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

Phase 2
Waitlist Available
Research Sponsored by Aurigene Discovery Technologies Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 through follow up visit at week 14

Summary

This trial is testing AUR101, a new medication, in patients with moderate-to-severe plaque psoriasis. The goal is to see if AUR101 can reduce symptoms by targeting inflammation and slowing down skin cell growth.

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 through follow up visit at week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 through follow up visit at week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients achieving PASI 75 response (i.e. 75 percent reduction from baseline PASI [Psoriasis Area and Severity Index] score) at the end of week 12.
Secondary study objectives
Changes in Blood Pressure
Changes in CBC (Complete Blood Count)
Changes in Liver Function Tests
+15 more
Other study objectives
Metabolite of AUR101 identification from plasma collected at week 4
Metabolite of AUR101 identification from urine collected at week 4
Metabolite of AUR101 quantification from plasma collected at week 4
+8 more

Side effects data

From 2021 Phase 2 trial • 90 Patients • NCT04207801
7%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm-1
Arm-2
Arm-3

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: AUR101 400 mg PO QDExperimental Treatment1 Intervention
Patients will receive AUR101 / placebo in double blind, double dummy manner
Group II: AUR101 400 mg PO BIDExperimental Treatment1 Intervention
Patients will receive AUR101 / placebo in double blind, double dummy manner
Group III: AUR101 200 mg PO BIDExperimental Treatment1 Intervention
Patients will receive AUR101 / placebo in double blind, double dummy manner
Group IV: PlaceboPlacebo Group1 Intervention
Patients will receive AUR101 / placebo in double blind, double dummy manner
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AUR101
2020
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Aurigene Discovery Technologies LimitedLead Sponsor
6 Previous Clinical Trials
330 Total Patients Enrolled
Divyesh Mandavia, MDStudy DirectorAurigene Discovery Technologies Limited
~31 spots leftby Dec 2025
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