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

(INDUS-3 Trial)

Recruiting at 24 trial locations

Overseen By Ravitej Ramachandran, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aurigene Discovery Technologies Limited

Must not be taking: Biologics, Immunomodulators

Disqualifiers: Tuberculosis, HIV, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

141 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Divyesh Mandavia, MD

Principal Investigator

Aurigene Discovery Technologies Limited

Eligibility Criteria

Inclusion Criteria

You are able to communicate well with the investigator and to comply with the requirements of the entire study.

Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1

You have chronic plaque-type psoriasis, diagnosed at least 6 months before screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AUR101 or placebo in a double-blind, double-dummy manner for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• AUR101
• Placebo

Participant Groups

Group I: AUR101 400 mg PO QD Experimental Treatment 1 Intervention

Patients will receive AUR101 / placebo in double blind, double dummy manner

Group II: AUR101 400 mg PO BID Experimental Treatment 1 Intervention

Patients will receive AUR101 / placebo in double blind, double dummy manner

Group III: AUR101 200 mg PO BID Experimental Treatment 1 Intervention

Patients will receive AUR101 / placebo in double blind, double dummy manner

Group IV: Placebo Placebo Group 1 Intervention

Patients will receive AUR101 / placebo in double blind, double dummy manner

Who Is Running the Clinical Trial?

Aurigene Discovery Technologies Limited

Lead Sponsor

Trials

10

Recruited

640+

Findings from Research

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

The review of clinical research data from 1977 to 2011 highlights significant inconsistencies in how adverse reactions (AR) to drugs are assessed, which can affect the reliability of safety information provided to patients.

To improve the safety profiles of medications, the authors advocate for the establishment of a common European standard for the structured assessment of adverse reactions in clinical research, as no such standard currently exists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessing adverse reactions in clinical trials]. Harnisch, S., Schade-Brittinger, C., Rief, W.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Event Burden Score-A Versatile Summary Measure for Cancer Clinical Trials. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The SIDER database of drugs and side effects. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

[Assessing adverse reactions in clinical trials]. [2013]