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.
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 with moderate-to-severe psoriasis. Approximately 90 patients with chronic moderate-to-severe plaque psoriasis (defined as Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface Area (BSA) involved ≥10%) will be randomized to the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1. The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion. Every patient will receive 12 weeks of treatment. All the patients will be followed up for 14 ± 2 days of their last dose for safety assessment. A subset of approximately 25 patients, who consent, will be asked to come for plasma PK assessment in week 4 of dosing. Efficacy evaluation will be done by PASI, DLQI and BSA assessment. Safety assessment will be done by AEs and regular lab assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Inhibitor of RORγ
Drug-Placebo of AUR101 tablet
B.J Medical College & Civil Hospital
Ahmedabad, Gujarat, India
Kempegowda Institute of Medical Sciences
Bangalore, Karnataka, India
Sapthagiri Hospital
Bangalore, Karnataka, India
Triveni Polyclinic
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline
Time frame: week 12
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline. These secondary measures are measured as Week 4 and Week 8 from the initiation of study drug therapy.
Time frame: Week 4 and Week 8 from study drug initiation for these secondary outcomes measures
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 50 (i.e. 50% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 (i.e. 50% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate baseline and response of therapy in psoriasis. Like PASI 75, the PASI-50 is a binary outcome that indicates a 50% or greater improvement in PASI from baseline. PASI-50 is measured at Week 4, Week 8 and Week 12, as part of this secondary outcome measure.
Time frame: Week 4, Week 8 and Week 12
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Nagpur, Maharashtra, India
Shree Hospital and Critical Care Centre
Nagpur, Maharashtra, India
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, Maharashtra, India
Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, India
Apex Hospitals Private Limited
Jaipur, Rajasthan, India
Life Line Diagnostic Centre Cum Nursing Home
Kolkata, West Bengal, India
Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1
The proportion of patients achieving Investigator Global Assessment (IGA) score of 0 or 1 (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)); The 5-point IGA has a more stringent definition for a score of 1 ("almost clear"); This secondary measure is measured at Week 4, Week 8 and Week 12. The sponsor has represented the proportion in % form by multiplying by 100. The sponsor has done that in CSR (Clinical Study Report) as well
Time frame: Week 4, Week 8 and Week 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. Percent change from baseline in Psoriasis Area and Severity Index (PASI) score. The PASI is a widely used instrument in psoriasis trials that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. It produces a numeric score ranging from 0 to 72. This outcome measures the percentage decrease in PASI from baseline at various pre-specified timepoints
Time frame: week 4,8 and 12
Change From Baseline in Investigator Global Assessment (IGA) Scale
The 5-point IGA has a more stringent definition for a score of 1 ("almost clear") compared with 6-point IGA/Physician's Global Assessment (PGA) tools used in previous trials of other biologics in moderate-to-severe psoriasis. The IGA 0/1 rate is considered robust, demonstrating a strong association with PASI 90. The results for the 5-point IGA are expected to show the same association. This endpoint measures the percent change from baseline in Investigator Global Assessment (IGA) scale (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)) at pre-specified time points.
Time frame: week 4,8 and 12
Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved
BSA assessment measures the total area of the body affected by psoriasis. The body surface area (BSA) of involvement is an important indicator during the evaluation of psoriasis severity. In this secondary outcome measure, the change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involved is measured
Time frame: week 4,8 and 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on their quality of life. The DLQI Scores range from 0 to 30, and higher scores indicate greater health-related quality-of-life impairment. The DLQI questionnaire is divided into 6 commonly identified categories and is rated on a 4-point scale. This secondary outcome measures the change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index (DLQI) score. The minimum value is 0 and maximum is 4
Time frame: Week 4,8 and 12