A multi-center, randomized, double-blind, three-arm, 16 week, adaptive phase III clinical study to investigate the efficacy and safety of LAS41008 vs LASW1835 and vs placebo in patients with moderate to severe chronic plaque psoriasis
- Conditions
- Psoriasispsoriasis vulgaris10014982
- Registration Number
- NL-OMON39748
- Lead Sponsor
- Almirall
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
- 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 following wash-out periods :
2 weeks : Corticosteroids, Vitamin A analogues, Vitamin D analogues, Anthracene derivatives, Tar, Salicylic acid preparations
3 months : Biologics with antipsoriatic activity
1 month : Conventional systemic antipsoriatic drugs and phototherapy
6 months: Immunosuppressive medication (if not covered by any of the above treatments)
- 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 (including those who have had vasectomy) 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
- 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
- Are detected to have abnormal liver enzymes
(a) if an enzyme is >3x the upper limit of the normal range (AST (SGOT) ALT (SGPT),
gamma-GT, alkaline phosphatase (ALP))
(b) if bilirubin is >2xULN, for the other liver enzymes >2xULN
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy variables are:<br /><br>- PASI 75 (= Response)<br /><br>- Proportion of subjects achieving a score of clear or almost clear in the<br /><br>Physician's Global Assessment (PGA)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- PASI 50, PASI 75, PASI 90, PASI 125<br /><br>- Proportion of subjects achieving a score of clear or almost clear in the<br /><br>Physician's Global Assessment (PGA)<br /><br>- Body Surface Area (BSA)<br /><br>- Treatment Success rate<br /><br>- Remission rate<br /><br>- Time to Relapse<br /><br>- Time to Rebound (worsening of psoriasis over baseline value (PASI > 125%))<br /><br>- Patient Benefit Index based on the Patient Need Questionnaire (PNQ) and the<br /><br>Patient Benefit Questionnaire (PBQ)</p><br>