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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000055-13 | EudraCT Number |
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| Name | Class |
|---|---|
| Almirall Hermal GmbH | INDUSTRY |
| Harrison Clinical Research | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS41008 | Experimental | up to 6 tablets/ day for 16 weeks double blind treatment period, randomized gastric resistant tablet |
|
| Placebo | Placebo Comparator | up to 6 tablets/ day for 16 weeks randomized, double blind gastric resistant tablet |
|
| LASW1835 | Active Comparator | double blind, randomized gastric resistant tablet up to 6 tablets/ day for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41008 | Drug | gastric resistant tablet, weekly up-titration up to maximal tolerated dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Surface Area, BSA | Change in BSA from baseline to week 3, 8, 16 and follow up | 16 weeks |
| Dermatological Life Quality Index, DLQI | Change in DLQI from baseline to week 3, 8, 16 and follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Benefit Index, PBI | Calculation of individual benefit from therapy, assessed by patient at week 16 and in follow up | week 16 |
Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Mrowietz, MD, Prof | University Medical Center, Schleswig-Holstein, Department of Dermatology, Schittenhelmstr. 7, 24105 Kiel, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigatives site names will not be disclosed to avoid competitive information. Specify at least one site as follows: Almirall Investigative Site | Various | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31033034 | Derived | 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. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| LASW1835 | Drug | gastric resistant tablet, weekly up-titration up to maximal tolerated dosage |
|
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| Placebo | Drug | gastric resistant tablet, weekly up-titration up to maximal tolerated dosage |
|
| 16 weeks |
| PASI 75 | Change in PASI 75 from baseline to week 3 and 8 and follow up | week 3 and 8 |
| PGA | Change in PGA from baseline to week 3 and 8 and follow up | week 3 and 8 |
| Adverse events | Ongoing safety profile over the course of the study (treatment phase and follow up) | ongoing |
| 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 |
| D009930 |
| Organic Chemicals |