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

NCT05565560

Active Not RecruitingPhase 3

Sponsor: Amgen

Conditions: Plaque Psoriasis

Interventions: Apremilast

Countries: Japan

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 overview

Sex: ALL

Age: 6 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (29)

Nagoya, Aichi-ken, Japan
Fukuoka, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Kurume-shi, Fukuoka, Japan
Fukushima, Fukushima, Japan
Gifu, Gifu, Japan
Maebashi, Gunma, Japan
Obihiro-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kahoku-gun, Ishikawa-ken, Japan
Marugame-shi, Kagawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Isehara-shi, Kanagawa, Japan
Kawasaki-shi, Kanagawa, Japan
Kyoto, Kyoto, Japan
Matsumoto-shi, Nagano, Japan
Nagasaki, Nagasaki, Japan
Ginowan-shi, Okinawa, Japan
Hirakata-shi, Osaka, Japan
Osaka, Osaka, Japan
Osakasayama-shi, Osaka, Japan
Shimotsuga-gun, Tochigi, Japan
Utsunomiya, Tochigi, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjyuku-ku, Japan