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

NCT05565560 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: 20200346
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 29

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.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis; Apremilast; AMG 407; Moderate to Severe Plaque Psoriasis; Pediatric Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16

  Baseline, Week 16

• Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16

  Baseline, Week 16

• Percent change from baseline in total PASI score at Week 16

  Baseline, Week 16

• Percent change from baseline in affected body surface area (BSA) at Week 16

  Baseline, Week 16

• Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16

  Week 16

Study Arms (1)

Apremilast

EXPERIMENTAL

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.

Drug: Apremilast

Interventions

Apremilast DRUG

Oral tablets

Also known as: AMG 407, Otezla

Apremilast

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (29)

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Gunma University Hospital

Maebashi, Gunma, 371-8511, Japan

Location

Takagi Dermatological Clinic

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanazawa Medical University Hospital

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

Takeoka Dermatology Clinic

Marugame-shi, Kagawa-ken, 763-0074, Japan

Location

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Saruwatari Dermatology Clinic

Kagoshima, Kagoshima-ken, 890-0046, Japan

Location

Tokai University Hospital

Isehara-shi, Kanagawa, 259-1193, Japan

Location

St Marianna University Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Shinshu University Hospital

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

University of the Ryukyus Hospital

Ginowan-shi, Okinawa, 901-2725, Japan

Location

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

Location

Nippon Life Hospital

Osaka, Osaka, 550-0006, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Sugai Dermatology Park Side Clinic

Utsunomiya, Tochigi, 321-0954, Japan

Location

St Lukes International Hospital

Chuo-ku, Tokyo, 104-8560, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Mita Dermatology Clinic

Minato-ku, Tokyo, 108-0014, Japan

Location

Seibo International Catholic Hospital

Shinjuku-ku, Tokyo, 161-8521, Japan

Location

Tokyo Medical University Hospital

Shinjyuku-ku, 160-0023, Japan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

apremilast

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 4, 2022
• Study Start: January 25, 2023
• Primary Completion: November 20, 2025
• Study Completion (Estimated): September 6, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

JP (29)