Back to resultsA Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Primary Purpose
Behçet's Disease, Juvenile Psoriatic Arthritis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apremilast
Sponsored by
About this trial
This is an interventional treatment trial for Behçet's Disease focused on measuring Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla
Eligibility Criteria
Inclusion Criteria: Informed consent / assent obtained Must have completed Week 52 on treatment on core study Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) Willing to adhere to study visit schedule and protocol requirements Must have acceptable benefit/risk for continued treatment with apremilast Exclusion Criteria: Answer "yes" to any question on C-SSRS at Week 52 visit of core study Scheduled surgery or other interventions that would interrupt study participation Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose Female participants planning to become pregnant while on study through 30 days after last dose Female participants of childbearing potential with positive pregnancy test at Week 0 Known sensitivity to any products to be administered during dosing Not likely to be available to complete all protocol-required study visits
Sites / Locations
- Hospital Universitari i Politecnic La FeRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Umraniye Egitim ve Arastirma HastanesiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apremilast
Arm Description
Participants with a weight between ≥ 12 kg to < 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to < 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Columbia-Suicide Severity rating Scale (C-SSRS)
A questionnaire used to assess suicide risk.
Tanner Staging
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Change from Baseline in Body Weight
Change from Baseline in Height
Change from Baseline in Body Mass Index (BMI)
Number of Participants with Clinically Significant Changes in Vital Signs
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05767047
Brief Title
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Official Title
A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
December 29, 2032 (Anticipated)
Study Completion Date
December 29, 2032 (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 long-term safety of apremilast in participants 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behçet's Disease, Juvenile Psoriatic Arthritis
Keywords
Oral Ulcers, Behçet's Disease, Juvenile Psoriatic Arthritis, Apremilast, AMG 407, Otezla
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apremilast
Arm Type
Experimental
Arm Description
Participants with a weight between ≥ 12 kg to < 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to < 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
AMG 407, Otezla, CC-10004
Intervention Description
Oral tablets or liquid suspension
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Time Frame
Up to approximately 4 years
Title
Columbia-Suicide Severity rating Scale (C-SSRS)
Description
A questionnaire used to assess suicide risk.
Time Frame
Up to approximately 4 years
Title
Tanner Staging
Description
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Time Frame
Up to approximately 4 years
Title
Change from Baseline in Body Weight
Time Frame
Up to approximately 4 years
Title
Change from Baseline in Height
Time Frame
Up to approximately 4 years
Title
Change from Baseline in Body Mass Index (BMI)
Time Frame
Up to approximately 4 years
Title
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame
Up to approximately 4 years
Title
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time Frame
Up to approximately 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent / assent obtained
Must have completed Week 52 on treatment on core study
Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart)
Willing to adhere to study visit schedule and protocol requirements
Must have acceptable benefit/risk for continued treatment with apremilast
Exclusion Criteria:
Answer "yes" to any question on C-SSRS at Week 52 visit of core study
Scheduled surgery or other interventions that would interrupt study participation
Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
Female participants planning to become pregnant while on study through 30 days after last dose
Female participants of childbearing potential with positive pregnancy test at Week 0
Known sensitivity to any products to be administered during dosing
Not likely to be available to complete all protocol-required study visits
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
Hospital Universitari i Politecnic La Fe
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Umraniye Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34764
Country
Turkey
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 of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
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