Back to resultsA Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis (INDUS-2)
Primary Purpose
Chronic Plaque-type Psoriasis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
AUR101
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque-type Psoriasis focused on measuring AUR101, Psoriasis
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.
Sites / Locations
- B.J Medical College & Civil Hospital
- Kempegowda Institute of Medical Sciences
- Sapthagiri Hospital
- Triveni Polyclinic
- Shree Hospital and Critical Care Centre
- NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
- Sujata Birla Hospital & Medical Research Center
- Apex Hospitals Private Limited
- Life Line Diagnostic Centre Cum Nursing Home
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm-1 400 mg BID
Arm-2 600 mg BID
Arm-3 - Matching Placebo BID
Arm Description
400 mg AUR101 twice daily
600 mg AUR101 twice daily
Matching Placebo twice daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline. These secondary measures are measured as Week 4 and Week 8 from the initiation of study drug therapy.
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))
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)); The PASI is a scoring system to evaluate baseline and response of therapy in psoriasis. Like PASI 75, the PASI-50 is a binary outcome that indicates a 50% or greater improvement in PASI from baseline. PASI-50 is measured at Week 4, Week 8 and Week 12, as part of this secondary outcome measure.
Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1
The proportion of patients achieving Investigator Global Assessment (IGA) score of 0 or 1 (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)); The 5-point IGA has a more stringent definition for a score of 1 ("almost clear"); This secondary measure is measured at Week 4, Week 8 and Week 12. The sponsor has represented the proportion in % form by multiplying by 100. The sponsor has done that in CSR (Clinical Study Report) as well
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. Percent change from baseline in Psoriasis Area and Severity Index (PASI) score. The PASI is a widely used instrument in psoriasis trials that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. It produces a numeric score ranging from 0 to 72. This outcome measures the percentage decrease in PASI from baseline at various pre-specified timepoints
Change From Baseline in Investigator Global Assessment (IGA) Scale
The 5-point IGA has a more stringent definition for a score of 1 ("almost clear") compared with 6-point IGA/Physician's Global Assessment (PGA) tools used in previous trials of other biologics in moderate-to-severe psoriasis. The IGA 0/1 rate is considered robust, demonstrating a strong association with PASI 90. The results for the 5-point IGA are expected to show the same association. This endpoint measures the percent change from baseline in Investigator Global Assessment (IGA) scale (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)) at pre-specified time points.
Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved
BSA assessment measures the total area of the body affected by psoriasis. The body surface area (BSA) of involvement is an important indicator during the evaluation of psoriasis severity. In this secondary outcome measure, the change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involved is measured
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on their quality of life. The DLQI Scores range from 0 to 30, and higher scores indicate greater health-related quality-of-life impairment.
The DLQI questionnaire is divided into 6 commonly identified categories and is rated on a 4-point scale. This secondary outcome measures the change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index (DLQI) score. The minimum value is 0 and maximum is 4
Full Information
NCT ID
NCT04207801
First Posted
December 19, 2019
Last Updated
July 20, 2023
Sponsor
Aurigene Discovery Technologies Limited
1. Study Identification
Unique Protocol Identification Number
NCT04207801
Brief Title
A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
Acronym
INDUS-2
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurigene Discovery Technologies Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque-type Psoriasis
Keywords
AUR101, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm-1 400 mg BID
Arm Type
Experimental
Arm Description
400 mg AUR101 twice daily
Arm Title
Arm-2 600 mg BID
Arm Type
Experimental
Arm Description
600 mg AUR101 twice daily
Arm Title
Arm-3 - Matching Placebo BID
Arm Type
Placebo Comparator
Arm Description
Matching Placebo twice daily
Intervention Type
Drug
Intervention Name(s)
AUR101
Other Intervention Name(s)
No other names
Intervention Description
Inhibitor of RORγ
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
No other names
Intervention Description
Drug-Placebo of AUR101 tablet
Primary Outcome Measure Information:
Title
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))
Description
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
Time Frame
week 12
Secondary Outcome Measure Information:
Title
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))
Description
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. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline. These secondary measures are measured as Week 4 and Week 8 from the initiation of study drug therapy.
Time Frame
Week 4 and Week 8 from study drug initiation for these secondary outcomes measures
Title
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))
Description
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)); The PASI is a scoring system to evaluate baseline and response of therapy in psoriasis. Like PASI 75, the PASI-50 is a binary outcome that indicates a 50% or greater improvement in PASI from baseline. PASI-50 is measured at Week 4, Week 8 and Week 12, as part of this secondary outcome measure.
Time Frame
Week 4, Week 8 and Week 12
Title
Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1
Description
The proportion of patients achieving Investigator Global Assessment (IGA) score of 0 or 1 (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)); The 5-point IGA has a more stringent definition for a score of 1 ("almost clear"); This secondary measure is measured at Week 4, Week 8 and Week 12. The sponsor has represented the proportion in % form by multiplying by 100. The sponsor has done that in CSR (Clinical Study Report) as well
Time Frame
Week 4, Week 8 and Week 12
Title
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
Description
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. Percent change from baseline in Psoriasis Area and Severity Index (PASI) score. The PASI is a widely used instrument in psoriasis trials that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. It produces a numeric score ranging from 0 to 72. This outcome measures the percentage decrease in PASI from baseline at various pre-specified timepoints
Time Frame
week 4,8 and 12
Title
Change From Baseline in Investigator Global Assessment (IGA) Scale
Description
The 5-point IGA has a more stringent definition for a score of 1 ("almost clear") compared with 6-point IGA/Physician's Global Assessment (PGA) tools used in previous trials of other biologics in moderate-to-severe psoriasis. The IGA 0/1 rate is considered robust, demonstrating a strong association with PASI 90. The results for the 5-point IGA are expected to show the same association. This endpoint measures the percent change from baseline in Investigator Global Assessment (IGA) scale (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)) at pre-specified time points.
Time Frame
week 4,8 and 12
Title
Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved
Description
BSA assessment measures the total area of the body affected by psoriasis. The body surface area (BSA) of involvement is an important indicator during the evaluation of psoriasis severity. In this secondary outcome measure, the change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involved is measured
Time Frame
week 4,8 and 12
Title
Change From Baseline in Dermatology Life Quality Index (DLQI)
Description
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on their quality of life. The DLQI Scores range from 0 to 30, and higher scores indicate greater health-related quality-of-life impairment.
The DLQI questionnaire is divided into 6 commonly identified categories and is rated on a 4-point scale. This secondary outcome measures the change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index (DLQI) score. The minimum value is 0 and maximum is 4
Time Frame
Week 4,8 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shilendra Pandey, MSc
Organizational Affiliation
Aurigene Discovery Techologies Limited
Official's Role
Study Chair
Facility Information:
Facility Name
B.J Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Kempegowda Institute of Medical Sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560004
Country
India
Facility Name
Sapthagiri Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560090
Country
India
Facility Name
Triveni Polyclinic
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440008
Country
India
Facility Name
Shree Hospital and Critical Care Centre
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440009
Country
India
Facility Name
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440019
Country
India
Facility Name
Sujata Birla Hospital & Medical Research Center
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Facility Name
Apex Hospitals Private Limited
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Life Line Diagnostic Centre Cum Nursing Home
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700016
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not yet planned to share
Learn more about this trial
A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
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