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A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3) — INDUS-3  

Plaque Psoriasis Clinical Trial

Official title:
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 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 128 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 four groups (three dose groups of AUR101 and one placebo group) in the ratio of 1:1:1:1. The patients in each arm will receive AUR101 of 200 mg twice daily, 400 mg twice daily, 400 mg once daily or matching placebo for 16 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

Clinical Trial Details
NCT number NCT04855721
Study type Interventional
Source Aurigene Discovery Technologies Limited
Contact
Status Completed
Phase Phase 2
Start date May 4, 2021
Completion date December 10, 2022
View Details
See also
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