Status:
WITHDRAWN
Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Forward-Pharma GmbH
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumad...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- clinical diagnosis of stable moderate to severe plaque psoriasis for at least 6 months;
- clinical diagnosis of plaque psoriasis with an affected body surface area of no less than 10% and least 10 on the PASI scale and on the sPGA score at least as moderate;
- Besides psoriasis, patient is in good general health
- Patients with a DLQI score of at least 10
Exclusion
- Pustular forms of psoriasis, erythrodermic or guttate psoriasis;
- Known immunosuppressive diseases;
- Presence of another serious or progressive disease including skin malignancies;
- Active skin disease;
- Use of topical medical treatment or UVB treatment during the 2 weeks preceding randomization;
- Use of systemic anti-psoriatic treatment preceding randomization: methotrexate, cyclosporine, steroids or PUVA (psoralen + UVA treatment) treatment within 4 weeks; biological treatment within 12 weeks; Stelara within 20 weeks; acitretin within 6 months;
- Treatment with Fumaderm® or other Dimethyl Fumarate containing products within 12 weeks prior randomization;
- Treatment with drugs influencing the course of psoriasis (e.g., antimalarial drugs, lithium) within 4 weeks prior to randomization;
- Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within 3 months prior to randomization;
- On-going stomach or intestinal problems;
- Aspartate transaminase (AST), Alanine transaminase (ALT) \> 2 x upper normal limit (ULN), or Gamma-glutamyltransferase (γ-GT) \> 2.5 x ULN;
- Creatinine Clearance \< 60 ml/min;
- Leucopenia, eosinophilia or lymphopenia;
- Protein in the urine test;
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01815723
Start Date
June 1 2016
End Date
June 1 2017
Last Update
August 9 2016
Active Locations (1)
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1
Probity Medical Research
Waterloo, Ontario, Canada, N2J 1C4