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.

Overview

No summary available.

Registry

who.int

Start Date

June 9, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients will be entered into this trial only if they meet all of the following 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 score 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 randomisation
•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:
•oSystemic contraceptive (oral, implant, injection),
•oIntrauterine 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 (systolic and diastolic blood pressure \[upper limit 145/90] pulse rate \[between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (hematology, biochemistry and urinalysis). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.

•Patients will not be enrolled if they meet any of the following 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 planning 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 during the 2 weeks preceding the baseline visit (Day \-5\),
•Use of systemic anti\-psoriatic treatment preceding the baseline visit (Day \-5\):
•.1Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks,