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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 17 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05565560
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amgen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	MD
Principal Investigator Affiliation	Amgen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Plaque Psoriasis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - Apremilast

Oral tablets

Contact a Trial Team

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International Sites

Nagoya City University Hospital, Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya-shi, Aichi, 467-8602

Site Contact

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