LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT01726933
• Date of registration: 12/11/2012
• Prospective Registration: No
• Primary sponsor: Almirall, S.A.
• Public title: LAS41008 in Moderate to Severe Chronic Plaque Psoriasis
• Scientific title: 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
• Date of first enrolment: November 2012
• Target sample size: 839
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01726933
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria, Germany, Netherlands, Poland

Contacts

• Name: Ulrich Mrowietz, MD, Prof
• Affiliation: University Medical Center, Schleswig-Holstein, Department of Dermatology, Schittenhelmstr. 7, 24105 Kiel, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed and personally dated written informed consent

2. Male / female

3. Aged 18 years or older

4. With a diagnosis of chronic plaque psoriasis for at least 12 months before enrollment
in the study

5. 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

6. 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

7. Prior therapy with systemic drugs for psoriasis or naïve to systemic treatment but
identified as a candidate for systemic treatment.

8. With a complete record of at least 12 months of other previous topical and systemic
treatments, if any

9. Adhering to the following wash-out periods Topical treatment Wash-out Period
Corticosteroids Vitamin A analogues Vitamin D analogues Anthracene derivatives Tar
Salicylic acid preparations 2 weeks Systemic treatment Biologics with antipsoriatic
activity 3 months Conventional systemic antipsoriatic drugs and phototherapy 1 month
Immunosuppressive medication (if not covered by any of the above treatments)
Cytostatics 6 months Medications with known harmful influences on the kidneys 5 x
halftime

10. 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.

11. Males (including those who have had vasectomy) must agree to use barrier
contraception while on study medication

12. Willing to keep sun exposure reasonably constant and not to use tanning booths or
other UV light sources for the duration of the trial

Exclusion Criteria:

1. For females: pregnant or lactating

2. With a diagnosis of guttate, erythrodermic or pustular psoriasis

3. 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

4. With a history of malignancies except for non melanoma skin cancer

5. Suffering from significant gastrointestinal problems (ulcers, diarrhea, etc.)

6. Known to have significant renal impairment

7. Are detected to have abnormal liver enzymes >2x the upper limit of the normal range

8. With active infectious disease

9. On systemic therapy with drugs that may interfere with the investigational products
taken within the defined wash-out period

10. With a history of alcohol or drug abuse

11. Known HIV-positive status or suffering from any other immunosuppressive disease

12. Known to be hypersensitive to ingredients of the investigational products

13. 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.

14. Not willing to give consent for transmission of personal "pseudonymised" data

15. Unable to comply with the requirements of the study or who in the opinion of the
investigator should not participate in the study



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Plaque Psoriasis

Intervention(s)

Drug: LAS41008

Drug: LASW1835

Drug: Placebo

Primary Outcome(s)

PASI 75 [Time Frame: 16 weeks]

Physician Global Assessment, PGA [Time Frame: 16 weeks]

Secondary Outcome(s)

Dermatological Life Quality Index, DLQI [Time Frame: 16 weeks]

Body Surface Area, BSA [Time Frame: 16 weeks]

PASI 75 [Time Frame: week 3 and 8]

PGA [Time Frame: week 3 and 8]

Adverse events [Time Frame: ongoing]

Secondary ID(s)

M41008-1102

2012-000055-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Harrison Clinical Research

Almirall Hermal GmbH