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Plaque PsoriasisPhase 3NCT01815723

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

A Phase 3 study testing FP187 and Dimethyl fumarate in people with Plaque Psoriasis, run by Forward-Pharma GmbH at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
FP187 and Dimethyl fumarate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteCanada
Study dates
Jun 2016to Jun 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 14Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Probity Medical Research

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

About this study

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

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.

Being tested
FP187, Dimethyl fumarate, FP187 placebo, Fumaderm® placebo
Keywords
Psoriasis, Dimethyl fumarate, Fumaderm®
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FP187Drug

    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 fumarateDrug

    Also called Fumaderm®

    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 placeboDrug

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

  • Fumaderm® placeboDrug

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

Study groups in NCT01815723
Study groupRoleWhat they receive
FP187Experimental500 mg FP187 daily (250 mg twice daily)
Receives: Drug: FP187; Drug: Fumaderm® placebo
Dimethyl fumarateActive comparator720 mg Fumaderm® daily (240 mg three times daily)
Receives: Drug: Dimethyl fumarate; Drug: FP187 placebo
PlaceboPlacebo comparatorMatching FP187 and Fumaderm® placebo
Receives: Drug: FP187 placebo; Drug: Fumaderm® placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: after 20 weeks of treatment

  2. 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.

    Measured: after 20 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2013 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01815723
Sponsor's protocol ID
FP187-301
Other IDs
2012-005685-35
Status last verified
Aug 2016
First submitted
19 Mar 2013
Last updated
9 Aug 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FP187 and Dimethyl fumarate in people with Plaque Psoriasis, run by Forward-Pharma GmbH at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01815723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.

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