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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Lukes International Hospital Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Fukushima Medical University Hospital Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| University of the Ryukyus Hospital Coordinator of this site? Confirm its status | Ginowan-shi | Japan | Unknown status |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Unknown status |
| Tokai University Hospital Coordinator of this site? Confirm its status | Isehara-Shi | Japan | Unknown status |
| Saruwatari Dermatology Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Kanazawa Medical University Hospital Coordinator of this site? Confirm its status | Kahoku-gun | Japan | Unknown status |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Unknown status |
| Hospital of the University of Occupational and Environmental Health, Japan Coordinator of this site? Confirm its status | Kitakyushu-shi | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume-shi | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Gunma University Hospital Coordinator of this site? Confirm its status | Maebashi | Japan | Unknown status |
| Takeoka Dermatology Clinic Coordinator of this site? Confirm its status | Marugame-shi | Japan | Unknown status |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto-shi | Japan | Unknown status |
| Mita Dermatology Clinic Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Takagi Dermatological Clinic Coordinator of this site? Confirm its status | Obihiro Shi | Japan | Unknown status |
| Nippon Life Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osakasayama-Shi | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuga-gun | Japan | Unknown status |
| Seibo International Catholic Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjyuku-ku | Japan | Unknown status |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Takamatsu Red Cross Hospital Coordinator of this site? Confirm its status | Takamatsu | Japan | Unknown status |
| Sugai Dermatology Park Side Clinic Coordinator of this site? Confirm its status | Utsunomiya | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.