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

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ClinicalTrials.gov Identifier: NCT01230138
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Forward-Pharma GmbH

Tracking Information
First Submitted Date  ICMJE September 24, 2010
First Posted Date  ICMJE October 28, 2010
Last Update Posted Date December 11, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
Proportion of patients achieving PASI 75 compared to placebo [ Time Frame: After 20 weeks of treatment ]
Proportion of patients achieving PASI75 (a reduction in the PASI score of 75% or more)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • PASI 75 [ Time Frame: At week 4, 8, 12 and 16 ]
    Proportion of patients achieving PASI75 (a reduction of the PASI score of 75% or more compared to baseline)
  • PASI 50 [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Proportion of patients who achieves PASI 50 (a reduction of the PASI score of 50% or more compared to baseline)
  • PASI 90 [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Proportion of patients achieving PASI90 (a reduction of the PASI score of 90% or more compared to baseline
  • PGA (Physicians Global Assessment) [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    On a 5-point scale from 0 (abscence or very mild disease) to 4 (very severe disease) proportion of patients being responders - defined as patients achieving either a score of 0 or 1 or a two point improvement
  • PaGA (Patients Global Assessment [ Time Frame: At week 4,8,12,16 and 20 ]
    Patients evaluation on a 5-point Likert scale 1 (very good) - 5 (very poor)based on the evaluation of: "Considering all the ways your psoriasis affects you, how have you been doing in the last 24 hours?"
  • Pruritus [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Patient evaluation of pruritus measured on a VAS (Visual Analog Scale) from 0mm (no pruritus) to 100mm (worst possible pruritus)
  • Patient rated QoL (Quality of Life) [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Patient filling in 10 questions on the DLQI QoL system with a calculated summary score and analysis of the improvement from baseline
  • Adverse events (AEs) [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Summary of incidense and severity of AEs and ADRs (Adverse Drug Reactions)/SAEs (Serious Adverse Events)/SUSARs (Suspected Unexpected Serious Adverse Reactions)
  • Safety lab test [ Time Frame: At week 20 ]
    Summary of lab parameters and clinically relevant changes over the treatment period in standard clinical chemistry tests, standard haematology tests and urin dip stick test
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
  • PASI 75 [ Time Frame: At week 4, 8, 12 and 16 ]
    Proportion of patients achieving PASI75 (a reduction of the PASI score of 75% or more compared to baseline)
  • PASI 50 [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Proportion of patients who achieves PASI 50 (a reduction of the PASI score of 50% or more compared to baseline)
  • PASI 90 [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Proportion of patients achieving PASI90 (a reduction of the PASI score of 90% or more compared to baseline
  • PGA (Physicians Global Assessment) [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    On a 5-point scale from 0 (abscence or very mild disease) to 4 (very severe disease) proportion of patients being responders - defined as patients achieving either a score of 0 or 1 or a two point improvement
  • PaGA (Patients Global Assessment [ Time Frame: At week 4,8,12,16 and 20 ]
    Patients evaluation on a 5-point Likert scale 1 (very good) - 5 (very poor)based on the evaluation of: "Considering all the ways your psoriasis affects you, how have you been doing in the last 24 hours?"
  • Pruritus [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Patient evaluation of pruritus measured on a VAS (Visual Analog Scale) from 0mm (no pruritus) to 100mm (worst possible pruritus)
  • Patient rated QoL (Quality of Life) [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Patient filling in 10 questions on the DLQI QoL system with a calculated summary score and analysis of the improvement from baseline
  • Adverse events [ Time Frame: At week 4, 8, 12, 16 and 20 ]
    Summary of incidense and severity of AEs and ADRs/SAEs/SUSARs
  • Safety lab test [ Time Frame: At week 20 ]
    Summary of lab parameters and clinically relevant changes over the treatment period in standard clinical chemistry tests, standard haematology tests and urin dip stick test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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)
Brief Summary 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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: Placebo
    Placebo tablets
    Other Name: 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.
Study Arms  ICMJE
  • Experimental: FP187 - TID
    FP187 250mg TID (total daily dose of 750mg)
    Intervention: Drug: FP187
  • Experimental: FP187- BID
    FP187 375mg BID (total daily dose of 750mg)of 750mg administered as 375mg BID
    Intervention: Drug: FP187
  • Experimental: FP187-LD-BID
    FP187 250mg BID (total daily dose of 500mg)
    Intervention: Drug: FP187
  • Placebo Comparator: Placebo
    Placebo treatment
    Intervention: Drug: Placebo
  • Experimental: 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.
    Intervention: Drug: FP187
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
252
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2010)
180
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230138
Other Study ID Numbers  ICMJE FP187-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forward-Pharma GmbH
Study Sponsor  ICMJE Forward-Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Peder M Andersen, MD Forward-Pharma GmbH
PRS Account Forward-Pharma GmbH
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP