AUR101 for Plaque Psoriasis

(INDUS-3 Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AUR101 to evaluate its effectiveness and safety for individuals with moderate-to-severe psoriasis, a skin condition causing red, scaly patches. Participants will receive either AUR101 or a placebo (a substance with no active treatment) to compare effects. Ideal candidates have been diagnosed with plaque-type psoriasis for at least 6 months and experience significant symptoms impacting daily life. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AUR101 has been safe in early studies. In one study with healthy volunteers, AUR101 was safe and well-tolerated, with no major side effects reported, which is encouraging. Another study tested AUR101 in patients and also focused on safety. The results showed that AUR101 was generally well-tolerated. These findings suggest that AUR101 may be safe for humans, but more studies are needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Researchers are excited about AUR101 for psoriasis because it offers a new approach to tackling the condition. Most current treatments for psoriasis, like biologics and topical corticosteroids, target inflammation or immune response pathways. AUR101, however, works by inhibiting a specific enzyme involved in the inflammation process, potentially leading to more targeted and effective treatment. This could mean fewer side effects and improved outcomes for patients. Additionally, AUR101 is administered orally, which might be more convenient for patients compared to injections or topical treatments.

What evidence suggests that AUR101 might be an effective treatment for psoriasis?

Research shows that AUR101 may help treat psoriasis by blocking a protein called IL-17A, which plays a role in the inflammation associated with the condition. Previous studies with participants demonstrated that AUR101 can effectively reduce this inflammation. Early research also suggests that AUR101 has strong potential as a treatment. The body absorbs and processes it well, allowing it to work effectively. This trial will evaluate different dosages of AUR101, and the evidence supports the potential of AUR101 to help manage moderate-to-severe psoriasis. ^{1 3 6 7 8}

Who Is on the Research Team?

Divyesh Mandavia, MD

Principal Investigator

Aurigene Discovery Technologies Limited

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• AUR101
• Placebo

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04207801

NCT04207801 | A Phase II Study to Evaluate Efficacy & ...

This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of two doses of AUR101 in patients ...

2.

auralysbiotech.com

auralysbiotech.com/promising-preclinical-data-for-aur-101-presented-at-biotechx-europe-2025/

Promising Preclinical Data for AUR-101 Presented at ...

The data highlighted the strong therapeutic potential of AUR-101, a first-in-class compound designed using Auralys' proprietary AI-driven ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04855721?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Aurigene%20Discovery%20Technologies%20Limited%22)&viewType=Table&rank=10

A Dose-Ranging Phase II Study of AUR101 in Psoriasis ...

This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate the efficacy and safety of AUR101 in patients with ...

4.

ctv.veeva.com

ctv.veeva.com/study/a-phase-ii-study-to-evaluate-efficacy-safety-of-aur101-in-patients-of-moderate-to-severe-psoriasis

A Phase II Study to Evaluate Efficacy & Safety of AUR101 in ...

This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 ...

5.

indianpharmapost.com

indianpharmapost.com/news/aurigene-reports-results-of-aur101-in-phase-ii-study-in-us-patients-13465

Aurigene reports results of AUR101 in phase II study in US ...

AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients.

6.

aurigene.com

aurigene.com/publications/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-aur101-an-ror%CE%B3t-inhibitor-in-normal-healthy-volunteers-2/

Safety, tolerability, pharmacokinetics and ...

Safety, tolerability, pharmacokinetics and pharmacodynamics of AUR101, An RORγt inhibitor, in normal healthy volunteers.

7.

jaad.org

jaad.org/article/S0190-9622(21)01666-2/abstract

27346 Efficacy and safety from a phase II study of AUR101, ...

A Phase I study among healthy volunteers has shown acceptable safety and IL-17 inhibition with AUR101.

8.

withpower.com

withpower.com/trial/phase-3-psoriasis-4-2021-f56fa

A Dose-Ranging Phase II Study of AUR101 in Psoriasis ...

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 ...