PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:September 30, 2010
End Date:February 9, 2017

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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion

The purpose of this study is to determine whether apremilast is safe and effective in the
treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and
swollen joints, pain, physical function) in treated patients.

Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis
patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in
psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and
endothelial cells, and inflammatory cells attracted to the synovium by cytokines and
chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory
pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore,
apremilast has the potential to be effective in the treatment of PsA.

Inclusion Criteria:

- Males or females, aged ≥ 18 years at time of consent.

- Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.

- Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at
time of screening.

- Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

- May not have axial involvement alone

- Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine

- Have ≥ 3 swollen AND ≥ 3 tender joints.

- Males & Females must use contraception

- Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.

- Have at least one ≥2 cm psoriasis lesion

Exclusion Criteria:

- Pregnant or breast feeding.

- History of allergy to any component of the investigational product Hepatitis B surface
antigen and/or Hepatitis C antibody positive at screening.

- Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF)
blocker
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