Moderate to severe 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: Skilarence
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Conce
Sponsors
Almirall
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Ability to understand and comply with the requirements of the study and communicate with the Investigator, and written, signed and dated informed consent given before any study related activity is performed. 2-Male or female must be at least 18 years of age at the time of Screening Visit. 3-Patients diagnosed with chronic plaque psoriasis of at least 6 months prior to the Screening Visit, and stable active plaque-type psoriasis (defined as without clinically significant flares during the 12 weeks before randomisation). 4-Patients with the severity of psoriasis at Screening and Baseline visits defined by PASI score >5. 5-Candidates whose disease is eligible for systemic treatment and PT (i.e. with lesions in areas that can be irradiated) at the Screening Visit. 6-Patients who are PT naïve or who have not had PT at least 6 months before the Screening Visit. 7-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 (within normal or clinically acceptable range limits) and physical examination (no clinical significant abnormal findings). Investigators are encouraged to consult with the Sponsor if there are questions regarding the significance of any out of range values. 8-Complete record of at least the last 12 months prior to the Screening Visit of anti-psoriatic previous topical, PT and non-biologic systemic treatments, if any. 9-Unlikely to conceive, as indicated by at least one “yes” answer to the following questions -Patient is a male -Patient is a surgically sterilized female by hysterectomy or bilateral tubal ligation -Patient is a postmenopausal female =45 years of age with >1 year since last menses. If a patient is 60 mIU/mL) at the Screening visit -Patient is a non-sterilized and pre-menopausal female using a highly effective medically accepted method of contraception, during the study period and for 60 days after the last dose of the study drug 10-For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit. Additionally, they must agree to have urine pregnancy tests while on study medication. 11-Patients willing to keep sun exposure of the trunk and limbs to none or minimal, occasional and unintentional, and not to use tanning booths or other ultraviolet (UV) light sources for the duration of the trial. 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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1-Female patients who are currently pregnant, who intend to become pregnant during the course of the study, or who are breastfeeding, unwillingness/inability to use appropriate measures of contraception 2- Patients with a diagnosis of flexural, guttate, erythrodermic or pustular psoriasis 3- Patients with a diagnosis and/or signs/symptoms suggestive of active psoriatic arthritis 4- Drug-induced psoriasis (i.e., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel blockers, or lithium) 5-History or evidence of skin disease (atopic dermatitis, eczema) or conditions (scarring, open wounds) other than chronic plaque-type psoriasis that might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation 6-Patients with a haematological abnormality at the Screening Visit as follows: platelet count 3x the upper limit of the normal range (ULN): aspartate amino transferase (AST or SGOT), alanine amino transferase (ALT or SGPT), gamma-glutamyl-transferase (GGT), alkaline phosphatase (ALP) - if bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary 12-Patients with active infectious disease 13- Patients on systemic therapy 14- Patients with concomitant treatment with immunomodulating or immunosuppressive medication, or systemic corticosteroids 15- History of hypersensitivity or allergy to the study drugs or its excipients 16- Patients with history or evidence/indication of current drug and/or alcohol abuse or dependence, according to the judgment of the Investigator 17- Patients with HIV-positive status or any other immunosuppressive disease 18-Patients who have had a live vaccination within 4 weeks prior to the Baseline Visit, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within 12 weeks of randomization 19-Patient who intend to use any concomitant medication not permitted by this study or who have not undergone the required washout period, prior to the Baseline Visit, for a particular prohibited medication: -Topical psoriasis treatment (e.g. topical corticosteroids, vitamin A analogues, vitamin D analogues, coal tar, anthracene derivatives, salicylic acid preparations): 2 weeks -PT (other than the study PT, e.g. Psoralen-UVA therapy, tanning salon or homeadministered UVB): 6 months -Conventional systemic anti-psoriatic drugs, excluding fumarate-based drugs and PT: 4 weeks -Any other immunosuppressive medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To assess the efficacy of a DMF/NB-UVB PT combination regimen and DMF treatment alone (as assessed by PASI, BSA, and PGA. 2. To assess the time to achieve a clinically meaningful improvement (as assessed by PASI) of a DMF/ NB-UVB PT combination regimen and DMF treatment alone. 3. To assess the efficacy of DMF/ NB-UVB PT combination regimen and DMF treatment alone according to patient-reported outcomes (PRO) (DLQI, Skindex-16, pruritus-VAS, and WPAI). 4. To assess cost-effectiveness (as assessed by health resources utilisation [HRU] and EQ-5D) of a DMF/ NB-UVB PT combination regimen and DMF treatment alone. 5. To assess the safety and tolerability of a DMF/ NB-UVB PT combination regimen and DMF treatment alone. 6. To assess adherence rate and patient satisfaction of a DMF/ NB-UVB PT combination regimen and DMF treatment alone.;Main Objective: To assess the efficacy of a DMF/NB-UVB PT combination regimen and DMF treatment alone in patients with moderate-to-severe chronic plaque psoriasis, as assessed by PASI 75 or PASI =3.;Primary end point(s): Proportion of patients achieving “PASI 75 response OR PASI =3” at 24 weeks of treatment;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints -Proportion of patients achieving a PASI 75 response at 24 weeks of treatment. -Proportion of patients achieving an absolute PASI score of =3 at 24 weeks of treatment. -Proportion (and number) of patients achieving PASI 75, PASI 90 responses as well as absolute PASI score of =5, =3 and =1 all visits*. -Absolute PASI score and percentage change from baseline in the absolute PASI score at all visits*. -Proportion (and number) of patients with a PGA score of 0 or 1 (‘clear’ or ‘almost clear’) at all visits*. -Absolute PGA score and change from baseline in the absolute PGA score at each visit*. -Absolute BSA score and change from baseline in the absolute BSA score at each visit*. -Time to achieve the primary composite endpoint (PASI 75 response OR to PASI score =3) -Time to PASI 75 response. -Time to PASI score = 3. -Absolute DLQI score and percentage change from baseline in the absolute DLQI score at all visits*. -Proportion of patients achieving a DLQI score of 0 or 1 at all visits*. -Absolute Skindex-16 score and change from baseline in the absolute Skindex-16 score at all visits*. -Absolute pruritus-VAS score and change from baseline in the absolute pruritus-VAS score at all visits*. -Absolute WPAI score and change from baseline in the absolute WPAI score at all visits* * When the data is collected -HRU related to psoriasis collected at Week 24: • Number of visits related to psoriasis (including unscheduled) • Treatments related to psoriasis (including dose, route, frequency, duration, onset date, end date, and reasons for onset and discontinuation • Number of hospitalisation/s related to psoriasis (if any, number of hospitalisations and length [days]) • Number of unscheduled/emergency room visits to the general practitioner/dermatologist related to psoriasis (if any, number [days] • Diagnostic procedures related to psoriasis (clinical examination, laboratory controls, biopsy [if any], others) • Perce | — |
Countries
Denmark, Italy, Norway, Portugal, Spain, Sweden
Contacts
Public ContactInternat. Clinical Trial Manager
Almirall
Outcome results
None listed