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

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.

Inclusion criteria

• 1. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening

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

• Adult males or females,≥18 to ≤ 65 years of age.

• Ability to communicate well with the investigator and to comply with the requirements of the entire study

• Willingness to give written informed consent (prior to any study related procedures being performed) and ability to adhere to the study restrictions and assessments schedule.

Exclusion criteria

• 1. History of erythrodermic, guttate, or pustular psoriasis within last 12 months

• Efficacy failure on any biologic (e.g. interleukin (IL) -17 antibodies or anti-TNF agents) for the treatment of psoriasis.

• Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day 1.

• BMI ≥ 35 kg/m2

• Current treatment or history of treatment for psoriasis with IL-17 or IL-12/23 antagonist biological agents within 6 months prior to study day 1

• Current treatment or history of treatment for psoriasis with other biological agents within 3 months prior to study day 1.

• Current treatment or history of treatment for psoriasis with non-biological systemic medications or phototherapy within 4 weeks prior to study day 1.

• Treatment with medicated topical agents within 2 weeks prior to study day 1.

• History or presence of any medical or psychiatric disease, or clinically significant laboratory at screening,

• Evidence of organ dysfunction

• Any major recent surgery history within 3 months prior to screening

• Alcohol abuse or drug abuse

• History of malignancy

• Positive for HIV, Hepatitis B or Hepatitis C at screening.

• Patient with known past history of systemic tuberculosis or currently suspected or known to have tuberculosis

• Patient expected to be started on anti-tubercular therapy either for treatment or prophylaxis of tuberculosis.

• Suspected tuberculosis infection as evident from a positive QuantiFERON TBGold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up as per the opinion of the investigator .

• History of hypersensitivity or idiosyncratic reaction to any investigational RORgamma inhibitors or any of the excipients of study drug

• Past gastrointestinal surgery or recent (within 3 months) / current history of gastrointestinal disease.

• Positive pregnancy test for women of child bearing potential (WOCBP) at the screening or randomization visit

• Male patients with partners of childbearing potential not willing to use reliable contraception methods.

• Pregnant or lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods

• Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug prior to study day 1.

• Use of herbal remedies, mega dose vitamins and minerals during the 2 weeks prior to the first administration of investigational product.

• Patients who have received live or attenuated vaccine in the 4 weeks prior to study day 1.