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

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ClinicalTrials.gov Identifier: NCT01815723
Recruitment Status : Withdrawn
First Posted : March 21, 2013
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Forward-Pharma GmbH

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: FP187 Drug: Dimethyl fumarate Drug: FP187 placebo Drug: Fumaderm® placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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

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




Primary Outcome Measures :
  1. 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 ]
  2. Responder rate of Static Physician's Global Assessment (sPGA) [ Time Frame: after 20 weeks of treatment ]
    Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815723


Locations
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Canada, Ontario
Probity Medical Research
Waterloo, Ontario, Canada, N2J 1C4
Sponsors and Collaborators
Forward-Pharma GmbH
Investigators
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Principal Investigator: Kim A. Papp, MD Probity Medical Research

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Responsible Party: Forward-Pharma GmbH
ClinicalTrials.gov Identifier: NCT01815723     History of Changes
Other Study ID Numbers: FP187-301
2012-005685-35 ( EudraCT Number )
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Forward-Pharma GmbH:
Psoriasis
Dimethyl fumarate
Fumaderm®

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs