Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Active Juvenile Psoriatic Arthritis

Treatments: Drug: Placebo; Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT04804553

20190529

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Apremilast

Experimental group

Description:

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.

Treatment:

Drug: Apremilast

Placebo to Apremilast

Placebo Comparator group

Description:

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.

Treatment:

Drug: Apremilast

Drug: Placebo