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To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis

Study Purpose

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female subjects aged ≥18 years old. 2. Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis. 3. At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3. 4. Suitable for systematic therapy assessed by investigators. 5. Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06061471
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Akeso
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Skin Diseases
Additional Details

This is a randomized, double-blind phase II 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 regimen 1 or regimen 2 subcutaneous injection and follow up to week 32.

Arms & Interventions

Arms

Experimental: Experimental: AK111 regimen 1

Experimental: Experimental: AK111 regimen 2

Interventions

Drug: - AK111

AK111 regimen 1-subcutaneous injection,until week 24.

Drug: - AK111

AK111 regimen 2-subcutaneous injection,until week 24.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bengbu, Anhui, China

Status

Recruiting

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui,

Wuhu, Anhui, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui,

Chengde, Hebei, China

Status

Not yet recruiting

Address

Affiliated Hospital of Chengde Medical University

Chengde, Hebei,

Nanyang, Henan, China

Status

Not yet recruiting

Address

Nanyang First People's hospital national third class a hospital

Nanyang, Henan,

Yichang central People's hospital, Yichang, Hubei, China

Status

Not yet recruiting

Address

Yichang central People's hospital

Yichang, Hubei,

Changsha, Hunan, China

Status

Not yet recruiting

Address

The Third Xiangya Hospital of Central South University

Changsha, Hunan,

Xuzhou, Jiangsu, China

Status

Not yet recruiting

Address

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu,

Dermatology hospital of Jiangxi province, Nanchang, Jiangxi, China

Status

Not yet recruiting

Address

Dermatology hospital of Jiangxi province

Nanchang, Jiangxi,

Tianjin, Tianjin, China

Status

Not yet recruiting

Address

Tianjin academy of traditional Chinese medicine affiliated hospital

Tianjin, Tianjin,

Hangzhou First People's hospital, Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

Hangzhou First People's hospital

Hangzhou, Zhejiang,

The first hospital of Jiaxing, Jiaxing, Zhejiang, China

Status

Not yet recruiting

Address

The first hospital of Jiaxing

Jiaxing, Zhejiang,

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