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)

Phase 1

• Conditions: Moderate to severe chronic plaque psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-000818-11-PT
• Lead Sponsor: Almirall, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-30
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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 <45 years of age, or cessation of menses is more than 3 months and less than 1 year, follicle stimulating hormone must be documented as elevated into the postmenopausal range (>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 30 days after the last dose of the study drug
Explanatory note: Highly effective methods of birth control are defined as a method with less than 1% failure rate per year which include:
combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation1 (oral, injectable, implantable2), intrauterine device, intrauterine hormone-releasing system 2, bilateral tubal occlusion 2, vasectomised partner 2,3, and sexual abstinence 4.
1 Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of the contraception method.
2 Contraception methods that are considered to have low user dependency (according to the CTFG recommendations on contraception and pregnancy testing).
3 Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the woman who is considered of childbearing potential study participant and that the vasectomised partner has received medical assessment of the surgical success.
4 Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of the risk associated with the study treatments. The

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.).
10-Patients with severe renal impairment (creatinine clearance <30 mL/min, estimated glomerular filtration rate (eGFR) using CKD-EPI Creatinine Equation or significant proteinuria (3+ or higher)
11-Patients with abnormal liver enzymes:
-if an enzyme was >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 (e.g. cytostatics, etc.):

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified