LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT01726933

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 839 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-11-30

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

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LAS41008

up to 6 tablets/ day for 16 weeks double blind treatment period, randomized gastric resistant tablet

Group Type: EXPERIMENTAL

LAS41008

Intervention Type: DRUG

gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Placebo

up to 6 tablets/ day for 16 weeks randomized, double blind gastric resistant tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

LASW1835

double blind, randomized gastric resistant tablet up to 6 tablets/ day for 16 weeks

Group Type: ACTIVE_COMPARATOR

LASW1835

Intervention Type: DRUG

gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Interventions

LAS41008

gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Intervention Type: DRUG

LASW1835

gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Intervention Type: DRUG

Placebo

gastric resistant tablet, weekly up-titration up to maximal tolerated dosage

Intervention Type: DRUG

Other Intervention Names

Verum; Fumaderm initial/ Fumaderm

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall Hermal GmbH

INDUSTRY

Sponsor Role: collaborator

Harrison Clinical Research

INDUSTRY

Sponsor Role: collaborator

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrich Mrowietz, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Medical Center, Schleswig-Holstein, Department of Dermatology, Schittenhelmstr. 7, 24105 Kiel, Germany

Locations

Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site

Various, , 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

Countries

Austria; Germany; Netherlands; Poland

References

Warren RB, Barker JNW, Van de Kerkhof P, Reich K, Mrowietz U. Switching from a fumaric acid ester mixture to dimethylfumarate monotherapy in psoriasis. J Eur Acad Dermatol Venereol. 2019 Oct;33(10):e352-e353. doi: 10.1111/jdv.15644. Epub 2019 May 10. No abstract available.

Reference Type: DERIVED

PMID: 31033034 (View on PubMed)

Other Identifiers

2012-000055-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M41008-1102

Identifier Type: -

Identifier Source: org_study_id