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

Study Purpose

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.

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 - 65 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. 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.

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.

NCT04207801
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.

Shilendra Pandey, MSc
Principal Investigator Affiliation Aurigene Discovery Techologies Limited
Agency Class

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

Industry
Overall Status Recruiting
Countries India
Conditions

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

Chronic Plaque-type Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Arm-1

400 mg AUR101 twice daily

Experimental: Arm-2

600 mg AUR101 twice daily

Placebo Comparator: Arm-3

Matching Placebo twice daily

Interventions

Drug: - AUR101

Inhibitor of RORγ

Drug: - Matching Placebo

Drug-Placebo of AUR101 tablet

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.

International Sites

Govt. General Hospital & Medical College, Srikakulam, Andhra Pradesh, India

Status

Not yet recruiting

Address

Govt. General Hospital & Medical College

Srikakulam, Andhra Pradesh, 532001

Site Contact

Kanaka Prasad Rao M, MD

[email protected]

+919948741133

B.J Medical College & Civil Hospital, Ahmedabad, Gujarat, India

Status

Recruiting

Address

B.J Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016

Site Contact

Dr Bela Shah, MD

[email protected]

+919898059289

Kempegowda Institute of Medical Sciences, Bangalore, Karnataka, India

Status

Recruiting

Address

Kempegowda Institute of Medical Sciences

Bangalore, Karnataka, 560004

Site Contact

Dr. Nandini A S, MD

[email protected]

+919886829579

Sapthagiri Hospital, Bangalore, Karnataka, India

Status

Recruiting

Address

Sapthagiri Hospital

Bangalore, Karnataka, 560090

Site Contact

Dr Savitha A S, MD

[email protected]

+919880512166

Amrita Institute of Medical Science, Kochi, Kerala, India

Status

Not yet recruiting

Address

Amrita Institute of Medical Science

Kochi, Kerala, 682041

Site Contact

Dr. Vinitha Varghese Panicker, MD, MBBS

[email protected]

9847179964

Grant Medical college and JJ Hospital, Mumbai, Maharashtra, India

Status

Not yet recruiting

Address

Grant Medical college and JJ Hospital

Mumbai, Maharashtra, 400008

Site Contact

Dr Mahendra Kura, MD

[email protected]

+919322593511

Triveni Polyclinic, Nagpur, Maharashtra, India

Status

Recruiting

Address

Triveni Polyclinic

Nagpur, Maharashtra, 440008

Site Contact

Dr. Ashutosh Mehata, MD, MBBS

[email protected]

9881873985

Shree Hospital and Critical Care Centre, Nagpur, Maharashtra, India

Status

Recruiting

Address

Shree Hospital and Critical Care Centre

Nagpur, Maharashtra, 440009

Site Contact

Dr Shyamal Balki, MD

[email protected]

+919665477444

Nagpur, Maharashtra, India

Status

Recruiting

Address

NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

Nagpur, Maharashtra, 440019

Site Contact

Dr Sushil Pande, MD

[email protected]

+919323511245

Nashik, Maharashtra, India

Status

Recruiting

Address

Sujata Birla Hospital & Medical Research Center

Nashik, Maharashtra, 422101

Site Contact

Dr Suneel Vartak, MD

[email protected]

+919373901829

Apex Hospitals Private Limited, Jaipur, Rajasthan, India

Status

Recruiting

Address

Apex Hospitals Private Limited

Jaipur, Rajasthan, 302017

Site Contact

Dr. Neetu Sidana, MD, MBBS

[email protected]

9314661504

Calcutta National Medical College, Kolkata, West Bengal, India

Status

Not yet recruiting

Address

Calcutta National Medical College

Kolkata, West Bengal, 700014

Site Contact

Dr Abhisekh De, MD

[email protected]

+919903275551

Kolkata, West Bengal, India

Status

Not yet recruiting

Address

Life Line Diagnostic Centre Cum Nursing Home

Kolkata, West Bengal, 700016

Site Contact

Dr. Ishad Aggarwal, MD, MBBS

[email protected]

8100622846

Kolkata, West Bengal, India

Status

Not yet recruiting

Address

College of Medicine and Sagore Dutta Hospital

Kolkata, West Bengal, 700055

Site Contact

Dr. Indrashis Podder, MD, MBBS

[email protected]

9007977161

Medical College and Hospital, Kolkata, West Bengal, India

Status

Not yet recruiting

Address

Medical College and Hospital

Kolkata, West Bengal, 700073

Site Contact

Dr Abanti saha, MD

[email protected]

+919432146692

Chandigarh, India

Status

Not yet recruiting

Address

Postgraduate Institute of Medical Education & Research

Chandigarh, , 160 012

Site Contact

Dr Sunil Dogra, MD

[email protected]

+919855005941

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