Clinical trial NCT01815723: Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
Official title: A Randomised, Double Blind, Double Dummy, Active Comparator and Placebo Controlled Confirmative Non-inferiority Trial of FP187 Compared to Fumaderm® in Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Dimethyl fumarate
Fumaderm®
Lead sponsor: Forward-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2013-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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;

Primary outcomes:
measure: Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline
timeFrame: after 20 weeks of treatment
measure: Responder rate of Static Physician's Global Assessment (sPGA)
timeFrame: after 20 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Probity Medical Research
state: Ontario
Study officials:
affiliation: Probity Medical Research
name: Kim A. Papp, MD
role: PRINCIPAL_INVESTIGATOR
References: