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NCT06061471 | COMPLETED | Psoriasis

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

Akeso

Brief Summary:

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.

Condition or disease

Psoriasis

Skin Diseases

Intervention/treatment

AK111

AK111

Phase

PHASE2

Detailed Description:

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. The study has 2 parts: first part (randomized double-blind) and second part (open).

Study Type : INTERVENTIONAL
Estimated Enrollment : 454 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-09-22
Estimated Primary Completion Date : 2024-12-11
Estimated Study Completion Date : 2024-12-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis

Location Details

NCT06061471

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Anhui

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China,

Not yet recruiting

China, Anhui

The First Affiliated Hospital of Wannan Medical College

You see, Anhui, China,

Not yet recruiting

China, Hebei

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China,

Not yet recruiting

China, Henan

Nanyang First People's hospital national third class a hospital

Nanyang, Henan, China,

Not yet recruiting

China, Hubei

Yichang central People's hospital

Yichang, Hubei, China,

Not yet recruiting

China, Hunan

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China,

Not yet recruiting

China, Jiangsu

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China,

Not yet recruiting

China, Jiangxi

Dermatology hospital of Jiangxi province

Nanchang, Jiangxi, China,

Not yet recruiting

China, Tianjin

Tianjin academy of traditional Chinese medicine affiliated hospital

Tianjin, Tianjin, China,

Not yet recruiting

China, Zhejiang

Hangzhou First People's hospital

Hangzhou, Zhejiang, China,

Not yet recruiting

China, Zhejiang

The first hospital of Jiaxing

Jiaxing, Zhejiang, China,