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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: FP187; Drug: Fumaderm® placebo; Drug: Dimethyl fumarate; Drug: FP187 placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2J 1C4
      • Probity Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FP187; 500 mg FP187 daily (250 mg twice daily)	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; Drug: Fumaderm® placebo; Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm
Active Comparator: Dimethyl fumarate; 720 mg Fumaderm® daily (240 mg three times daily)	Drug: 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; Other Names: Fumaderm®; Drug: FP187 placebo; FP187 matching placebo tablets in the same regimen as for FP187 arm
Placebo Comparator: Placebo; Matching FP187 and Fumaderm® placebo	Drug: Fumaderm® placebo; Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm; Drug: FP187 placebo; FP187 matching placebo tablets in the same regimen as for FP187 arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline		after 20 weeks of treatment
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

Collaborators and Investigators

• Sponsor: Forward-Pharma GmbH
• Investigators: Principal Investigator: Kim A. Papp, MD, Probity Medical Research

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Psoriasis; Dimethyl fumarate; Fumaderm®
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: FP187-301; 2012-005685-35 (EudraCT Number)