A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis

February 27, 2025 updated by: Akeso

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • AkesoBio Investigative Site 1011
    • Beijing
      • Beijing, Beijing, China
        • AkesoBio Investigative Site 1009
      • Beijing, Beijing, China
        • AkesoBio Investigative Site 1016
    • Guangdong
      • Guangzhou, Guangdong, China
        • AkesoBio Investigative Site 1003
      • Guangzhou, Guangdong, China
        • AkesoBio Investigative Site 1007
    • Hebei
      • Chengde, Hebei, China
        • AkesoBio Investigative Site 1012
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China
        • AkesoBio Investigative Site 1018
    • Hunan
      • Changsha, Hunan, China
        • AkesoBio Investigative Site 1008
    • Jiangsu
      • Yancheng, Jiangsu, China
        • AkesoBio Investigative Site 1013
    • Shanghai
      • Shanghai, Shanghai, China
        • AkesoBio Investigative Site 1001
      • Shanghai, Shanghai, China
        • AkesoBio Investigative Site 1010
    • Zhejiang
      • Hanzhou, Zhejiang, China
        • AkesoBio Investigative Site 1002
      • Ningbo, Zhejiang, China
        • AkesoBio Investigative Site 1006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Male or female, 18 to 75 years of age
  2. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months

  3. Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:

    1. Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area.
    2. Psoriasis area and severity index(PASI) ≥12.
    3. Static Physicians Global Assessment score ≥3.
  4. Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
  5. Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.

Key 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 may enter the trial after sufficient treatment according to protocol.
  3. Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
  4. History of a serious or systemic infection within 2 months before screening.
  5. History of malignancy of any organ system within the past 5 years.
  6. Inadequate washout period for prior drug therapy.
  7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor.
  8. Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AK111 Regimen 1
AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks
Biological: AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Experimental: AK111 Regimen 2
AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks
Biological: AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Experimental: AK111 Regimen 3
AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks
Biological: AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Experimental: AK111 Regimen 4
AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks
Biological: AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Placebo Comparator: Placebo to AK111
Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12
Biological: AK111/Placebo
After loading dose, investigational drug was administered subcutaneously up to 60 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12
Time Frame: At week 12
At week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects who achieve PASI 75 response or higher at week 12
Time Frame: At week 12
At week 12
Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12
Time Frame: At week 12
At week 12
Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks
Time Frame: Baseline to week 68
Baseline to week 68
AK111 concentrations in serum at different time points
Time Frame: Baseline to week 68
Baseline to week 68
Number and proportion of subjects who developed anti-drug antibodies (ADAs)
Time Frame: Baseline to week 68
Baseline to week 68
Change in serum IL-17A level (Pharmacodynamics parameter）
Time Frame: Baseline to week 68
Baseline to week 68
Adverse events (AEs)/serious adverse events (SAEs)
Time Frame: Baseline to week 68
Baseline to week 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK111-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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