Clinical study to evaluate the efficacy and safety of a combination therapy with dimethyl fumarate (DMF) and NB-UVB phototherapy (versus DMF monotherapy) in adults with moderate-to-severe chronic plaque psoriasis (PHOTOSKILL) - PHOTOSKILL study

Almirall, S.A.0 sites150 target enrollmentJuly 30, 2019

DrugsSkilarence

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Almirall, S.A.
Enrollment: 150
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Almirall, S.A.

Eligibility 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

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 \<100,000/mm3, white blood cells (WBC) count \< 3,000 cells/ mm3, lymphocyte count \< 1,000/µL, haemoglobin, haematocrit, or red blood cell count outside 30% of the upper or lower limits of normal
•for the laboratory.
•7\-History or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
•8\- Presence of severe photodamage, actinic keratosis and/or clinically/histologically atypical moles.
•9\- Patients suffering from active significant gastrointestinal problems (ulcers, diarrhoea, etc.).