A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
- Registration Number
- NCT05565560
- Lead Sponsor
- Amgen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 33
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apremilast 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.
- Primary Outcome Measures
Name Time Method 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 Week 16
- Secondary Outcome Measures
Name Time Method Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16 Baseline, Week 16 Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16 Baseline, Week 16 Percent change from baseline in total PASI score at Week 16 Baseline, Week 16 Percent change from baseline in affected body surface area (BSA) at Week 16 Baseline, Week 16 Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16 Week 16 Change from baseline in CDLQI score at Week 16 Baseline, Week 16 Number of participants with treatment-emergent adverse events Approximately 52 weeks Number of participants with clinically significant changes in vital signs Approximately 62 weeks Number of participants with clinically significant changes in laboratory abnormalities Approximately 62 weeks
Trial Locations
- Locations (29)
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health Japan
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Mita Dermatology Clinic
🇯🇵Minato-ku, Tokyo, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Gifu University Hospital
🇯🇵Gifu-shi, Gifu, Japan
Gunma University Hospital
🇯🇵Maebashi-shi, Gunma, Japan
Takagi Dermatological Clinic
🇯🇵Obihiro-shi, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Kanazawa Medical University Hospital
🇯🇵Kahoku-gun, Ishikawa, Japan
Takeoka Dermatology Clinic
🇯🇵Marugame-shi, Kagawa, Japan
Takamatsu Red Cross Hospital
🇯🇵Takamatsu-shi, Kagawa, Japan
Saruwatari Dermatology Clinic
🇯🇵Kagoshima-shi, Kagoshima, Japan
Tokai University Hospital
🇯🇵Isehara-shi, Kanagawa, Japan
St Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
Shinshu University Hospital
🇯🇵Matsumoto-shi, Nagano, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-shi, Nagasaki, Japan
University of the Ryukyus Hospital
🇯🇵Ginowan-shi, Okinawa, Japan
Kansai Medical University Hospital
🇯🇵Hirakata-shi, Osaka, Japan
Nippon Life Hospital
🇯🇵Osaka-shi, Osaka, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-gun, Tochigi, Japan
Sugai Dermatology Park Side Clinic
🇯🇵Utsunomiya-shi, Tochigi, Japan
St Lukes International Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Seibo International Catholic Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjyuku-ku, Japan