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NCT Number: NCT05767047

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

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.

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Key information

Conditions

Behçet's Disease Arthritis Arthritis, Juvenile Autoimmune Diseases Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Immune System Diseases Joint Diseases Juvenile Psoriatic Arthritis Mouth Diseases Musculoskeletal Diseases Oral Ulcer Panuveitis Rheumatic Diseases Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital of Thessaloniki Ippokrateio, Thessaloniki, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Apremilast

Drug

Oral tablets or liquid suspension

Other names: AMG 407, Otezla, CC-10004

Primary outcomes

  1. 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.

  2. Columbia-Suicide Severity rating Scale (C-SSRS)

    Time frame: Up to approximately 4 years

    A questionnaire used to assess suicide risk.

  3. Tanner Staging

    Time frame: Up to approximately 4 years

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

  4. Change from Baseline in Body Weight

    Time frame: Up to approximately 4 years

  5. Change from Baseline in Height

    Time frame: Up to approximately 4 years

  6. Change from Baseline in Body Mass Index (BMI)

    Time frame: Up to approximately 4 years

  7. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: Up to approximately 4 years

  8. Number of Participants with Clinically Significant Changes in Laboratory Parameters

    Time frame: Up to approximately 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2036
Study completion
2036
First posted
Mar 14, 2023
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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