A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
NCT ID: NCT05565560
Last Updated: 2025-12-19
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE3
17 participants
INTERVENTIONAL
2023-01-25
2026-09-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Apremilast
Oral tablets
Interventions
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Apremilast
Oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, Japan
Takeoka Dermatology Clinic
Marugame-shi, Kagawa-ken, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, Japan
Saruwatari Dermatology Clinic
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Shinshu University Hospital
Matsumoto-shi, Nagano, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
University of the Ryukyus Hospital
Ginowan-shi, Okinawa, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Nippon Life Hospital
Osaka, Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Sugai Dermatology Park Side Clinic
Utsunomiya, Tochigi, Japan
St Lukes International Hospital
Chuo-ku, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Mita Dermatology Clinic
Minato-ku, Tokyo, Japan
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjyuku-ku, , Japan
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20200346
Identifier Type: -
Identifier Source: org_study_id