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

• Status: Withdrawn
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Skane University Hospital
• Treatments: Dimethyl Fumarate

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