A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

February 14, 2024 updated by: Amgen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Thessaloniki, Greece, 54642
        • Recruiting
        • General Hospital of Thessaloniki Ippokrateio
  • Israel
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
  • Turkey
      • Istanbul, Turkey, 34764
        • Recruiting
        • Umraniye Egitim ve Arastirma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apremilast
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.
Drug: Apremilast
Oral tablets or liquid suspension
Other Names:
  • CC-10004
  • Otezla
  • AMG 407

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to approximately 4 years
Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system.
Up to approximately 4 years
Columbia-Suicide Severity rating Scale (C-SSRS)
Time Frame: Up to approximately 4 years
A questionnaire used to assess suicide risk.
Up to approximately 4 years
Tanner Staging
Time Frame: Up to approximately 4 years
Tanner Staging of sexual development assessment will be used to assess sexual maturity.
Up to approximately 4 years
Change from Baseline in Body Weight
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Change from Baseline in Height
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Change from Baseline in Body Mass Index (BMI)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2023

Primary Completion (Estimated)

December 29, 2032

Study Completion (Estimated)

December 29, 2032

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190531
  • 2022-003024-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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