Trial | NCT01230138  Report issue

Title

Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis
A Randomised, Double Blind, Placebo Controlled Efficacy and Safety Trial of Different Doses/Dose Regimens of FP187 Compared to Placebo in Moderate to Severe Plaque Psoriasis (Pivotal Registration Study)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    252
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.
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:

FP-187 at a daily dose of 750mg divided in three doses (250mg TID)
FP-187 at a daily dose of 750mg divided in two doses (375mg BID)
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
Study Started
Sep 30
2010
Primary Completion
Jan 31
2012
Study Completion
May 31
2012
Last Update
Dec 11
2012
Estimate

Drug Placebo

Placebo tablets

  • Other names: Placebo of FP187

Drug FP187

High daily dose of 750mg administered as 250mg TID

Drug FP187

High daily dose of 750mg administered as 375mg BID

Drug FP187

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

Drug FP187

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

FP187 - TID Experimental

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

FP187- BID Experimental

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

FP187-LD-BID Experimental

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

Placebo Placebo Comparator

Placebo treatment

Open, flexible dosing treatment arm Experimental

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.

Criteria 

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
No Results Posted