A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Plaque Psoriasis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: There are 6 groups in the study; 1 with placebo and 5 with different AUR101 dosing regimensMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind, double-dummyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 Severit...
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.
Tracking Information
- NCT #
- NCT04855721
- Collaborators
- Not Provided
- Investigators
- Study Director: Divyesh Mandavia, MD Aurigene Discovery Technologies Limited
Get Well Soon