A multi-center, randomized, clinical trial to compare the efficacy and safety of a new drug with Fumaderm in patients with moderate to severe plaque psoriasis

• Conditions: moderate to severe chronic plaque psoriasis; MedDRA version: 17.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; MedDRA version: 17.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-000055-13-PL
• Lead Sponsor: Almirall S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-05
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 690

Inclusion Criteria

- Signed and personally dated written informed consent
- Male / female
- Aged 18 years or older
- With a diagnosis of chronic plaque psoriasis for at least 12 months before enrollment in the study
- With the severity of psoriasis defined as moderate to severe, as reflected in meeting all the following criteria:
PASI > 10
BSA (body surface area) > 10 %
PGA moderate to severe
- 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
- Prior therapy with systemic drugs for psoriasis that was discontinued e.g. due to an adverse event or insufficient effect, or naïve to systemic treatment but identified as a candidate for systemic treatment.
- With a complete record of at least 12 months of other previous topical and systemic treatments, if any
- Adhering to the wash-out periods as stated in the protocol
- 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 and for 60 days after the last dose of investigational product. Additionally they must agree to have pregnancy tests while on study medication. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- Males (exept vasectomized males) must agree to use barrier contraception while on study medication
- Willing to keep sun exposure reasonably constant and not to use tanning booths or other 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 590
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- For females: pregnant or lactating
- With a diagnosis of guttate, erythrodermic or pustular psoriasis
- With a hematological abnormality as follows: platelet count < 100,000/mm3, WBC count < 3,000 cells/ mm3, lymphocyte count < 1.000/µl, hemoglobin, hematocrit, or red blood cell count outside 30 % of the upper or lower limits of normal for the lab
- With a history of malignancies except for non melanoma skin cancer
- Suffering from significant gastrointestinal problems (ulcers, diarrhea, etc.)
- Known to have severe renal impairment (creatinine clearence<30 mL/min)
- Are detected to have abnormal liver enzymes (Guidance for Industry 2009)
a) in an enzyme is >3x the upper limit of the normal range (AST (SGOT) ALT (SGPT), gamma-GT, alkaline phophatase (ALP))
b) if bilirubine is >2x ULN, for the other liver enzymes>2xULN is exclusionary
- With active infectious disease
-On systemic therapy with drugs that may interfere with the investigational products taken within the defined wash-out period
- With a history of alcohol or drug abuse
- Known HIV-positive status or suffering from any other immunosuppressive disease
- Known to be hypersensitive to ingredients of the investigational products
- Previous enrolled in this study or participating in any other drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment.
- Not willing to give consent for transmission of personal pseudonymised data
- Unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
-Previously failes therapy with fumaric acid esters either due to inadequate efficacy or lack of tolerability.

Study & Design

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