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

NCT01815723 | Withdrawn Phase 3

• 2 other identifiers: FP187-3012012-005685-35
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Dimethyl fumarate; Fumaderm®

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

FP187

EXPERIMENTAL

500 mg FP187 daily (250 mg twice daily)

Drug: FP187; Drug: Fumaderm® placebo

Dimethyl fumarate

ACTIVE COMPARATOR

720 mg Fumaderm® daily (240 mg three times daily)

Drug: Dimethyl fumarate; Drug: FP187 placebo

Placebo

PLACEBO COMPARATOR

Matching FP187 and Fumaderm® placebo

Drug: FP187 placebo; Drug: Fumaderm® placebo

Interventions

FP187 DRUG

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

FP187

Dimethyl fumarate DRUG

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

Also known as: Fumaderm®

Dimethyl fumarate

FP187 placebo DRUG

FP187 matching placebo tablets in the same regimen as for FP187 arm

Dimethyl fumarate; Placebo

Fumaderm® placebo DRUG

Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm

FP187; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Forward-Pharma GmbH: lead

Study Sites (1)

Probity Medical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Kim A. Papp, MD

  Probity Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

CA (1)