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

NCT05767047 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: 201905312022-003024-412023-503433-21
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 7

Brief Summary

The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 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.

Conditions

Behçet's Disease; Juvenile Psoriatic Arthritis

Keywords

Oral Ulcers; Behçet's Disease; Juvenile Psoriatic Arthritis; Apremilast; AMG 407; Otezla

Outcome Measures

Primary Outcomes (8)

• Number of Participants with Adverse Events

  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)

  A questionnaire used to assess suicide risk.

  Up to approximately 4 years

• Tanner Staging

  Tanner Staging of sexual development assessment will be used to assess sexual maturity.

  Up to approximately 4 years

• Change from Baseline in Body Weight

  Up to approximately 4 years

• Change from Baseline in Height

  Up to approximately 4 years

• Change from Baseline in Body Mass Index (BMI)

  Up to approximately 4 years

• Number of Participants with Clinically Significant Changes in Vital Signs

  Up to approximately 4 years

• Number of Participants with Clinically Significant Changes in Laboratory Parameters

  Up to approximately 4 years

Study Arms (1)

Apremilast

EXPERIMENTAL

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

Interventions

Apremilast DRUG

Oral tablets or liquid suspension

Also known as: AMG 407, Otezla, CC-10004

Apremilast

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent / assent obtained
• Must have completed Week 52 on treatment on core study and must be \< 18 years of age at the time the informed consent document is signed
• Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
• Willing to adhere to study visit schedule and protocol requirements
• Must have acceptable benefit/risk for continued treatment with apremilast

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (7)

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, 54642, Greece

RECRUITING

Meir Medical Center

Kfar Saba, 4428164, Israel

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Behcet Syndrome; Arthritis, Juvenile; Oral Ulcer

Interventions

apremilast

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

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

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 14, 2023
• Study Start: March 23, 2023
• Primary Completion (Estimated): March 17, 2036
• Study Completion (Estimated): March 17, 2036
• Last Updated: December 1, 2025

Record last verified: 2025-11

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

GR (1); IL (1); ES (2); TU (3)