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

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.