A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)

NCT04855721 | Completed Phase 2 FDA Drug

• 1 other identifier: AUR101-202
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 25

Brief Summary

A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized Study to Evaluate the Efficacy and Safety of AUR101 in patients with Moderate-to-Severe Psoriasis (INDUS-3)

Conditions

Plaque Psoriasis

Keywords

psoriasis; AUR101; ROR; RORgamma; RORgamma inverse agonist; RORgamma inhibitor

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving PASI 75 response (i.e. 75 percent reduction from baseline PASI [Psoriasis Area and Severity Index] score) at the end of week 12.

  PASI-75; A higher proportion of patients reaching PASI-75 means betterment in higher proportion of patients

  Week 12

Secondary Outcomes (19)

• Proportion of patients achieving PASI 75 response (i.e. 75 percent reduction from baseline PASI [Psoriasis Area and Severity Index] score) at the end of week 4 and 8

  Week 4 and Week 8

• Proportion of patients achieving PASI 50, PASI 90 and PASI 100 response at week 12.

  Week 12

• Proportion of patients achieving IGA 0 or 1 at week 12

  Week 12

• Percent change from baseline in PASI score at week 12

  Week 12

• Percent change from baseline to week 12 in percent BSA involved

  Week 12

Other Outcomes (11)

• Metabolite of AUR101 identification from plasma collected at week 4

  Week 4

• Metabolite of AUR101 quantification from plasma collected at week 4

  Week 4

• Metabolite of AUR101 identification from urine collected at week 4

  Week 4

Study Arms (4)

AUR101 400 mg PO BID

EXPERIMENTAL

Patients will receive AUR101 / placebo in double blind, double dummy manner

Drug: AUR101

AUR101 200 mg PO BID

EXPERIMENTAL

Patients will receive AUR101 / placebo in double blind, double dummy manner

Drug: AUR101

AUR101 400 mg PO QD

EXPERIMENTAL

Patients will receive AUR101 / placebo in double blind, double dummy manner

Drug: AUR101

Placebo

PLACEBO COMPARATOR

Patients will receive AUR101 / placebo in double blind, double dummy manner

Drug: Placebo

Interventions

AUR101 DRUG

Oral ROR-gamma inverse agonist

AUR101 200 mg PO BID; AUR101 400 mg PO BID; AUR101 400 mg PO QD

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 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
• Static 5-point IGA modified \[mod\] 2011 scale of 3 or higher at screening and Day 1
• Adult males or females, ≥ 18 to ≤ 70 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
• BMI \< 18 or \> 40
• History of lack of response to ustekinumab, secukinumab or ixekizumab (or any therapeutic agent targeted to IL12, IL-17 or IL-23) at approved doses after at least 3 months of therapy
• Current treatment or history of treatment for psoriasis with any investigational or approved IL-17, IL-12 or IL-23 antagonist biological agents (e.g. secukinumab, briakinumab, tildrakizumab, ustekinumab etc.) within 6 months prior to the first administration of study drug.
• Current treatment or history of treatment for psoriasis with other investigational or approved biological agents (e.g. anti-TNFα inhibitors - adalimumab, etanercept, infliximab, alefacept etc.) within 3 months prior to the first administration of study drug
• Current treatment or history of treatment for psoriasis with non-biological systemic medications or immunomodulators (including systemic steroids, apremilast, methotrexate, cyclosporine, acitretin, etc.) or phototherapy within 4 weeks prior to the first administration of study drug.
• Treatment with medicated topical agents (having active pharmaceutical ingredient that can impact or interfere with the effect of the study drug) within 2 weeks prior to the first administration of study drug.
• Evidence of organ dysfunction (e.g. liver dysfunction ≥ 1.5 X of ULN for ALT, AST or ALP or Total Bilirubin, or renal dysfunction of ≥ 1.5X of ULN of serum creatinine)
• Any surgery requiring general anesthesia within 3 months prior to screening
• History of malignancy within last 5 years except patients with non-melanoma skin cancer or carcinoma in situ of cervix who can participate in the study. Adequately treated cutaneous basal or squamous cell carcinoma are allowed.
• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at screening
• Patient with known history of systemic tuberculosis or currently suspected or known to have active 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 TB-Gold test (QFT) or Mantoux test (MT) at screening. Patients with a positive QFT or MT may participate in the study if further work up as per the opinion of the investigator (like Chest X-ray or CT scan of Chest or other locally acceptable method for diagnosing active tuberculosis) establishes that patient does not have active tuberculosis. Patients with latent tuberculosis should not be enrolled except when they are not planned to start prophylaxis for tuberculosis during the study period.
• History of hypersensitivity or idiosyncratic reaction to any investigational ROR-gamma inhibitors or any of the excipients of study drug

Sponsors & Collaborators

• Aurigene Discovery Technologies Limited: lead

Study Sites (25)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Northwest AR Clinical Trials Center

Rogers, Arkansas, 72758, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Moore Clinical Research, Inc.

Brandon, Florida, 33511, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

Accel Research Sites - Deland CRU

DeLand, Florida, 32720, United States

Location

FXM Clinical Research Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Abys New Generation Research Inc.

Hialeah, Florida, 33016, United States

Location

FXM Clinical Research Miami LLC

Miami, Florida, 33175, United States

Location

Floridian Reserach

Miami, Florida, 33179, United States

Location

FXM Clinical Research Miramar LLC

Miramar, Florida, 33027, United States

Location

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Great Lakes Research Group, Inc

Bay City, Michigan, 48706, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

The Dermatology Specialists

New York, New York, 10012, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Paddington Testing Co, Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Dermatology Treatment & Research Center

Dallas, Texas, 75230, United States

Location

Center for Clinical Studies Ltd., LLP.

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Divyesh Mandavia, MD

  Aurigene Discovery Technologies Limited

  STUDY DIRECTOR

Study Design

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

Model Details: There are 4 groups in the study; 1 with placebo and 3 with different AUR101 dosing regimens

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 22, 2021
• Study Start: May 4, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 10, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)