chronic plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Skilarence
Product Name: -
Product Code: [-]
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: -
Current Sponsor code: LAS41008
Concentration unit: mg milligram(s)
Concentr
Sponsors
ALMIRALL SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent signed and dated personally 2) Male or female 3) Age = 18 years 4) Diagnosis of chronic plaque psoriasis at least 6 months prior to inclusion in the study 5) Moderate-to-severe plaque psoriasis defined by at least one of the following criterion: a. PASI = 10 b. BSA = 10 and PASI = 5 c. DLQI = 10 and PASI = 5 6) Good general health or stable medical condition that does not interfere with the conduct of the study, as decided by the Investigator based on medical history, physical examination and laboratory exams 7) documented vaccination against hepatitis B or negativity to the HBsAg, HBsAb and HBcAb tests 8) negativity to the HCV test 9) negativity to the HIV test 10) documented vaccination against TBC or negativity to the Elispot TBC test 11) indication for a systemic treatment of psoriasis 12) wash-out period of at least 4 half-lives in case of previous treatment with biological drugs with anti-psoriatic activity 13) known anamnesis for at least 6 months of other previous topical and/or systemic treatments 14) Compliance with the following washout periods of the following drugs: - Corticosteroids, Vitamin A analogues, Vitamin D analogues, Coal tar, Salicylic acid preparations (2 weeks) - Systemic treatment (Washout period) - Conventional systemic antipsoriatic drugs (methotrexate, cyclosporine, acitretin), apremilast and phototherapy (4 weeks) 15) For women of child-bearing potential: negative serum pregnancy test at screening and willingness to use highly effective contraception during the study and for the following 30 days after the end of the treatment. 16) For sexually active men with female partners of childbearing age: availability to protected relationships through condom use and availability of the partner(s) to use highly effective contraceptive methods during the study period and for the next 30 days after the end of the treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women or women planning to become pregnant 2) Diagnosis of guttate, erythrodermic or pustular psoriasis 3) Abnormal hematological values such as leukocyte count ¿ 3.000 cells/mm3 or lymphocyte count ¿ 1.000 cells/l 4) History of cancer except for non-melanoma skin cancer, in the 5 years prior to enrollment in the study 5) Significant gastrointestinal problems (e.g. peptic ulcer, diarrhea, etc.) 6) Severe renal failure, with estimated glomerular filtration rate (eGFR) less than 30 ml/min using the CKD-EPI Creatinine Equation*, or using the MDRD (Modification of Diet in Renal Diseases)**, or significant proteinuria (3+ or higher) measured with reactive strips at screening. *Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2009): eGFR = 141 x min(SCr/¿, 1)a x max(SCr /¿, 1)-1.209 x 0.993 Age x 1.018 [if female] x 1.159 [if afro-american] Abbreviations/units: eGFR (estimated glomerular filtration rate) = mL/min/1.73 m2 SCr (standardized serum creatinine) = mg/dL ¿ = 0.7 (women) or 0.9 (men) a = -0.329 (women) or -0.411 (men) Min = minimum of SCr/¿ or 1 Max = maximum of SCr/¿ or 1 Age = years ** MDRD (Modification of Diet in Renal Diseases) eGFR = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 women) × (1.212 if afro-american) Abbreviations/units: eGFR (estimated glomerular filtration rate) = mL/min/1.73 m2 SCr (standardized serum creatinine) = mg/dL Age = years 7) Abnormal hepatic enzymes: • At least three times the Upper Limit of Normal (ULN/LSN): aspartate aminotransferase/ Serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ Serum glutamic pyruvic transaminase (ALT/SGPT), gamma-glutamyl transferase (gamma-GT), alkaline phosphatase (AP) • At least two times Upper Limit of Normal (ULN/LSN): bilirubin 8) Current infectious diseases 9) History of drug or alcohol abuse 10) Known HIV-positivity, any other immunosuppressive pathology or treatment with immunosuppressive drugsnota positività ad HBV e/o HCV 11) Known positivity to HBV and / or HCV 12) active tuberculosis 13) known hypersensitivity to the components of the DMF 14) Known lactose intolerance 15) previous enrollment in this study or participation in other clinical-pharmacological studies within the previous 30 days (or 5 half-lives, depending on which interval is the longest). 16) previous treatment with anti-psoriatic biological drugs without a wash-out period of at least 4 half-lives 17) inability to meet the study requirements or the Investor's negative judgment about participation in the study..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the efficacy of dimethyl fumarate (DMF) in adults with moderate-to-severe chronic plaque psoriasis. Efficacy is expressed as the percentage of patients with a = 75% reduction from baseline of the PASI after 1 year of treatment. The second main objective is to test the new drug on the Italian population.;Secondary Objective: • To evaluate the evolution of the disease in patients treated with DMF during 52 weeks of treatment through the following assessments: - Psoriasis Area and Severity Index (PASI) - Physician’s Global Assessment (PGA) - Body Surface Area (BSA) • To evaluate the percentage of patients with a = 75% reduction from baseline of the PASI after 24 weeks of treatment. • To evaluate the quality of life of patients through the Dermatology Life Quality Index (DLQI) • To evaluate itching and patient satisfaction through the Visual Analogue Scale (VAS) • To evaluate the tolerability profile • To characterize the patients participating in the study from a demographic and clinical point of view • To gather information from patients about psoriasis medications used prior to their entry in the study (topical, systemic, phototherapy);Primary end point(s): The primary endpoint of this study is the percentage of patients with a = 75% reduction from baseline of the Psoriasis Area and Severity Index (PASI 75).;Timepoint(s) of evaluation of this end point: After 1 year of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients that achieve PASI 75 (reduction = 75% of PASI).; Percentage of patients that achieve PASI 50 (reduction = 50% of PASI) .; Percentage of patients that achieve PASI 90 (reduction = 90% of PASI); Percentage of patients that achieve PASI 100 (reduction = 100% of PASI).; Variations of PASI.; Variations of PGA score.; Variations of BSA index.; Variations of DLQI.; Percent variation from baseline score of the VAS for itching.; Variation from baseline score of the VAS for patient satisfaction.; Evaluation of tolerability profile.; Treatment exposure.; Incidence of adverse events during the treatment period identified through spontaneous communication, periodic follow-up or variations of laboratory parameters (hematology, clinical chemistry, urine analysis): - Percentage of patients with adverse events (AE) and serious adverse events (SAE). - Absolute frequency and percentage for each type of event classified by dosage. - Percentage of patients that permanently interrupted treatment with DMF.;Timepoint(s) of evaluation of this end point: At week 4, 8, 12, 36 and 48 of treatment.; At week 4, 8, 12, 36, 48 e 52 of treatment.; At week 4, 8, 12, 36, 48 e 52 of treatment.; At week 4, 8, 12, 36, 48 e 52 of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; At week 24 and 52 of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment.; During the 52 weeks of treatment. | — |
Countries
Italy
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed