Moderate Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Skilarence (30mg)
Product Name: Skilarence (30mg)
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624-49-7
Concentration unit: mg milligram(
Sponsors
Almirall Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study patients must meet all of the following inclusion criteria: • Signed and dated informed consent • Males and females = 18 years • Diagnosis of plaque psoriasis at least 6 months prior to screening visit • BSA = 5% at screening and baseline • PASI score between 5 and 10 at screening and baseline • Static Physician´s Global Assessment (sPGA) of 3 (moderate) based on a 6 point scale at screening and baseline • DLQI = 5 at screening and baseline • Wash-out period for topical treatments (= 2 weeks) and for phototherapy and other non-biologic systemic therapies (=4weeks) prior to baseline (Visit 2). • A candidate to receive systemic treatment for psoriasis based on physician clinical judgement • Women of child-bearing potential must have a negative serum pregnancy test at Visit 1 (Screening) and a negative urine pregnancy test at Visit 2 (Baseline) • Females of child-bearing potential must be willing to use highly effective methods of birth control during the study period. Additionally they must agree to have pregnancy tests while on Skilarence®. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intrauterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for 12 months or more. • No previous use of biologic treatments for psoriasis or psoriatic arthropathy Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: In order to participate in the study patients must not meet any of the following exclusion criteria: • Females who are pregnant, breast feeding, refuse to use birth control methods or who wish to become pregnant during the study period • Diagnosis of other psoriasis clinical subtypes such as guttate, erythrodermic or pustular psoriasis • Diagnosis of active psoriatic arthropathy • Diagnosis of Fanconi syndrome • Baseline white blood cell count 3x the upper limit of the normal range (ULN) should be excluded. If bilirubin is >2x ULN, then an AST, ALT or ALP of >2x ULN is exclusionary. Elevated gamma-GT (GGT) values exceeding >3x ULN are allowed but these GGT cases will be carefully assessed alongside other clinical and laboratory data by the investigator • History of severe gastrointestinal problems • History of active infectious disease • Known human immunodeficiency virus (HIV)-positive status or suffering from any other immunosuppressive disease • Known to be hypersensitive to any of the ingredients of Skilarence®. • Previously enrolled in any study or participating in any other drug investigational trial within the 30 days (or five half-lives of the investigational product studied, whichever is longer) prior to enrolment. • History of major psychiatric illness • Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess the efficacy of Skilarence® (Dimethyl Fumarate) at week 24 of treatment as measured by static Physician’s Global Assessment score (sPGA) multiplied by percentage Body Surface Area (BSA). ;Secondary Objective: The secondary objectives of this study are to assess impact on: oDermatology Life Quality Index (DLQI) oPsoriasis Area and Severity Index (PASI) oStatic Physician´s Global Assessment (sPGA) oBody Surface Area (BSA) oPatient satisfaction with Skilarence® treatment efficacy on psoriasis in patients treated with Skilarence® (Dimethyl Fumarate) for 24 weeks, compared to baseline •To describe the safety profile in moderate patients treated with Skilarence® (Dimethyl Fumarate) over 24 weeks ;Primary end point(s): The primary outcome measure for this study is defined as; The mean percentage change from baseline in the product of sPGA and BSA (%) (sPGA*BSA) at week 24 of treatment. ;Timepoint(s) of evaluation of this end point: Week 24 of treatment with Skilarence | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of patients with PASI 75 (=75% reduction from baseline) at weeks 12, 16 and 24 • Percentage of patients with PASI 50 (=50% reduction from baseline) at weeks 12, 16 and 24 • Percentage change from baseline in PASI score at weeks 12, 16 and 24 • Percentage of patients that achieve PASI score of <1, <3 and <5 at week 24 • Absolute PASI scores at weeks 12, 16 and 24 • Percentage change from baseline in BSA at weeks 12, 16 and 24 • Percentage change from baseline in DLQI at weeks 12, 16 and 24 • Percentage change from baseline in sPGA*BSA at weeks 12 and 16 • Percentage of patients achieving a score of “clear” or ”almost clear” in sPGA at weeks 12, 16 and 24. Safety Variables: • Physical examination • Vital signs • Serum chemistry, haematology, urinalysis • Adverse events ;Timepoint(s) of evaluation of this end point: Weeks, 12, 16 and 24 | — |
Countries
Denmark, Ireland, United Kingdom
Contacts
Public ContactDr Amanda Knock
Smerud Medical Research UK Limited
Outcome results
None listed