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

NCT04207801 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AUR101-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Plaque-type Psoriasis

Keywords

AUR101; Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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))

  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)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline

  week 12

Secondary Outcomes (7)

• 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))

  Week 4 and Week 8 from study drug initiation for these secondary outcomes measures

• 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))

  Week 4, Week 8 and Week 12

• Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1

  Week 4, Week 8 and Week 12

• Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.

  week 4,8 and 12

• Change From Baseline in Investigator Global Assessment (IGA) Scale

  week 4,8 and 12

Study Arms (3)

Arm-1 400 mg BID

EXPERIMENTAL

400 mg AUR101 twice daily

Drug: AUR101

Arm-2 600 mg BID

EXPERIMENTAL

600 mg AUR101 twice daily

Drug: AUR101

Arm-3 - Matching Placebo BID

PLACEBO COMPARATOR

Matching Placebo twice daily

Drug: Matching Placebo

Interventions

AUR101 DRUG

Inhibitor of RORγ

Also known as: No other names

Arm-1 400 mg BID; Arm-2 600 mg BID

Matching Placebo DRUG

Drug-Placebo of AUR101 tablet

Also known as: No other names

Arm-3 - Matching Placebo BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (9)

B.J Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016, India

Location

Kempegowda Institute of Medical Sciences

Bangalore, Karnataka, 560004, India

Location

Sapthagiri Hospital

Bangalore, Karnataka, 560090, India

Location

Triveni Polyclinic

Nagpur, Maharashtra, 440008, India

Location

Shree Hospital and Critical Care Centre

Nagpur, Maharashtra, 440009, India

Location

NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

Nagpur, Maharashtra, 440019, India

Location

Sujata Birla Hospital & Medical Research Center

Nashik, Maharashtra, 422101, India

Location

Apex Hospitals Private Limited

Jaipur, Rajasthan, 302017, India

Location

Life Line Diagnostic Centre Cum Nursing Home

Kolkata, West Bengal, 700016, India

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Divyesh Mandavia
• Organization: Aurigene Discovery Technologies Limited

divyesh_m@aurigene.com

9427181182

Study Officials

• Shilendra Pandey, MSc

  Aurigene Discovery Techologies Limited

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 21, 2020
• Primary Completion: March 20, 2021
• Study Completion: April 15, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9)