Back to resultsA Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Apremilast
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis
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
Sites / Locations
- Nagoya City University HospitalRecruiting
- Fukuoka University HospitalRecruiting
- Kurume University HospitalRecruiting
- Fukushima Medical University HospitalRecruiting
- Gifu University HospitalRecruiting
- Gunma University HospitalRecruiting
- Takagi Dermatological Clinic BranchRecruiting
- Takeoka Dermatology ClinicRecruiting
- Takamatsu Red Cross HospitalRecruiting
- Saruwatari Dermatology ClinicRecruiting
- Tokai University HospitalRecruiting
- St Marianna University HospitalRecruiting
- University Hospital Kyoto Prefectural University of MedicineRecruiting
- Shinshu University HospitalRecruiting
- Nagasaki University HospitalRecruiting
- University of the Ryukyus HospitalRecruiting
- Kansai Medical University HospitalRecruiting
- Nippon Life HospitalRecruiting
- Kindai University HospitalRecruiting
- Dokkyo Medical University HospitalRecruiting
- Sugai Dermatology Park Side ClinicRecruiting
- St Lukes International HospitalRecruiting
- Teikyo University HospitalRecruiting
- Seibo International Catholic HospitalRecruiting
- Tokyo Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apremilast
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Percent change from baseline in total PASI score at Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Change from baseline in CDLQI score at Week 16
Number of participants with treatment-emergent adverse events
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05565560
Brief Title
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
November 25, 2025 (Anticipated)
Study Completion Date
September 6, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apremilast
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
AMG 407, Otezla
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
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
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Time Frame
Baseline, Week 16
Title
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Time Frame
Baseline, Week 16
Title
Percent change from baseline in total PASI score at Week 16
Time Frame
Baseline, Week 16
Title
Percent change from baseline in affected body surface area (BSA) at Week 16
Time Frame
Baseline, Week 16
Title
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Time Frame
Week 16
Title
Change from baseline in CDLQI score at Week 16
Time Frame
Baseline, Week 16
Title
Number of participants with treatment-emergent adverse events
Time Frame
Approximately 52 weeks
Title
Number of participants with clinically significant changes in vital signs
Time Frame
Approximately 62 weeks
Title
Number of participants with clinically significant changes in laboratory abnormalities
Time Frame
Approximately 62 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma University Hospital
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takagi Dermatological Clinic Branch
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takeoka Dermatology Clinic
City
Marugame-shi
State/Province
Kagawa
ZIP/Postal Code
763-0074
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takamatsu Red Cross Hospital
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saruwatari Dermatology Clinic
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-0046
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
St Marianna University Hospital
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinshu University Hospital
City
Matsumoto-shi
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of the Ryukyus Hospital
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Life Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugai Dermatology Park Side Clinic
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
321-0954
Country
Japan
Individual Site Status
Recruiting
Facility Name
St Lukes International Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teikyo University Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seibo International Catholic Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
161-8521
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Shinjyuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
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