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AUR101 for Plaque Psoriasis (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
Awards & highlights

INDUS-3 Trial Summary

This trial is testing a new drug, AUR101, for people with moderate to severe psoriasis. It is double-blind, meaning neither the patients nor the researchers will know who is receiving the drug or the placebo.

Eligible Conditions
  • Plaque Psoriasis

INDUS-3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Changes in Blood Pressure
Changes in CBC (Complete Blood Count)
Changes in Liver Function Tests
+15 more
Other outcome measures
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

INDUS-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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has AUR101 been granted approval by the U.S. Food and Drug Administration?

"Our team at Power has rated the safety of AUR101 as a 2, given that this is a Phase 2 trial. This signifies some data supporting its security but none to vouch for efficacy."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"The criteria for enrolment in this trial entails that applicants possess psoriasis vulgaris (plaque psoriasis) and are between 18 to 70 years old. Approximately 141 lucky individuals will be selected."

Answered by AI

What is the geographical scope of this trial's implementation?

"This research is enrolling participants at 25 different medical sites, with notable locations being University Clinical Trials in San Diego, Skin Research Institute in Coral Gables and FXM Clinical Research Miami LLC."

Answered by AI

Are there any opportunities for individuals to sign up as participants in this experiment?

"As displayed on the clinicaltrials.gov web page, this medical experiment has ceased to recruit participants since its last update in August 2022 - however, 167 other trials are actively recruiting volunteers at present."

Answered by AI

Does this experimental protocol accept volunteers aged 65 or older?

"This trial looks for participants aged between 18 and 70 years old. There are 31 clinical trials that accept minors while 142 studies are dedicated to those above 65."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)
2021. "A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855721.
~36 spots leftby Apr 2025
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