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Clinical Trial Summary

A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized Study to Evaluate the Efficacy and Safety of AUR101 in patients with Moderate-to-Severe Psoriasis (INDUS-3)


Clinical Trial Description

This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate the efficacy and safety of AUR101 in patients with moderate-to-severe psoriasis. Approximately 108 patients with chronic moderate-to-severe plaque psoriasis (defined as Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface Area (BSA) involved ≥10%) will be randomized to six groups (five dose groups of AUR101 and one placebo group) in the ratio of 1:1:1:1:1:1. The patients in each arm will receive AUR101 of 100 mg twice daily, 200 mg twice daily, 300 mg twice daily, 400 mg twice daily, 400 mg once daily or matching placebo for 12 weeks in a double blind, double dummy fashion. All patients will be followed up for 14 ± 2 days of their last dose for safety assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04855721
Study type Interventional
Source Aurigene Discovery Technologies Limited
Contact Shilendra Pandey, MSc
Phone +919873554523
Email sh[email protected]
Status Not yet recruiting
Phase Phase 2
Start date May 15, 2021
Completion date April 15, 2022

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