio Investigative Site 1038

    Jinan, Shandong
    China

    Site Not Available

  • AkesoBio Investigative Site 1042

    Jinan, Shandong
    China

    Site Not Available

  • AkesoBio Investigative Site 1043

    Qingdao, Shandong
    China

    Site Not Available

  • AkesoBio Investigative Site 1005

    Shanghai, Shanghai
    China

    Site Not Available

  • AkesoBio Investigative Site 1046

    Taiyuan, Shanxi
    China

    Site Not Available

  • AkesoBio Investigative Site 1011

    Chengdu, Sichuan
    China

    Site Not Available

  • AkesoBio Investigative Site 1016

    Suining, Sichuan
    China

    Site Not Available

  • AkesoBio Investigative Site 1040

    Tianjin, Tianjin
    China

    Site Not Available

  • AkesoBio Investigative Site 1037

    Kunming, Yunnan
    China

    Site Not Available

  • AkesoBio Investigative Site 1002

    Hangzhou, Zhejiang
    China

    Site Not Available

  • AkesoBio Investigative Site 1003

    Hangzhou, Zhejiang
    China

    Site Not Available

  • AkesoBio Investigative Site 1022

    Hangzhou, Zhejiang
    China

    Site Not Available

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