LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726933
• Other study ID #: M41008-1102
• Secondary ID: 2012-000055-13
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2012
• Last updated: December 1, 2015
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthAustria: Agency for Health and Food SafetyThe Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: November 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• LAS41008
gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
• LASW1835
gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
• Placebo
gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Locations

Country	Name	City	State
Austria	Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site	Various
Germany	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	Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows:Almirall Investigative Site #	Various

Sponsors (3)

Lead Sponsor	Collaborator
Almirall, S.A.	Almirall Hermal GmbH, Harrison Clinical Research

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Benefit Index, PBI	Calculation of individual benefit from therapy, assessed by patient at week 16 and in follow up	week 16	No
Primary	PASI 75	Reduction of PASI by 75% from baseline to week 16	16 weeks	No
Primary	Physician Global Assessment, PGA	Change in PGA from baseline to week 16	16 weeks	No
Secondary	Body Surface Area, BSA	Change in BSA from baseline to week 3, 8, 16 and follow up	16 weeks	No
Secondary	Dermatological Life Quality Index, DLQI	Change in DLQI from baseline to week 3, 8, 16 and follow up	16 weeks	No
Secondary	PASI 75	Change in PASI 75 from baseline to week 3 and 8 and follow up	week 3 and 8	No
Secondary	PGA	Change in PGA from baseline to week 3 and 8 and follow up	week 3 and 8	No
Secondary	Adverse events	Ongoing safety profile over the course of the study (treatment phase and follow up)	ongoing	Yes