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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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. Static 5-point IGA modified [mod] 2011 scale of 3 or higher at screening and Day 1. 4. Adult males or females, ≥ 18 to ≤ 70 years of age. 5. Ability to communicate well with the investigator and to comply with the requirements of the entire study. 6. 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. BMI < 18 or > 40. 3. 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. 4. 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. 5. 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.
6. 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. 7. 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. 8. 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) 9. Any surgery requiring general anesthesia within 3 months prior to screening. 10. 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. 11. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at screening. 12. Patient with known history of systemic tuberculosis or currently suspected or known to have active tuberculosis. 13. Patient expected to be started on anti-tubercular therapy either for treatment or prophylaxis of tuberculosis. 14. 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. 15. History of hypersensitivity or idiosyncratic reaction to any investigational ROR-gamma inhibitors or any of the excipients of study drug. 16. History of alcohol or substance abuse that will affect compliance to study procedures/schedule as per Investigator opinion. 17. Any previous gastrointestinal surgery or recent (within 3 months) / current history of gastrointestinal disease, that in the opinion of investigator, could impact the absorption of the study drug. 18. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or randomization visit. 19. Male patients who are sexually active with WOCBP, not willing to use reliable contraception methods as mentioned in section 8.14. 20. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap). Please see section 8.14 for acceptable contraceptive practices. 21. Has received any investigational biologic agents within 3 months or 5 half-lives (whichever is longer) prior to the first administration of study drug. 22. Has received another new chemical entity/non-biologic investigational drug within 28 days or 5 half-lives of investigational drug (whichever is longer) prior to study day 1. 23. History of other auto-immune disorders (except psoriasis and psoriatic arthritis) where treatment with systemic immunosuppressants is required. 24. History of active infection and/or febrile illness within 7 days prior to Day 1. The infection adequately treated by antibiotics during the screening period as per investigator opinion will be allowed to undergo randomization, provided patient is stable for at least 7 days before randomization. 25. Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Day 1. 26. History or presence of any major medical illness (e.g. renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness) or psychiatric disease, or clinically significant laboratory / ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study. 27. History of any unstable cardiac (including Class III or IV congestive heart failure by New York Heart Association Criteria), respiratory, hepatic, renal or other systemic conditions within 3 months prior to first study drug administration. 28. Use of herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of study drug. 29. Patients who have received live attenuated vaccine in the 4 weeks prior to the first administration of study drug -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04855721
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aurigene Discovery Technologies Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Divyesh Mandavia, MD
Principal Investigator Affiliation Aurigene Discovery Technologies Limited
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate the efficacy and safety of AUR101 in patients with moderate-to-severe psoriasis. Approximately 128 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 four groups (three dose groups of AUR101 and one placebo group) in the ratio of 1:1:1:1. The patients in each arm will receive AUR101 of 200 mg twice daily, 400 mg twice daily, 400 mg once daily or matching placebo for 12 weeks in a double blind, double dummy fashion. All patients will be followed up for 14 ± 2 days of their last dose for safety assessment.

Arms & Interventions

Arms

Experimental: AUR101 400 mg PO BID

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

Experimental: AUR101 200 mg PO BID

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

Experimental: AUR101 400 mg PO QD

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

Placebo Comparator: Placebo

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

Interventions

Drug: - AUR101

Oral ROR-gamma inverse agonist

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johnson Dermatology, Fort Smith, Arkansas

Status

Recruiting

Address

Johnson Dermatology

Fort Smith, Arkansas, 72916

Site Contact

Sandra Johnson, MD

[email protected]

+919873554523

First OC Dermatology, Fountain Valley, California

Status

Recruiting

Address

First OC Dermatology

Fountain Valley, California, 92708

Site Contact

Vivian Laquer, MD

[email protected]

+919873554523

University Clinical Trials, Inc., San Diego, California

Status

Not yet recruiting

Address

University Clinical Trials, Inc.

San Diego, California, 92123

Site Contact

Walter Nahm, MD

[email protected]

+919873554523

Unison Clinical Trials, Sherman Oaks, California

Status

Recruiting

Address

Unison Clinical Trials

Sherman Oaks, California, 91403

Site Contact

Shahram Jacobs, MD

[email protected]

+919873554523

Direct Helpers Research Center, Hialeah, Florida

Status

Recruiting

Address

Direct Helpers Research Center

Hialeah, Florida, 33012

Site Contact

Frank Don, DO

[email protected]

+919873554523

FXM Clinical Research Miami LLC, Miami, Florida

Status

Recruiting

Address

FXM Clinical Research Miami LLC

Miami, Florida, 33175

Site Contact

Hector Wiltz, MD

[email protected]

+919873554523

FXM Clinical Research Miramar LLC, Miramar, Florida

Status

Recruiting

Address

FXM Clinical Research Miramar LLC

Miramar, Florida, 33027

Site Contact

Francisco Flores, MD

[email protected]

+919873554523

Lenus Research & Medical Group, LLC, Sweetwater, Florida

Status

Recruiting

Address

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172

Site Contact

John Niven, MD

[email protected]

+919873554523

Great Lakes Research Group, Inc, Bay City, Michigan

Status

Not yet recruiting

Address

Great Lakes Research Group, Inc

Bay City, Michigan, 48706

Site Contact

Brent Boyce, MD

[email protected]

+919873554523

The Dermatology Specialists, New York, New York

Status

Not yet recruiting

Address

The Dermatology Specialists

New York, New York, 10012

Site Contact

Andrew Peranteau, MD

[email protected]

+919873554523

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