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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forward-Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01230138
First received: September 24, 2010
Last updated: December 9, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: Placebo
Drug: FP187
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Forward-Pharma GmbH:

Primary Outcome Measures:
  • Proportion of patients achieving PASI 75 compared to placebo [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
    Proportion of patients achieving PASI75 (a reduction in the PASI score of 75% or more)


Secondary Outcome Measures:
  • PASI 75 [ Time Frame: At week 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 252
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP187 - TID
FP187 250mg TID (total daily dose of 750mg)
Drug: FP187
High daily dose of 750mg administered as 250mg TID
Experimental: FP187- BID
FP187 375mg BID (total daily dose of 750mg)of 750mg administered as 375mg BID
Drug: FP187
High daily dose of 750mg administered as 375mg BID
Experimental: FP187-LD-BID
FP187 250mg BID (total daily dose of 500mg)
Drug: FP187
Low daily dose of 500mg FP187 administered as 250mg BID
Placebo Comparator: Placebo
Placebo treatment
Drug: Placebo
Placebo tablets
Other Name: Placebo of FP187
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.
Drug: FP187
Oral tablets, up to 3 times daily for 20 weeks.

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230138

Locations
Germany
Dermatological Dept., Uniklinikum, TU-Dresden
Dresden, Germany, 01307
SCIderm
Hamburg, Germany, 20354
Sponsors and Collaborators
Forward-Pharma GmbH
Investigators
Study Director: Peder M Andersen, MD Forward-Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Forward-Pharma GmbH
ClinicalTrials.gov Identifier: NCT01230138     History of Changes
Other Study ID Numbers: FP187-201
Study First Received: September 24, 2010
Last Updated: December 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014