Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: R-TPR-046: at week 0, week 4, week 16, week 28 and week 40
Control Intervention1: Stelara: at week 0, week 4, week 16, week 28 and week 40
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female between 18 and 65 years of age, inclusive. 2 Patients with diagnosis of plaque-type psoriasis at least 6 months prior to first administration of study drug. 3 Patients with moderate to severe plaque psoriasis with �10% BSA involvement and PASI score �12 at screening. 4 Patients who are potential candidates for phototherapy or systemic treatment of psoriasis. 5 Must have screening laboratory test results within acceptable limits as defined below: a Hemoglobin � 10 g/dL b White blood cells � 3.5 x 109/L c Neutrophils � 1.5 x 109/L d Platelets � 100 x 109/L e Serum creatinine � 1.5 mg/dL f AST and ALT �2 times the upper limit of normal g Alkaline phosphatase levels �2 times the upper limit of normal
Exclusion criteria
Exclusion criteria: 1 Patients with non-plaque forms of psoriasis (eg, erythrodermatic, guttate, or pustular). 2 Patients with current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium). 3 Pregnant, nursing females or planning pregnancy (both males and females) during the study period until 12 months after receiving the last injection of study drug. 4 Use of any therapeutic agent targeted at reducing lL-12 or IL-23, including but not limited to Ustekinumab. 5 Patients who have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks prior to first administration of study drug. 6 Use of topical medications/treatments that could affect psoriasis or PASI evaluation (eg. corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens) within 2 weeks prior to first administration of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving PASI 75 responseTimepoint: at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Proportion of patients achieving PASI 50,75,90,100 response 2 Proportion of patients achieving Physician Global Assessment (PGA) score of ââ?¬Ë?clearedââ?¬â?¢ or ââ?¬Ë?minimalââ?¬â?¢ 3 Change in Dermatology Life Quality Index (DLQI) from baseline upto 4 Proportion of patients achieving DLQI score of 0 or 1 5 Improvement in Short Form 36 Health Survey Questionnaire (SF-36) score from baseline 6 Single dose and multiple dose pharmacokinetic assessment of R-TPR-046 and StelaraÃ?® Timepoint: at week 52 | — |
Countries
India
Contacts
Public ContactSachin Singh
Reliance Life Sciences Pvt. Ltd.
Outcome results
None listed