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A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT06066125•Akeso

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (34)

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 Municipality, China

Chongqing traditional Chinese medicine hospital (Daomenkou branch)

Chongqing, Chongqing Municipality, China

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

Guangzhou, Guangdong, China

Shenzhen People's hospital

Shenzhen, Guangdong, China

The first affiliated hospital of Hainan Medical university

Haikou, Hainan, 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

Yichang central People's hospital

Yichang, Hubei, China

Key Dates

Start Date

March 31, 2023

Primary Completion Date

August 19, 2024

Completion Date

August 19, 2024

Last Updated

February 20, 2025

Enrollment

351

ACTUAL participants

Conditions

PsoriasisSkin Diseases

Interventions

AK111

DRUG

AK111

DRUG

Placebo

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments