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

Primary Purpose

Plaque Psoriasis

Status

Withdrawn

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

FP187

Dimethyl fumarate

FP187 placebo

Fumaderm® placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Dimethyl fumarate, Fumaderm®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Probity Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

FP187

Dimethyl fumarate

Placebo

Arm Description

500 mg FP187 daily (250 mg twice daily)

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

Matching FP187 and Fumaderm® placebo

Outcomes

Primary Outcome Measures

Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01815723

First Posted

March 19, 2013

Last Updated

August 8, 2016

Sponsor

Forward-Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01815723

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Withdrawn

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Forward-Pharma GmbH

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

Psoriasis, Dimethyl fumarate, Fumaderm®

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FP187

Arm Type

Experimental

Arm Description

500 mg FP187 daily (250 mg twice daily)

Arm Title

Dimethyl fumarate

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching FP187 and Fumaderm® placebo

Intervention Type

Drug

Intervention Name(s)

FP187

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dimethyl fumarate

Other Intervention Name(s)

Fumaderm®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

FP187 placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fumaderm® placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline

Time Frame

after 20 weeks of treatment

Title

Responder rate of Static Physician's Global Assessment (sPGA)

Description

Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline.

Time Frame

after 20 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim A. Papp, MD

Organizational Affiliation

Probity Medical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Probity Medical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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