A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)
(INDUS-3 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop using biological agents for psoriasis 3 to 6 months before, non-biological systemic medications 4 weeks before, and medicated topical agents 2 weeks before the study starts.
What safety data exists for the treatment evaluated under names like AUR101 and others?
The safety data for treatments like AUR101 is often derived from randomized controlled trials, which compare the treatment to a placebo (a dummy treatment with no active ingredients). These trials help identify adverse events (unwanted side effects) and their frequency, but reporting on safety is often less detailed than on effectiveness. It's important to look at drug labels and databases like SIDER for detailed side effect information.12345
Research Team
Divyesh Mandavia, MD
Principal Investigator
Aurigene Discovery Technologies Limited
Eligibility Criteria
Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AUR101 or placebo in a double-blind, double-dummy manner for 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AUR101
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aurigene Discovery Technologies Limited
Lead Sponsor