Clinical trial NCT04207801: A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque-type Psoriasis
Keywords: AUR101
Psoriasis
Lead sponsor: Aurigene Discovery Technologies Limited
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: 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))
timeFrame: week 12
Secondary outcomes:
measure: 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))
timeFrame: Week 4 and Week 8 from study drug initiation for these secondary outcomes measures
measure: 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))
timeFrame: Week 4, Week 8 and Week 12
measure: Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1
timeFrame: Week 4, Week 8 and Week 12
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
timeFrame: week 4,8 and 12
measure: Change From Baseline in Investigator Global Assessment (IGA) Scale
timeFrame: week 4,8 and 12
measure: Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved
timeFrame: week 4,8 and 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Week 4,8 and 12
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: B.J Medical College & Civil Hospital
state: Gujarat
city: Bangalore
country: India
facility: Kempegowda Institute of Medical Sciences
state: Karnataka
city: Bangalore
country: India
facility: Sapthagiri Hospital
state: Karnataka
city: Nagpur
country: India
facility: Triveni Polyclinic
state: Maharashtra
city: Nagpur
country: India
facility: Shree Hospital and Critical Care Centre
state: Maharashtra
city: Nagpur
country: India
facility: NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
state: Maharashtra
city: Nashik
country: India
facility: Sujata Birla Hospital & Medical Research Center
state: Maharashtra
city: Jaipur
country: India
facility: Apex Hospitals Private Limited
state: Rajasthan
city: Kolkata
country: India
facility: Life Line Diagnostic Centre Cum Nursing Home
state: West Bengal
Study officials:
affiliation: Aurigene Discovery Techologies Limited
name: Shilendra Pandey, MSc
role: STUDY_CHAIR
References: