PALACE 2: 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:7/15/2018
Start Date:September 27, 2010
End Date:January 25, 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

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

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) PsA at time of
screening.

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

- May not have axial involvement alone

- Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine

- Have ≥ 3 swollen AND ≥ 3 tender joints.

- Males & Females must use contraception

- Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose
oral corticosteroids allowed.

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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Tacoma, Washington 98405
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601 Elmwood Avenue
Rochester, New York 14642
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4202 E Fowler Ave
Tampa, Florida 33620
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University of South Florida The University of South Florida is a high-impact, global research university...
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Arlington Hts, Illinois 60005
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Atlanta, Georgia 30342
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Battle Creek, Michigan 49015
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Bruxelles,
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3310 Live Oak St
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Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Denver, Colorado 80230
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Fort Lauderdale, Florida 33334
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Franklin, Wisconsin 53132
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Greensboro, North Carolina 27408
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Lansing, Michigan 48910
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Seattle, Washington 98104
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