Prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-046 / StelaraÃ?Â® in patients with moderate to severe plaque psoriasis

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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 Ã¢â?°Â¥10% BSA involvement and PASI score Ã¢â?°Â¥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 Ã¢â?°Â¥ 10 g/dL
•b White blood cells Ã¢â?°Â¥ 3.5 x 109/L
•c Neutrophils Ã¢â?°Â¥ 1.5 x 109/L
•d Platelets Ã¢â?°Â¥ 100 x 109/L
•e Serum creatinine Ã¢â?°Â¤ 1.5 mg/dL
•f AST and ALT Ã¢â?°Â¤2 times the upper limit of normal
•g Alkaline phosphatase levels Ã¢â?°Â¤2 times the upper limit of normal

•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.

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