A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis

July 14, 2026 updated by: Amgen

A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

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.
17

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

  • Japan
      • Shinjyuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Gifu University Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Takagi Dermatological Clinic
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Ishikawa-ken
      • Kahoku-gun, Ishikawa-ken, Japan, 920-0293
        • Kanazawa Medical University Hospital
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japan, 763-0074
        • Takeoka Dermatology Clinic
      • Takamatsu, Kagawa-ken, Japan, 760-0017
        • Takamatsu Red Cross Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0046
        • Saruwatari Dermatology Clinic
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • St Marianna University Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
    • Okinawa
      • Ginowan-shi, Okinawa, Japan, 901-2725
        • University of the Ryukyus hospital
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Osaka, Osaka, Japan, 550-0006
        • Nippon Life Hospital
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital
      • Utsunomiya, Tochigi, Japan, 321-0954
        • Sugai Dermatology Park Side Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St Lukes International Hospital
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Teikyo University Hospital
      • Minato-ku, Tokyo, Japan, 108-0014
        • Mita Dermatology Clinic
      • Shinjuku-ku, Tokyo, Japan, 161-8521
        • Seibo International Catholic Hospital

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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Japanese participants aged 6 to 17 years at screening
  • Participants must have a weight of ≥ 15 kg
  • Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening
  • Has moderate to severe plaque psoriasis at screening and baseline as defined by:
  • PASI score ≥ 12; and
  • BSA ≥ 10; and
  • sPGA ≥ 3 (moderate to severe)
  • Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis
  • Candidate for systemic therapy or phototherapy

Exclusion Criteria:

  • Psoriasis flare or rebound within 4 weeks prior to screening
  • Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments
  • Other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
  • Prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
  • Guttate, erythrodermic, or pustular psoriasis at screening and baseline

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Apremilast
Participants with a weight between ≥ 15 kg to < 50 kg will receive apremilast 20 mg twice daily (BID) tablet. Participants weighing ≥ 50 kg will receive apremilast 30 mg BID tablet.
Drug: Apremilast
Oral tablets
Other Names:
  • Otezla
  • AMG 407

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
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16
Time Frame: Week 16
Week 16

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
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Percent change from baseline in total PASI score at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Time Frame: Week 16
Week 16
Change from baseline in CDLQI score at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Number of participants with treatment-emergent adverse events
Time Frame: Approximately 52 weeks
Approximately 52 weeks
Number of participants with clinically significant changes in vital signs
Time Frame: Approximately 62 weeks
Approximately 62 weeks
Number of participants with clinically significant changes in laboratory abnormalities
Time Frame: Approximately 62 weeks
Approximately 62 weeks

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.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
January 25, 2023

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.
November 20, 2025

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.
September 3, 2026

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).
September 20, 2022

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 3, 2022

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 4, 2022

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.
July 15, 2026

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.
July 14, 2026

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.
July 1, 2026

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.
  • 20200346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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