Fact CheckerSign in

NCT05565560CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
21 (actual)
First submitted
20 Sept 2022
Start date
25 Jan 2023
Primary completion date
20 Nov 2025
Lead sponsor
Amgen
Diseases
Psoriasis
NCT number
NCT05565560

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 21
  • From 25 Jan 2023 to the primary completion date, 20 Nov 2025
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Psoriasis flare or rebound within 4 weeks prior to screening
  • 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

Other illness

  • 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

Other

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

Who the study is looking for

  • 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

Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St Lukes International Hospital
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Fukuoka University Hospital
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Fukushima Medical University Hospital
Coordinator of this site? Confirm its status
FukushimaJapanUnknown status
Gifu University Hospital
Coordinator of this site? Confirm its status
GifuJapanUnknown status
University of the Ryukyus Hospital
Coordinator of this site? Confirm its status
Ginowan-shiJapanUnknown status
Kansai Medical University Hospital
Coordinator of this site? Confirm its status
Hirakata-shiJapanUnknown status
Tokai University Hospital
Coordinator of this site? Confirm its status
Isehara-ShiJapanUnknown status
Saruwatari Dermatology Clinic
Coordinator of this site? Confirm its status
KagoshimaJapanUnknown status
Kanazawa Medical University Hospital
Coordinator of this site? Confirm its status
Kahoku-gunJapanUnknown status
St. Marianna University Hospital
Coordinator of this site? Confirm its status
Kawasaki-shiJapanUnknown status
Hospital of the University of Occupational and Environmental Health, Japan
Coordinator of this site? Confirm its status
Kitakyushu-shiJapanUnknown status
Kurume University Hospital
Coordinator of this site? Confirm its status
Kurume-shiJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
Gunma University Hospital
Coordinator of this site? Confirm its status
MaebashiJapanUnknown status
Takeoka Dermatology Clinic
Coordinator of this site? Confirm its status
Marugame-shiJapanUnknown status
Shinshu University Hospital
Coordinator of this site? Confirm its status
Matsumoto-shiJapanUnknown status
Mita Dermatology Clinic
Coordinator of this site? Confirm its status
Minato-kuJapanUnknown status
Nagasaki University Hospital
Coordinator of this site? Confirm its status
NagasakiJapanUnknown status
Nagoya City University Hospital
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Takagi Dermatological Clinic
Coordinator of this site? Confirm its status
Obihiro ShiJapanUnknown status
Nippon Life Hospital
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Kindai University Hospital
Coordinator of this site? Confirm its status
Osakasayama-ShiJapanUnknown status
Hokkaido University Hospital
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Dokkyo Medical University Hospital
Coordinator of this site? Confirm its status
Shimotsuga-gunJapanUnknown status
Seibo International Catholic Hospital
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Tokyo Medical University Hospital
Coordinator of this site? Confirm its status
Shinjyuku-kuJapanUnknown status
Teikyo University Hospital
Coordinator of this site? Confirm its status
tabashi CityJapanUnknown status
Takamatsu Red Cross Hospital
Coordinator of this site? Confirm its status
TakamatsuJapanUnknown status
Sugai Dermatology Park Side Clinic
Coordinator of this site? Confirm its status
UtsunomiyaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.