LAS41008 in Moderate to Severe Chronic Plaque Psoriasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Almirall, S.A.
Sponsor:
Collaborators:
Almirall Hermal GmbH
Harrison Clinical Research
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01726933
First received: November 12, 2012
Last updated: October 9, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Plaque Psoriasis
Drug: LAS41008
Drug: LASW1835
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • PASI 75 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Reduction of PASI by 75% from baseline to week 16

  • Physician Global Assessment, PGA [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change in PGA from baseline to week 16


Secondary Outcome Measures:
  • Body Surface Area, BSA [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change in BSA from baseline to week 3, 8, 16 and follow up

  • Dermatological Life Quality Index, DLQI [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change in DLQI from baseline to week 3, 8, 16 and follow up

  • PASI 75 [ Time Frame: week 3 and 8 ] [ Designated as safety issue: No ]
    Change in PASI 75 from baseline to week 3 and 8 and follow up

  • PGA [ Time Frame: week 3 and 8 ] [ Designated as safety issue: No ]
    Change in PGA from baseline to week 3 and 8 and follow up

  • Adverse events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
    Ongoing safety profile over the course of the study (treatment phase and follow up)


Other Outcome Measures:
  • Patient Benefit Index, PBI [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Calculation of individual benefit from therapy, assessed by patient at week 16 and in follow up


Estimated Enrollment: 690
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS41008
up to 6 tablets/ day for 16 weeks double blind treatment period, randomized gastric resistant tablet
Drug: LAS41008
gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
Other Name: Verum
Placebo Comparator: Placebo
up to 6 tablets/ day for 16 weeks randomized, double blind gastric resistant tablet
Drug: Placebo
gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
Active Comparator: LASW1835
double blind, randomized gastric resistant tablet up to 6 tablets/ day for 16 weeks
Drug: LASW1835
gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
Other Name: Fumaderm initial/ Fumaderm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726933

Contacts
Contact: Veronica Tebbs, MD +49 40 72704 ext 0 veronica.tebbs@almirall.com
Contact: Godehard Ocker, PhD +49 40 72704 ext 0 godehard.ocker@almirall.com

Locations
Austria
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site Recruiting
Various, Austria
Principal Investigator: NN         
Germany
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site Recruiting
Various, Germany
Principal Investigator: Investigator NN         
Netherlands
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site Recruiting
Various, Netherlands
Principal Investigator: NN         
Poland
Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows:Almirall Investigative Site # Recruiting
Various, Poland
Principal Investigator: NN         
Sponsors and Collaborators
Almirall, S.A.
Almirall Hermal GmbH
Harrison Clinical Research
Investigators
Principal Investigator: Ulrich Mrowietz, MD, Prof University Medical Center, Schleswig-Holstein, Department of Dermatology, Schittenhelmstr. 7, 24105 Kiel, Germany
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01726933     History of Changes
Other Study ID Numbers: M41008-1102, 2012-000055-13
Study First Received: November 12, 2012
Last Updated: October 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Austria: Agency for Health and Food Safety
The Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)

Keywords provided by Almirall, S.A.:
psoriasis, systemic treatment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014