Psoriasis vulgaris MedDRA version: 16.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: metex® 50mg/ml solution for injection
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-
Sponsors
Prof. Dr. Kristian Reich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the study, patients must meet all of the following criteria: 1. Are 18 years of age or older at time of informed consent; may be men or women. 2. Are MTX naïve 3. Moderate to severe plaques psoriasis (according rule of ten (PASI =10 or BSA = 10 or DLQI = 10) for at least 6 months with or without psoriatic arthritis (however,highly active psoriatic arthritis is excluded, defined by > 5 swollen tender joints or soles and CRP >2 x UNL) . 4. Women of childbearing potential and all men must be using a highly effective method of contraception (pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria may not be enrolled in the study: 1.Currently have non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular). 2.Have current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, (hydroxy-) chloroquine, or lithium). 3.Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study. 4.Have screening laboratory test results for the following parameters outside the stated ranges (please refer also to : a.Hemoglobin 2 times the upper limit of normal range g.Bilirubin > 5mg/dl (85,5 µmol/l) h.Hypalbuminemia Washout requirements (all times with regard to first s.c. administration of the IMP)] : 6.1 Any biologics --> 5 times of half-life 6.2 Phototherapy or any systemic medications that could affect the psoriasis (including but not limited to oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, sulfasalazine, hydroxyurea, or fumaric acid derivates) -->Within 4 weeks 6.3 Any topical medications that could affect the psoriasis (e.g. corticosteroids, anthralin, calcipotriene, topical vitamin D derivates, retinoids, tazarotene) -->Within 2 weeks 6.4 Any systemic immunosuppressants (e.g. azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) --> Within 4 weeks 6.5 lithium, antimalarial agents --> To be stopped directly prior to first s.c. administration of IMP 6.6 Intramuscular gold --> Within 4 weeks Patients who take prohibited medications that cannot be washed out within 4 weeks or at least 5 times of the half-life of the investigational agent prior to first s.c. administration of IMP should not be asked to participate in the trial. 7.Have a history of chronic or recurrent infectious disease or had a serious infection or have been hospitalized or received i.v. antibiotics for the treatment of an infection within 2 months prior to screening. 8. History of radiotherapy or planed concomitant radiotherapy 9. Ulcers of the oral cavity (e.g. ulcerative stomatitis) and/or known gastrointestinal ulcer disease 10. A known B12/cobalamin deficiency 11. Known diagnosed ascites or pleural effusions 12.Have a history of latent or active TB ( prior to screening). 13.Have current signs or symptoms of severe, progressive, or uncontrolled renal (specifically with calculated creatinine clearance 5mg/dl (85,5 mol/l), hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease. 14.Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the fir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of subcutaneous application of MTX in patients with moderate to severe psoriasis compared to placebo as determined by the number of patients reaching the primary endpoint PASI 75 after a 16 week treatment phase in the two study arms.;Secondary Objective: The following endpoints, which evaluate the efficacy, tolerability and safety are assessed: •PASI75 after 52 weeks treatment •PASI50 and 90 after 16 and 52 weeks treatment •PASI75 after 32 weeks treatment in placebo arm (cross-over) •NAPSI, BSA, PGA, , PsA and questionnaires such as PSAT metex® , EQ-5D and DLQI after 16 and 52 weeks treatment •Safety and tolerability assessed by AE/SAE, laboratory values and local tolerability at the injection site • RESTRICTED TO GERMAN SITES (Sub-Study): Changes of levels of molecular biologic analysis (UBC + B2M as housekeeping gens; TNF-a, IL-17, IL-4, IFN-gamma) and immunohistochemistry analysis (CD3, CD1a, Ki67) at baseline and after 16 weeks (at 3 sites for approx. 30 patients); for explorative scientific purpose only The data up to week 16 will be analyzed regarding the difference between verum and placebo treatment. The data from week 16 to week 52 will be analyzed regarding long term treatment effects in a descriptive manner only. ;Primary end point(s): PASI75 after 16 weeks;Timepoint(s) of evaluation of this end point: week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •PASI75 after 52 weeks treatment •PASI50 and 90 after 16 and 52 weeks treatment •PASI75 after 32 weeks treatment in placebo arm (cross-over) •NAPSI, BSA, PGA, PsA and questionnaires such as PSAT metex®, EQ-5D and DLQI after 16 and 52 weeks treatment •Safety and tolerability assessed by AE/SAE, laboratory values and local tolerability at the injection site from V1- V10 •Changes of levels of molecular biologic analysis (UBC and B2M as housekeeping gens; TNF-a, IL-17, IL-4, IFN-gamma) and immunohistochemistry analysis (CD3, CD1a, Ki67) at baseline and after 16 weeks (at 3 sites for approx. 30 patients); for explorative scientific purpose only The data up to week 16 will be analyzed regarding the difference between verum and placebo treatment. The data from week 16 to week 52 will be analysed regarding long term treatment effects in a descriptive manner only. ;Timepoint(s) of evaluation of this end point: refer to E.5.2 | — |
Countries
France, Germany, Netherlands, United Kingdom
Contacts
Public ContactProject Management
SCIderm GmbH
Outcome results
None listed