LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: LAS41008; Drug: Placebo; Drug: LASW1835

• Registration Number: NCT01726933
• Lead Sponsor: Almirall, S.A.

Brief Summary

The aim of the study is to evaluate the efficacy and safety of LAS41008 in comparison to active control and placebo in patients with moderate to severe chronic plaque psoriasis

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-15
• Primary Completion: 2014-10
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 839

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAS41008	LAS41008	up to 6 tablets/ day for 16 weeks double blind treatment period, randomized gastric resistant tablet
Placebo	Placebo	up to 6 tablets/ day for 16 weeks randomized, double blind gastric resistant tablet
LASW1835	LASW1835	double blind, randomized gastric resistant tablet up to 6 tablets/ day for 16 weeks

Primary Outcome Measures

Name	Time	Method
Physician Global Assessment, PGA	16 weeks	Change in PGA from baseline to week 16
PASI 75	16 weeks	Reduction of PASI by 75% from baseline to week 16

Secondary Outcome Measures

Name	Time	Method
PASI 75	week 3 and 8	Change in PASI 75 from baseline to week 3 and 8 and follow up
Body Surface Area, BSA	16 weeks	Change in BSA from baseline to week 3, 8, 16 and follow up
Dermatological Life Quality Index, DLQI	16 weeks	Change in DLQI from baseline to week 3, 8, 16 and follow up
Adverse events	ongoing	Ongoing safety profile over the course of the study (treatment phase and follow up)
PGA	week 3 and 8	Change in PGA from baseline to week 3 and 8 and follow up

Trial Locations

Locations (2)

Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site; 🇳🇱 Various, Netherlands

Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows:Almirall Investigative Site #; 🇵🇱 Various, Poland