Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Study Purpose

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male or Female participants 5 to < 18 years of age at the time of randomization.

- Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration: - Arthritis and psoriasis, OR.

- Arthritis with at least 2 of the following: - Dactylitis.

- Nail pitting or onycholysis.

- Psoriasis in a first-degree relative.

- Active disease: at least 3 active joints (including distal interphalangeal joints).

- Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).

Exclusion Criteria:

- Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include: - Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age.

- Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative.

- History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart.

- Presence of systemic juvenile idiopathic arthritis (JIA).

- Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.

- Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04804553
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amgen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	MD
Principal Investigator Affiliation	Amgen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Austria, Belgium, France, Germany, Greece, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, South Africa, Spain, Turkey, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Active Juvenile Psoriatic Arthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Apremilast

Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.

Placebo Comparator: Placebo to Apremilast

Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.

Interventions

Drug: - Apremilast

Participants will receive apremilast orally.

Drug: - Placebo

Participants will receive the matching placebo orally.

Contact a Trial Team

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International Sites

Landeskrankenhaus Bregenz, Bregenz, Austria

Status

Recruiting

Address

Landeskrankenhaus Bregenz

Bregenz, , 6900

Site Contact

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