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Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis

NCT ID: NCT01230138

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis.

Detailed Description

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The trial tests two different dose levels and two different daily dosing schedules (twice daily (BID) and three times daily (TID))over 20 weeks of treatment. Key is effect as measured by achievement of a 75% reduction in PASI after 20 weeks and safety monitored by adverse events and safety lab.

There are 3 active arms:

1. FP-187 at a daily dose of 750mg divided in three doses (250mg TID)
2. FP-187 at a daily dose of 750mg divided in two doses (375mg BID)
3. FP-187 at a daily dose of 500mg divided in two doses (250mg BID)

and 1 placebo arm.

An additional open (flexible dosing) treatment arm has been amended to the trial

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FP187 - TID

FP187 250mg TID (total daily dose of 750mg)

Group Type EXPERIMENTAL

FP187

Intervention Type DRUG

High daily dose of 750mg administered as 250mg TID

FP187- BID

FP187 375mg BID (total daily dose of 750mg)of 750mg administered as 375mg BID

Group Type EXPERIMENTAL

FP187

Intervention Type DRUG

High daily dose of 750mg administered as 375mg BID

FP187-LD-BID

FP187 250mg BID (total daily dose of 500mg)

Group Type EXPERIMENTAL

FP187

Intervention Type DRUG

Low daily dose of 500mg FP187 administered as 250mg BID

Placebo

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Open, flexible dosing treatment arm

Open treatment using a flexible dosing schedule for 8 weeks with maximum dose of 750mg FP187 and with a total dosing of 20 weeks. All investigations following same schedule.

Group Type EXPERIMENTAL

FP187

Intervention Type DRUG

Oral tablets, up to 3 times daily for 20 weeks.

Interventions

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Placebo

Placebo tablets

Intervention Type DRUG

FP187

High daily dose of 750mg administered as 250mg TID

Intervention Type DRUG

FP187

High daily dose of 750mg administered as 375mg BID

Intervention Type DRUG

FP187

Low daily dose of 500mg FP187 administered as 250mg BID

Intervention Type DRUG

FP187

Oral tablets, up to 3 times daily for 20 weeks.

Intervention Type DRUG

Other Intervention Names

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Placebo of FP187

Eligibility Criteria

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Inclusion Criteria

* Patients of either sex at least 18 years of age
* A clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with a body surface area of no less than 10% and in total to be scoring at least 10 on the PASI scale
* The psoriasis disease have been stable for at least 6 months at randomization
* Signed and dated informed consent
* Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate \< 1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:

* Systemic contraceptive (oral, implant, injection),
* Intrauterine device (IUD) inserted for at least one month prior to study entrance
* Willingness and ability to comply with the trial procedures
* Patient is beside the psoriasis disease in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs and clinical laboratory parameters (hematology, biochemistry and urinalysis).

Exclusion Criteria

* Female patients who are pregnant or breast-feeding or planning to become pregnant up to 7 months from treatment start as well as male patients plan-ning pregnancy with their partner up to 7 months from treatment start or practise unprotected sexual relationship up to 7 months from treatment start
* Known allergy to any of the constituents of the product being tested
* Pustular forms of psoriasis, erythrodermic or guttate psoriasis
* Known immunosuppressive diseases (e.g., AIDS/HIV)
* Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome
* Active skin disease such as atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome
* Use of topical medical treatment or UVB treatment - Use of systemic anti-psoriatic treatment preceding the baseline visit Methotrexate, cyclosporine, steroids or PUVA treatment within x weeks; Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within xx weeks; Acitretin within x months; Treatment with Fumaderm® or other DMF containing products during past xx weeks prior to baseline visit; Discontinuation of previous treatment with Fumaderm® or other DMF containing products due to lack of efficacy or side effects;
* Has within the past x weeks prior to baseline visit been treated with drugs influencing the course of the psoriasis such as antimalarial drugs, beta-blockers or lithium
* Has a relevant clinical history of stomach or intestinal problems (eg gastritis or peptic ulcer within the last 10 years )
* Has liver enzyme measures (AST, ALT, Gamma-GT) higher than 2x UNL)
* Has an estimated Creatinine Clearance: \< xx ml/min
* Has leucopenia (leukocyte count \< x/mm3) or eosinophilia (count \>x/µl) or lymphopenia (count \< x/nl).
* Has protein in the urine test at screening or baseline visit
* Participation in another clinical trial during the last month preceding the baseline visit or participation in a trial with treatment of biologicals within x months prior to baseline visit
* Patients who are involved in the organisation of the clinical investigation or are in any way dependant on the investigator or sponsor
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forward-Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peder M Andersen, MD

Role: STUDY_DIRECTOR

Forward-Pharma GmbH

Locations

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Dermatological Dept., Uniklinikum, TU-Dresden

Dresden, , Germany

Site Status

SCIderm

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.forward-pharma.com

Web page of Forward Pharma

Other Identifiers

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FP187-201

Identifier Type: -

Identifier Source: org_study_id