Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01815723
• Other study ID #: FP187-301
• Secondary ID: 2012-005685-35
• Status: Withdrawn
• Phase: Phase 3
• First received: March 19, 2013
• Last updated: August 8, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: Forward-Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Health and Medicines AuthorityCzech Republic: State Institute for Drug ControlRussia: FSI Scientific Center of Expertise of Medical ApplicationUkraine: State Pharmacological Center - Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (?-GT) > 2.5 x ULN;

• Creatinine Clearance < 60 ml/min;

• Leucopenia, eosinophilia or lymphopenia;

• Protein in the urine test;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• FP187
500 mg FP187 daily, two tablets of 125 mg twice daily, from 125 mg daily up-titrated to full dose over a 4-week phase, total treatment phase of 20 weeks
• Dimethyl fumarate
720 mg Fumaderm® daily, two tablets of 120 mg three times daily, from 30 mg daily up-titrated to full dose over a 9-week phase, total treatment phase of 20 weeks
• FP187 placebo
FP187 matching placebo tablets in the same regimen as for FP187 arm
• Fumaderm® placebo
Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm

Locations

Country	Name	City	State
Canada	Probity Medical Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Forward-Pharma GmbH

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline		after 20 weeks of treatment	No
Primary	Responder rate of Static Physician's Global Assessment (sPGA)	Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline.	after 20 weeks of treatment	No