A Phase II, Multicenter, Double-blind, Double-dummy, Placebo Controlled, Randomized, Study to Evaluate the Efficacy and Safety of Two Doses of AUR101 in Patients With Moderate-to-Severe Psoriasis
A Phase II, Multicenter, Double-blind, Double-dummy, Placebo Controlled, Randomized, Study to Evaluate the Efficacy and Safety of Two Doses of AUR101 in Patients With Moderate-to-Severe Psoriasis
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.
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.
Nagpur, Maharashtra 440019, India