Moderate-severe chronic plaque psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Skilarence
Pharmaceutical Form: Tablet
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Signed and personally dated written informed consent (2) Male / female (3) Aged 18 years or older (4) With a diagnosis of chronic plaque psoriasis for at least 6 months before enrolment in the study (5) With the severity of psoriasis defined as moderate to severe, as reflected in meeting one of the following criteria: - PASI = 10 - BSA = 10 + PASI = 5 - DLQI = 10 + PASI = 5 (6) With general good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the investigator based upon results of medical history, laboratory results and physical examination (7) Candidate for systemic treatment. (8) With a complete record of at least 6 months of other previous topical and systemic treatments, if any. (9) Adhering to the following wash-out periods: Topical treatment: Wash-out Period: 2 weeks: Corticosteroids,Vitamin A analogues, Vitamin D analoguess, Tar, Salicylic acid preparations. Systemic treatment: Wash-out Period: 4 weeks: Conventional systemic antipsoriatic drugs (methotrexate, cyclosporine, acitretin), apremilast and phototherapy. (10) For females of child-bearing potential: a negative serum pregnancy test at screening and willing to use highly effective methods of birth control during the study period. 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. For females: pregnant or willing to be pregnant or breastfeeding 2. With a diagnosis of guttate, erythrodermic or pustular psoriasis 3. With a haematological abnormality as white blood cell (WBC) count 3,0 x 10^9/l or lymphocyte count 3x the upper limit of the normal range (ULN): aspartate amino transferase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine amino transferase (ALT; serum glutamic pyruvic transaminase [SGPT]), gamma-glutamyl-transferase (gamma-GT), alkaline phosphatase (ALP) b) if bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary 8. With active infectious disease 9. With a history of alcohol or drug abuse 10. Known suffering from any other immunosuppressive disease or treated with any immunosuppressive drug 11. Known to be hypersensitive to ingredients of DMF 12. Known to be intolerant to lactose 13. Previously enrolled in this study or participating in any drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment. 14. Previously treated with biologic drug with antipsoriatic activity 15. Unable to comply with the requirements of the study or who in the opinion of the investigator should not have participated in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of dimethylfumarate (DMF) at treatment week 24 by reducing at least 75% in the Psoriasis Area and Severity Index (PASI75) compared to baseline in adults with moderate to severe chronic plaque psoriasis .;Secondary Objective: Progress of PASI75, PASI50, PASI90, PASI100 in the treatment with DMF in the 52 weeks. Progress of the absolute value of the PASI in the treatment with DMF in the 52 weeks. Progress of the Physician's Global Assessment index in patients treated with DMF in the 52 weeks. Progress of the Body Surface Area index in DMF treatment in the 52 weeks. Progress in Visual Analogue Scale (EVA) of pruritus in the treatment with DMF in the 52 weeks. Progress of the Dermatology Life Quality index Index treatment with DMF in the 52 weeks. Patients´satisfaction with DMF treatment by EVA after 52 weeks. Safety of DMF treatment in the 52 weeks. Demographic and clinical features in patients with chronic moderate-severe plaque psoriasis initiating DMF. Describe treatments for moderate to severe plaque psoriasis (topical, phototherapy or systemic) prior to initiation with DMF. Safety of DMF during treatment.;Primary end point(s): Percentage of patients achieving a reduction equal to greater than 75% in PASI compared to baseline (PASI75);Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients achieving PASI75 at w4, w8, w12, w36, w48 and w52 - Percentage of patients achieving PASI50 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PASI90 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PASI100 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PASI = 5 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PASI = 3 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PASI = 1 at w4, w8, w12, w24, w36, w48 and w52 - Mean % change from baseline in PASI at w4, w8, w12, w24, w36, w48 and w52 - Mean % change from baseline in BSA at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PGA 0-1 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving PGA = 2 at w4, w8, w12, w24, w36, w48 and w52 - Mean % change from baseline in DLQI at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving DLQI = 5 at w4, w8, w12, w24, w36, w48 and w52 - Percentage of patients achieving DLQI 0-1 at w4, w8, w12, w24, w36, w48 and w52 - Mean % change from baseline in pruritus/pain (VAS) at w4, w8, w12, w24, w36, w48 and w52 - Mean patient satisfaction (VAS) at w24 and w52;Timepoint(s) of evaluation of this end point: Weeks 4, 8, 12, 24, 36, 48 and 52 | — |
Countries
Spain
Contacts
Public ContactDepartamento de Ensayos Clínicos
Dynamic
Outcome results
None listed