Proof-of-concept Study of Forward Pharma (FP)187 in Patients With Mild/Moderate Psoriatic Arthritis

The purpose of this study is to investigate, whether FP187 is effective in the treatment of mild to moderate psoriatic arthritis.

The study is randomised, double blind, placebo-controlled proof-of-concept trial to investigate the efficacy and safety of FP187 compared to placebo over 24 weeks of treatment in patients with mild to moderate psoriatic arthritis (PsA). The daily dose levels in the FP187 arm will be 500 mg. After completion of the double blind treatment of 24 weeks, all patients irrespective of their treatment arm will be switched to an additional 24 week open-label treatment phase with 500 mg / day FP187. Patient who do not complete the 24 week double blind part of the study as scheduled will not be eligible for participation in the open-label part.

Eligibility Criteria:
Inclusion Criteria:

* documented clinical diagnosis of mild to moderate psoriatic arthritis of at least 3 months
* active psoriatic arthritis with at least 2 tender and 2 swollen joints
* signed informed consent
* willingness and ability to comply with study procedures
* besides psoriatic arthritis, patient must be in good general health in the opinion of the investigator, as determined by medical history, physical examination, vital signs, electrocardiography and clinical laboratory parameters
* if patients are using methotrexate, they should be on a stable dosis of not more the 20mg per week for at least 90 days prior to study entrance and should present no serious toxic side effects attributable to methotrexate
* female of childbearing age must be either surgically sterile or use a highly effective medically accepted contraceptive method

Exclusion Criteria:

* female patients who are pregnant of breast-feeding or planning to become pregnant during the entire trial period
* male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period
* known allergy to any of the constituents of the products being tested
* known immunosuppressive diseases (e.g. HIV, AIDS)
* known history of latent or active granulomatous infection including tuberculosis, histoplasmosis or coccidioidomycosis
* presence of another inflammatory disease including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematous or Lyme disease
* presence of chronic widespread pain syndrome
* patients with pustular forms of psoriasis, erythrodermic or guttate psoriasis
* patients with another non-psoriatic arthropathy (e.g. osteoarthritis)
* presence of another serious or progressive disease including skin malignancy
* presence or history of any malignancy (except for basal cell carcinoma, squamous cell carcinoma in situ of the skin treated with no evidence of recurrence within 5 years, or cervix cancer in situ treated with no evidence of recurrence.)
* use at any time of an biological Disease Modifying Antirheumatic Drug (bDMARD) such as etanercept, adalimumab, golimumab, certolizumab pegol or infliximab
* corticosteroid injections within 12 weeks
* use of any dimethyl fumarate (DMF) containing product within 12 weeks
* use of any retinoid treatments, other immunosuppressive treatments, cytostatics or drugs with known harmful effects on the kidneys within the last 3 months
* use of cyclosporine, corticosteroids or psoralen + UVA (PUVA) treatment within 4 weeks
* ongoing stomach or intestinal problems (e.g. gastritis or peptic ulcer)
* Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 2x upper normal normal limit (UNL) or Gamma Glutamyl Transferase (gamma-GT) results \>2.5 UNL
* estimated creatinine clearance (Cockcroft-Gault) \< 60ml/min
* leucopenia (leucocyte count \< 3.5/nl), eosinophilia (\>750 / micro l) or lymphocytopenia (\<1.02 / nl)
* protein detected by urine stick test
* participation in another clinical trial during the last 2 months or participation in a trial with another psoriatic arthritis treatment within 6 months