A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
Condition: Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: AUR101; Matching Placebo
Intervention description: Inhibitor of RORγ; Drug-Placebo of AUR101 tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: AUR101; Psoriasis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months
             before screening

             2. Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 %
             at screening and Day 1

             3. Adult males or females,≥18 to ≤ 65 years of age.

             4. Ability to communicate well with the investigator and to comply with the
             requirements of the entire study

             5. 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

             2. Efficacy failure on any biologic (e.g. interleukin (IL) -17 antibodies or anti-TNF
             agents) for the treatment of psoriasis.

             3. Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day 1.

             4. BMI ≥ 35 kg/m2

             5. 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

             6. Current treatment or history of treatment for psoriasis with other biological
             agents within 3 months prior to study day 1.

             7. Current treatment or history of treatment for psoriasis with non-biological
             systemic medications or phototherapy within 4 weeks prior to study day 1.

             8. Treatment with medicated topical agents within 2 weeks prior to study day 1.

             9. History or presence of any medical or psychiatric disease, or clinically
             significant laboratory at screening,

             10. Evidence of organ dysfunction

             11. Any major recent surgery history within 3 months prior to screening

             12. Alcohol abuse or drug abuse

             13. History of malignancy

             14. Positive for HIV, Hepatitis B or Hepatitis C at screening.

             15. Patient with known past history of systemic tuberculosis or currently suspected or
             known to have tuberculosis

             16. Patient expected to be started on anti-tubercular therapy either for treatment or
             prophylaxis of tuberculosis.

             17. 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 .

             18. History of hypersensitivity or idiosyncratic reaction to any investigational
             RORgamma inhibitors or any of the excipients of study drug

             19. Past gastrointestinal surgery or recent (within 3 months) / current history of
             gastrointestinal disease.

             20. Positive pregnancy test for women of child bearing potential (WOCBP) at the
             screening or randomization visit

             21. Male patients with partners of childbearing potential not willing to use reliable
             contraception methods.

             22. Pregnant or lactating women or WOCBP who are neither surgically sterilized nor
             willing to use reliable contraceptive methods

             23. Has received another new chemical entity/investigational drug within 28 days or 5
             half-lives of investigational drug prior to study day 1.

             24. Use of herbal remedies, mega dose vitamins and minerals during the 2 weeks prior
             to the first administration of investigational product.

             25. Patients who have received live or attenuated vaccine in the 4 weeks prior to
             study day 1.