Evaluating Apremilast for Children with Moderate to Severe Plaque Psoriasis

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

This study is testing if a medication called apremilast can help Japanese children and teens aged 6 to 17 with moderate to severe plaque psoriasis feel better and improve their skin.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Amgen (industry)
• Locations: 29 sites (Nagoya-shi, Aichi and 28 other locations)
• Trial ID: NCT05565560 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of apremilast in Japanese children and adolescents aged 6 to 17 years who have been diagnosed with moderate to severe plaque psoriasis. Participants will be evaluated based on specific criteria including PASI score, body surface area affected, and severity of the disease. The study will involve administering apremilast and monitoring its effects on the participants over a defined period. The goal is to determine how well this treatment works in this specific pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are Japanese children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis who have not responded adequately to topical therapies.

Not a fit: Patients with psoriasis flare or rebound within 4 weeks prior to screening or those with other significant health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective therapeutic option for managing moderate to severe plaque psoriasis in children.

How similar studies have performed: Other studies have shown promising results with apremilast in adult populations, but this specific pediatric application is novel.

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

Where this trial is running

Nagoya-shi, Aichi and 28 other locations

• Nagoya City University Hospital — Nagoya-shi, Aichi, Japan (RECRUITING)
• Fukuoka University Hospital — Fukuoka-shi, Fukuoka, Japan (RECRUITING)
• Hospital of the University of Occupational and Environmental Health, Japan — Kitakyushu-shi, Fukuoka, Japan (RECRUITING)
• Kurume University Hospital — Kurume-shi, Fukuoka, Japan (RECRUITING)
• Fukushima Medical University Hospital — Fukushima-shi, Fukushima, Japan (RECRUITING)
• Gifu University Hospital — Gifu-shi, Gifu, Japan (RECRUITING)
• Gunma University Hospital — Maebashi-shi, Gunma, Japan (RECRUITING)
• Takagi Dermatological Clinic — Obihiro-shi, Hokkaido, Japan (RECRUITING)
• Hokkaido University Hospital — Sapporo-shi, Hokkaido, Japan (RECRUITING)
• Kanazawa Medical University Hospital — Kahoku-gun, Ishikawa, Japan (RECRUITING)
• Takeoka Dermatology Clinic — Marugame-shi, Kagawa, Japan (RECRUITING)
• Takamatsu Red Cross Hospital — Takamatsu-shi, Kagawa, Japan (RECRUITING)
• Saruwatari Dermatology Clinic — Kagoshima-shi, Kagoshima, Japan (RECRUITING)
• Tokai University Hospital — Isehara-shi, Kanagawa, Japan (RECRUITING)
• St Marianna University Hospital — Kawasaki-shi, Kanagawa, Japan (RECRUITING)
• University Hospital Kyoto Prefectural University of Medicine — Kyoto-shi, Kyoto, Japan (RECRUITING)
• Shinshu University Hospital — Matsumoto-shi, Nagano, Japan (RECRUITING)
• Nagasaki University Hospital — Nagasaki-shi, Nagasaki, Japan (RECRUITING)
• University of the Ryukyus Hospital — Ginowan-shi, Okinawa, Japan (RECRUITING)
• Kansai Medical University Hospital — Hirakata-shi, Osaka, Japan (RECRUITING)
• Nippon Life Hospital — Osaka-shi, Osaka, Japan (RECRUITING)
• Kindai University Hospital — Osakasayama-shi, Osaka, Japan (RECRUITING)
• Dokkyo Medical University Hospital — Shimotsuga-gun, Tochigi, Japan (RECRUITING)
• Sugai Dermatology Park Side Clinic — Utsunomiya-shi, Tochigi, Japan (RECRUITING)
• St Lukes International Hospital — Chuo-ku, Tokyo, Japan (RECRUITING)
• Teikyo University Hospital — Itabashi-ku, Tokyo, Japan (RECRUITING)
• Mita Dermatology Clinic — Minato-ku, Tokyo, Japan (RECRUITING)
• Seibo International Catholic Hospital — Shinjuku-ku, Tokyo, Japan (RECRUITING)
• Tokyo Medical University Hospital — Shinjyuku-ku, Japan (RECRUITING)

Study contacts

• Study coordinator: Amgen Call Center

Conditions: Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis