Chronic Plaque-type Psoriasis
Conditions
Keywords
AUR101, Psoriasis
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.
Interventions
DRUGAUR101
Inhibitor of RORγ
DRUGMatching Placebo
Drug-Placebo of AUR101 tablet
Sponsors
Aurigene Discovery Technologies Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | 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)) | week 12 | 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
| Measure | Time frame | 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)) | Week 4, Week 8 and Week 12 | 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 | Week 4, Week 8 and Week 12 | 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. | week 4,8 and 12 | 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 |
| 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) 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. |
| Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | week 4,8 and 12 | 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) | Week 4,8 and 12 | 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 |
| Change From Baseline in Investigator Global Assessment (IGA) Scale | week 4,8 and 12 | 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. |
Countries
India
Participant flow
Recruitment details
90 patients were enrolled.. Out of these 90, 30 patients each were enrolled in 400 mg PO BID arm, 600 mg BID arm and placebo BID arm.
Participants by arm
| Arm | Count |
|---|---|
| Arm-1 400 mg AUR101 twice daily
AUR101: Inhibitor of RORγ | 30 |
| Arm-2 600 mg AUR101 twice daily
AUR101: Inhibitor of RORγ | 30 |
| Arm-3 Matching Placebo twice daily
Matching Placebo: Drug-Placebo of AUR101 tablet | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Arm-1 | Arm-2 | Arm-3 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 30 Participants | 30 Participants | 30 Participants |
| Age, Continuous | 44.8 years STANDARD_DEVIATION 10.71 | 45.3 years STANDARD_DEVIATION 12.24 | 44.7 years STANDARD_DEVIATION 9.72 | 44.4 years STANDARD_DEVIATION 10.37 |
| Psoriasis Area and Severity Index (PASI) | 25.4 units on a scale STANDARD_DEVIATION 8.97 | 26.1 units on a scale STANDARD_DEVIATION 8.62 | 25.8 units on a scale STANDARD_DEVIATION 10.7 | 24.2 units on a scale STANDARD_DEVIATION 7.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 90 Participants | 30 Participants | 30 Participants | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment India | 90 participants | 30 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 22 Participants | 9 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 68 Participants | 21 Participants | 22 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 3 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 2 / 30 |
Outcome results
Primary
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
Time frame: week 12
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm-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)) | 18 Participants |
| Arm-2 | 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)) | 19 Participants |
| Arm-3 | 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)) | 8 Participants |
Secondary
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
Time frame: Week 4,8 and 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm-1 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 8 | -31.9 Percent change from baseline in DLQI | Standard Deviation 89.83 |
| Arm-1 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 12 | -47.1 Percent change from baseline in DLQI | Standard Deviation 89.45 |
| Arm-1 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 4 | -9.9 Percent change from baseline in DLQI | Standard Deviation 82.47 |
| Arm-2 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 8 | 33.0 Percent change from baseline in DLQI | Standard Deviation 46.9 |
| Arm-2 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 12 | -49.1 Percent change from baseline in DLQI | Standard Deviation 47.53 |
| Arm-2 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 4 | -16.9 Percent change from baseline in DLQI | Standard Deviation 48.94 |
| Arm-3 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 12 | -32.7 Percent change from baseline in DLQI | Standard Deviation 49.46 |
| Arm-3 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 4 | -14.1 Percent change from baseline in DLQI | Standard Deviation 33.16 |
| Arm-3 | Change From Baseline in Dermatology Life Quality Index (DLQI) | Percent Change from Baseline in DLQI score at week 8 | -25.6 Percent change from baseline in DLQI | Standard Deviation 48.36 |
Comparison: Efficacy of AUR101 was tested against placebo with respect to the primary endpoint (PASI75 response). A sample size of 25 in each of the three arms provided an 80% power with a one-sided Type I error of 0.05, if the true placebo response rate was 7% and the response rate on investigational arm(s) was 35%. The sample size was increased to 30 to account for \~ 15-20% dropouts over the study period.p-value: 0.01Fisher Exact
Secondary
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.
Time frame: week 4,8 and 12
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm-1 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 4 | -12.5 % decrease in IGA score | Standard Deviation 18.41 |
| Arm-1 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 8 | -34.2 % decrease in IGA score | Standard Deviation 24.4 |
| Arm-1 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 12 | -50.8 % decrease in IGA score | Standard Deviation 31.74 |
| Arm-2 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 4 | -8.9 % decrease in IGA score | Standard Deviation 15.46 |
| Arm-2 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 12 | -46.9 % decrease in IGA score | Standard Deviation 36.72 |
| Arm-2 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 8 | -24.4 % decrease in IGA score | Standard Deviation 27.15 |
| Arm-3 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 8 | -19.4 % decrease in IGA score | Standard Deviation 19.74 |
| Arm-3 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 12 | -28.9 % decrease in IGA score | Standard Deviation 29.18 |
| Arm-3 | Change From Baseline in Investigator Global Assessment (IGA) Scale | Percent Change from baseline in IGA at week 4 | -3.1 % decrease in IGA score | Standard Deviation 9.41 |
Secondary
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
Time frame: week 4,8 and 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm-1 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA % Change at Week 8 | -35.3 % decrease in BSA (Body Surface Area) | Standard Deviation 30.57 |
| Arm-1 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA% change at Week 12 | -57.6 % decrease in BSA (Body Surface Area) | Standard Deviation 35.03 |
| Arm-1 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA % Change at Week 4 | -8.3 % decrease in BSA (Body Surface Area) | Standard Deviation 19.18 |
| Arm-2 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA % Change at Week 8 | -30.2 % decrease in BSA (Body Surface Area) | Standard Deviation 35.15 |
| Arm-2 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA% change at Week 12 | -56.1 % decrease in BSA (Body Surface Area) | Standard Deviation 39.65 |
| Arm-2 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA % Change at Week 4 | -10.0 % decrease in BSA (Body Surface Area) | Standard Deviation 20.28 |
| Arm-3 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA% change at Week 12 | -29.9 % decrease in BSA (Body Surface Area) | Standard Deviation 34.33 |
| Arm-3 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA % Change at Week 4 | -8.8 % decrease in BSA (Body Surface Area) | Standard Deviation 17.72 |
| Arm-3 | Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved | BSA % Change at Week 8 | -20.4 % decrease in BSA (Body Surface Area) | Standard Deviation 32.89 |
Secondary
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
Time frame: week 4,8 and 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm-1 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week 8 | -52.4 Percent change from baseline in PASI | Standard Deviation 33.68 |
| Arm-1 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week12 | -68.1 Percent change from baseline in PASI | Standard Deviation 33.68 |
| Arm-1 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week 4 | -28.2 Percent change from baseline in PASI | Standard Deviation 27.84 |
| Arm-2 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week 8 | -39.9 Percent change from baseline in PASI | Standard Deviation 39.36 |
| Arm-2 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week12 | -60.3 Percent change from baseline in PASI | Standard Deviation 43.04 |
| Arm-2 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week 4 | -20.4 Percent change from baseline in PASI | Standard Deviation 26.76 |
| Arm-3 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week12 | -43.8 Percent change from baseline in PASI | Standard Deviation 36.19 |
| Arm-3 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week 4 | -15.5 Percent change from baseline in PASI | Standard Deviation 20.35 |
| Arm-3 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score. | Percent Change in PASI at week 8 | -32.6 Percent change from baseline in PASI | Standard Deviation 40.13 |
Secondary
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
Time frame: Week 4, Week 8 and Week 12
Population: ITT (Intention to Treat) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm-1 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 8 | 7 Participants |
| Arm-1 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 12 | 17 Participants |
| Arm-1 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 4 | 0 Participants |
| Arm-2 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 8 | 4 Participants |
| Arm-2 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 12 | 16 Participants |
| Arm-2 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 4 | 0 Participants |
| Arm-3 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 12 | 8 Participants |
| Arm-3 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 4 | 0 Participants |
| Arm-3 | Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1 | IGA Response of 0 or 1 at Week 8 | 2 Participants |
Secondary
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.
Time frame: Week 4, Week 8 and Week 12
Population: PASI-50 at week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm-1 | 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)) | PASI-50 at Week 8 | 16 Participants |
| Arm-1 | 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)) | PASI-50 at Week 12 | 23 Participants |
| Arm-1 | 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)) | PASI-50 at Week 4 | 10 Participants |
| Arm-2 | 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)) | PASI-50 at Week 8 | 13 Participants |
| Arm-2 | 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)) | PASI-50 at Week 12 | 20 Participants |
| Arm-2 | 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)) | PASI-50 at Week 4 | 3 Participants |
| Arm-3 | 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)) | PASI-50 at Week 12 | 14 Participants |
| Arm-3 | 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)) | PASI-50 at Week 4 | 3 Participants |
| Arm-3 | 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)) | PASI-50 at Week 8 | 10 Participants |
Secondary
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.
Time frame: Week 4 and Week 8 from study drug initiation for these secondary outcomes measures
Population: PASI-75 Response at Week 8 for ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm-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)) | PASI-75 Response at Week 8 | 10 Participants |
| Arm-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)) | PASI-75 Response at Week 4 | 1 Participants |
| Arm-2 | 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)) | PASI-75 Response at Week 8 | 4 Participants |
| Arm-2 | 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)) | PASI-75 Response at Week 4 | 1 Participants |
| Arm-3 | 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)) | PASI-75 Response at Week 8 | 5 Participants |
| Arm-3 | 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)) | PASI-75 Response at Week 4 | 0 Participants |