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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2024-12-11

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Psoriasis Skin Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental: AK111 regimen 1

Group Type EXPERIMENTAL

AK111

Intervention Type DRUG

AK111 regimen 1-subcutaneous injection,until week 24.

Experimental: AK111 regimen 2

Group Type EXPERIMENTAL

AK111

Intervention Type DRUG

AK111 regimen 2-subcutaneous injection,until week 24.

Interventions

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AK111

AK111 regimen 1-subcutaneous injection,until week 24.

Intervention Type DRUG

AK111

AK111 regimen 2-subcutaneous injection,until week 24.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No