A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

January 8, 2025 updated by: Akeso

A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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, multicenter phase III clinical study to evaluate the safety and efficacy of AK120 in the treatment of moderate-to-severe AD in adolescents. The total duration of the study planned is approximately 57 weeks.

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 (Estimated)

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.
198

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 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China
        • The Second Affiliated Hospital of Wannan Medical College
    • Beijing
      • Beijing, Beijing, China
        • Peking University People's Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China
        • Chongqing Traditional Chinese Medicine Hospital
    • Guangdong
      • Dongguan, Guangdong, China
        • Dongguan People's Hospital
      • Guangzhou, Guangdong, China
        • The second Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Jinan University
      • Jiangmen, Guangdong, China
        • Jiangmen Central Hospital
      • Shenzhen, Guangdong, China
        • The University of Hong Kong - Shenzhen Hospital
      • Zhuhai, Guangdong, China
        • The Third People's Hospital of Zhuhai
    • Guangxi
      • Liuzhou, Guangxi, China
        • Liuzhou Worker's Hospital
    • Hubei
      • Jinzhou, Hubei, China
        • Jinzhou Central Hospital
      • Wuhan, Hubei, China
        • Tongji Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Children's Hospital
      • Changsha, Hunan, China
        • XiangYa Hospital CentralSouth University
    • Jiangsu
      • Zhenjiang, Jiangsu, China
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Dermatology Hospital of Jiangxi Province
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Dermatology Hospital
      • Jining, Shandong, China
        • Jining First People's Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Huashan Hospital, Fudan University
      • Shanghai, Shanghai, China
        • Shanghai Skin Disease Hospital
      • Shanghai, Shanghai, China
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
    • Shanxi
      • Xi'an, Shanxi, China
        • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Provincial People's Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Jiaxing, Zhejiang, China
        • The First Hospital of Jiaxing

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subjects aged ≥12<18 years old, weight ≥ 30kg.
  • AD diagnosed at least half a year before screening.
  • Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
  • Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.

Exclusion Criteria:

  • Acute onset of AD in 4 weeks prior to enrollment.
  • Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
  • Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
  • Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
  • Received treatment with other clinical study drugs within 4 weeks or 5 halflives before randomization (whichever is longer).
  • Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

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: Double

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: AK120 600mg every two weeks (Q2W) subcutaneous injection
AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.
Drug: Placebo
placebo subcutaneous injection Q2W until week 46.
Experimental: AK120 600mg every three weeks (Q3W) subcutaneous injection
AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.
Drug: placebo
placebo subcutaneous injection Q3W until week 45.

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
Measure Description
Time Frame
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75
Time Frame: at week 18 （day 127)
At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).
at week 18 （day 127)
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
Time Frame: at week 18 （day 127)
At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).
at week 18 （day 127)

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
Measure Description
Time Frame
Percentage change in affected Body Surface Area (BSA)
Time Frame: week 0 to week 52
Percentage change in BSA from baseline.
week 0 to week 52
percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
Time Frame: week 0 to week 52
percentage change of P-NRS scores from baseline at each visit. The scale ranging from 0 to 10 ( 0=no itch; 10=worst itch imaginable).
week 0 to week 52
Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score
Time Frame: week 0 to week 52
Percentage changes in the CDLQI score compared to baseline at each visit. The total score range from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.
week 0 to week 52
Incidence of Adverse Events (AE)
Time Frame: week 0 to week 52
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
week 0 to week 52

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 (Estimated)

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.
January 23, 2025

Primary Completion (Estimated)

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.
July 10, 2027

Study Completion (Estimated)

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.
July 10, 2027

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).
January 8, 2025

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.
January 8, 2025

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.
March 25, 2025

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.
January 8, 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.
January 1, 2025

More Information

Terms related to this study

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.
  • AK120-302

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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