Clinical trial NCT05565560: A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Apremilast
AMG 407
Moderate to Severe Plaque Psoriasis
Pediatric Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 33
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 for psoriasis
* Candidate for systemic therapy or phototherapy

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Week 16
Secondary outcomes:
measure: Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
timeFrame: Baseline, Week 16
measure: Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
timeFrame: Baseline, Week 16
measure: Percent change from baseline in total PASI score at Week 16
timeFrame: Baseline, Week 16
measure: Percent change from baseline in affected body surface area (BSA) at Week 16
timeFrame: Baseline, Week 16
measure: Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
timeFrame: Week 16
measure: Change from baseline in CDLQI score at Week 16
timeFrame: Baseline, Week 16
measure: Number of participants with treatment-emergent adverse events
timeFrame: Approximately 52 weeks
measure: Number of participants with clinically significant changes in vital signs
timeFrame: Approximately 62 weeks
measure: Number of participants with clinically significant changes in laboratory abnormalities
timeFrame: Approximately 62 weeks
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Obihiro-shi
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Marugame-shi
country: Japan
facility: Takeoka Dermatology Clinic
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Saruwatari Dermatology Clinic
state: Kagoshima
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: St Marianna University Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Ginowan-shi
country: Japan
facility: University of the Ryukyus Hospital
state: Okinawa
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Nippon Life Hospital
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Utsunomiya-shi
country: Japan
facility: Sugai Dermatology Park Side Clinic
state: Tochigi
city: Chuo-ku
country: Japan
facility: St Lukes International Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Mita Dermatology Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Seibo International Catholic Hospital
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Medical University Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: