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A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis

NCT04207801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-08-14

Study results available
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Summary

This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis.

Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the treatment for 12 weeks.

Conditions

  • Chronic Plaque-type Psoriasis

Interventions

DRUG

AUR101

Inhibitor of RORγ

DRUG

Matching Placebo

Drug-Placebo of AUR101 tablet

Sponsors & Collaborators

  • Aurigene Discovery Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Shilendra Pandey, MSc · Aurigene Discovery Techologies Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2021-03-20
Completion
2021-04-15
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207801 on ClinicalTrials.gov