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

Last updated: February 5, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Psoriasis And Psoriatic Disorders

Skin Wounds

Treatment

Apremilast

Clinical Study ID

NCT05565560
20200346
  • Ages 6-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 forpsoriasis

  • Candidate for systemic therapy or phototherapy

Exclusion

Exclusion Criteria:

  • Psoriasis flare or rebound within 4 weeks prior to screening

  • Evidence of skin conditions, other than psoriasis, that would interfere withclinical assessments

  • Other than psoriasis, history of any clinically significant (as determined by theinvestigator) 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 toscreening or baseline in the study, or major psychiatric illness requiringhospitalization within 3 years prior to signing the assent and informed consent

  • Guttate, erythrodermic, or pustular psoriasis at screening and baseline

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Apremilast
Phase: 3
Study Start date:
January 25, 2023
Estimated Completion Date:
September 06, 2026

Connect with a study center

  • Nagoya City University Hospital

    Nagoya-shi, Aichi 467-8602
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka 814-0180
    Japan

    Active - Recruiting

  • Hospital of the University of Occupational and Environmental Health Japan

    Kitakyushu-shi, Fukuoka 807-8556
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Fukushima Medical University Hospital

    Fukushima-shi, Fukushima 960-1295
    Japan

    Active - Recruiting

  • Gifu University Hospital

    Gifu-shi, Gifu 501-1194
    Japan

    Active - Recruiting

  • Gunma University Hospital

    Maebashi-shi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Takagi Dermatological Clinic

    Obihiro-shi, Hokkaido 080-0013
    Japan

    Active - Recruiting

  • Takagi Dermatological Clinic Branch

    Obihiro-shi, Hokkaido 080-0013
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo-shi, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Kanazawa Medical University Hospital

    Kahoku-gun, Ishikawa 920-0293
    Japan

    Active - Recruiting

  • Takeoka Dermatology Clinic

    Marugame-shi, Kagawa 763-0074
    Japan

    Active - Recruiting

  • Takamatsu Red Cross Hospital

    Takamatsu-shi, Kagawa 760-0017
    Japan

    Active - Recruiting

  • Saruwatari Dermatology Clinic

    Kagoshima-shi, Kagoshima 890-0046
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Isehara-shi, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto-shi, Kyoto 602-8566
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto-shi, Nagano 390-8621
    Japan

    Active - Recruiting

  • Nagasaki University Hospital

    Nagasaki-shi, Nagasaki 852-8501
    Japan

    Active - Recruiting

  • University of the Ryukyus Hospital

    Ginowan-shi, Okinawa 901-2725
    Japan

    Active - Recruiting

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa 903-0215
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Nippon Life Hospital

    Osaka-shi, Osaka 550-0006
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Sugai Dermatology Park Side Clinic

    Utsunomiya-shi, Tochigi 321-0954
    Japan

    Active - Recruiting

  • St Lukes International Hospital

    Chuo-ku, Tokyo 104-8560
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Itabashi-ku, Tokyo 173-8606
    Japan

    Active - Recruiting

  • Mita Dermatology Clinic

    Minato-ku, Tokyo 108-0014
    Japan

    Active - Recruiting

  • Seibo International Catholic Hospital

    Shinjuku-ku, Tokyo 161-8521
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjyuku-ku, 160-0023
    Japan

    Active - Recruiting

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