LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

NCT01726933 | Completed Phase 3 DMC

• 2 other identifiers: M41008-11022012-000055-13
• Study Type: interventional
• Target: 839
• Locations: 4 countries
• Sites: 4

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

Keywords

psoriasis, systemic treatment

Outcome Measures

Primary Outcomes (2)

• PASI 75

  Reduction of PASI by 75% from baseline to week 16

  16 weeks

• Physician Global Assessment, PGA

  Change in PGA from baseline to week 16

  16 weeks

Secondary Outcomes (5)

• Body Surface Area, BSA

  16 weeks

• Dermatological Life Quality Index, DLQI

  16 weeks

• PASI 75

  week 3 and 8

• PGA

  week 3 and 8

• Adverse events

  ongoing

Other Outcomes (1)

• Patient Benefit Index, PBI

  week 16

Study Arms (3)

LAS41008

EXPERIMENTAL

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

Drug: LAS41008

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

LASW1835

ACTIVE COMPARATOR

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

Drug: LASW1835

Interventions

LAS41008 DRUG

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

Also known as: Verum

LAS41008

LASW1835 DRUG

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

Also known as: Fumaderm initial/ Fumaderm

LASW1835

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 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
• 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

You may not qualify if:

• 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 significant renal impairment
• Are detected to have abnormal liver enzymes \>2x the upper limit of the normal range
• 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

Sponsors & Collaborators

• Almirall, S.A.: lead
• Almirall Hermal GmbH: collaborator
• Harrison Clinical Research: collaborator

Study Sites (4)

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

Various, Austria

Location

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

Various, Germany

Location

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

Various, Netherlands

Location

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

Various, Poland

Location

Related Publications (1)

• 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.

  PMID: 31033034 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

calcium D-pantothenate, L-cysteine drug combination; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ulrich Mrowietz, MD, Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 15, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

DE (1); NL (1); AU (1); PL (1)