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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565560
• Other study ID #: 20200346
• Status: Recruiting
• Phase: Phase 3
• Start date: January 25, 2023
• Est. completion date: September 6, 2026

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: September 6, 2026
• Est. primary completion date: November 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Apremilast
Oral tablets

Locations

Country	Name	City	State
Japan	St Lukes International Hospital	Chuo-ku	Tokyo
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima-shi	Fukushima
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Kansai Medical University Hospital	Hirakata-shi	Osaka
Japan	Tokai University Hospital	Isehara-shi	Kanagawa
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo
Japan	Saruwatari Dermatology Clinic	Kagoshima-shi	Kagoshima
Japan	St Marianna University Hospital	Kawasaki-shi	Kanagawa
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	Gunma University Hospital	Maebashi-shi	Gunma
Japan	Takeoka Dermatology Clinic	Marugame-shi	Kagawa
Japan	Shinshu University Hospital	Matsumoto-shi	Nagano
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	University of the Ryukyus Hospital	Nakagami-gun	Okinawa
Japan	Takagi Dermatological Clinic	Obihiro-shi	Hokkaido
Japan	Nippon Life Hospital	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama-shi	Osaka
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi
Japan	Seibo International Catholic Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjyuku-ku
Japan	Takamatsu Red Cross Hospital	Takamatsu-shi	Kagawa
Japan	Sugai Dermatology Park Side Clinic	Utsunomiya-shi	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16		Baseline, Week 16
Secondary	Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16		Baseline, Week 16
Secondary	Percent change from baseline in total PASI score at Week 16		Baseline, Week 16
Secondary	Percent change from baseline in affected body surface area (BSA) at Week 16		Baseline, Week 16
Secondary	Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16		Week 16
Secondary	Change from baseline in CDLQI score at Week 16		Baseline, Week 16
Secondary	Number of participants with treatment-emergent adverse events		Approximately 52 weeks
Secondary	Number of participants with clinically significant changes in vital signs		Approximately 62 weeks
Secondary	Number of participants with clinically significant changes in laboratory abnormalities		Approximately 62 weeks

External Links

•   AmgenTrials clinical trials website