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This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AS012 dose regimen I | Experimental | Oral |
|
| AS012 dose regimen II | Experimental | Oral |
|
| AS012 dose regimen III | Experimental | Oral |
|
| AS012 dose regimen IV | Experimental | Oral |
|
| Placebo | Placebo Comparator | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS012 | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Vitiligo Area Scoring Index Score | Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures | The Vitiligo Extent Score (VES) measures the overall vitiligo involvement in the body based on clinical pictures reflecting the natural distribution of the disease across 19 body areas (e.g., face, trunk, arms, legs, hands, axillae, back, gluteal). For each area, one representative image is selected, assigning one of six degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%). The total and final score is the sum of the measurements from all areas, calculated using a conversion table available in the online calculator (www.vitiligo-calculator.com), and expressed as the extension of body surface area affected (0-100). Higher scores indicate worse clinical involvement. The VES change from baseline to Week 24 was assessed for the ITT population. |
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Inclusion Criteria:
Exclusion Criteria:
Segmental vitiligo, focal, or mixed Vitiligo
Subjects who have high risk of suicidality at the Screening assessment based on Investigator's judgment
History of alcohol or drug abuse in the previous 2 years
Subjects who were submitted to melanocyte transfer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Pharma Site 15 | Phoenix | Arizona | 85018 | United States | ||
| Sun Pharma Site 02 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Part I: Up to 24 weeks: Subjects were randomized to Placebo Part II: week 24 to week 52: No Subjects Part III: week 52 to week 64: No Subjects |
| FG001 | Placebo to AS012 Dose Regimen II at Week 24 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2022 | Oct 9, 2024 |
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| Placebo | Drug | oral administration |
|
| Week 24 |
| Mean Change in Vitiligo Impact Patient Scale | Subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. For each of the statements in the Vitiligo Impact Patient Scale, 7 responses are suggested: always, very often, often, sometimes, rarely, never and not applicable. The individual answered as spontaneously as possible while thinking about their situation over the last 7 days. Summary scores range from 0 to 100. Higher values indicate a worse clinical condition. | Week 24 |
| Physician's Global Assessment Scores | Description: The investigator will perform an average assessment of all vitiligo lesions. The following scale will be used for the PGA: Score 0= No involvement, Score 1= Limited, Score 2= moderate, Score 3= Extensive or Score 4= Very extensive. Higher values indicate a worse clinical condition. The static Physician's Global Assessment determines vitiligo extend at a single point in time, without taking the baseline disease condition into consideration, in other words, represents the Proportion of subjects achieving a PGA score of "no involvement" (score 0) or "limited extent" (score 1) with at least 2-point reduction from Baseline Week 52. | Week 52 |
| Mean Change From Baseline in Dermatology Life Quality Index | The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life. | Week 52 |
| Bryant |
| Arkansas |
| 72022 |
| United States |
| Sun Pharma Site 09 | Fremont | California | 94538 | United States |
| Sun pharma site 30 | Los Angeles | California | 90036 | United States |
| Sun Pharma Site 01 | Brandon | Florida | 33511. | United States |
| Sun Pharma Site 06 | Fort Lauderdale | Florida | 33308 | United States |
| Sun Pharma Site 04 | Miami | Florida | 33175 | United States |
| Sun Pharma Site 05 | Miramar | Florida | 33027 | United States |
| Sun Pharma Site 10 | Ormond Beach | Florida | 32174 | United States |
| Sun Pharma Site 14 | West Lafayette | Indiana | 47906 | United States |
| Sun Pharma Site 12 | Baton Rouge | Louisiana | 70809 | United States |
| Sun Pharma Site 13 | New Orleans | Louisiana | 70115 | United States |
| Sun pharma site 31 | Boston | Massachusetts | 02111 | United States |
| Sun Pharma Site 07 | Troy | Michigan | 48084 | United States |
| Sun Pharma Site 29 | East Greenwich | Rhode Island | 02818 | United States |
| Sun Pharma Site 08 | Warwick | Rhode Island | 02886 | United States |
| Sun Pharma Site 03 | Dallas | Texas | 75234 | United States |
| Sun Pharma Site 16 | Pflugerville | Texas | 78660 | United States |
| Sun Pharma Site 11 | Mill Creek | Washington | 98012 | United States |
| Sun Pharma Site 19 | Ahmedabad | Gujarat | 380016 | India |
| Sun Pharma Site 20 | Gandhinagar | Gujarat | 382428 | India |
| Sun Pharma Site 28 | Rajkot | Gujarat | 360005 | India |
| Sun Pharma Site 23 | Bangalore | Karnataka | 560074 | India |
| Sun PharmaSite 24 | Mysuru | Karnataka | 570001 | India |
| Sun Pharma Site 21 | Aurangabad | Maharashtra | 431001 | India |
| Sun Pharma Site 25 | Nashik | Maharashtra | 422101 | India |
| Sun Pharma Site 26 | Pune | Maharashtra | 411005 | India |
| Sun Pharma Site 17 | Rājsamand | Rajasthan | 313202 | India |
| Sun Pharma Site 27 | Lucknow | Uttar Pradesh | 226003 | India |
| Sun Pharma Site 18 | Lucknow | Uttar Pradesh | 226005 | India |
| Sun Pharma Site 22 | Chandigarh | 160012 | India |
Part I: Up to 24 weeks: No subjects
Part II: week 24 to week 52: Subjects initially randomized to placebo were rerandomized to AS012 dose 2x
Part III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment.
| FG002 | Placebo to AS012 Dose Regimen IV at Week 24 | Part I: Up to 24 weeks: No subjects Part II: week 24 to week 52: Subjects initially randomized to placebo were rerandomized to AS012 dose 6x Part III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment. |
| FG003 | AS012 Dose Regimen I | Part I: Up to 24 weeks: Subjects were randomized to AS012 dose x Part II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52). Part III: week 52 to week 64: After week 52,the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment. |
| FG004 | AS012 Dose Regimen II | Part I: Up to 24 weeks: Subjects were randomized to AS012 dose 2x Part II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52). Part III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment. |
| FG005 | AS012 Dose Regimen III | Part I: Up to 24 weeks: Subjects were randomized to AS012 dose 4x Part II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52). Part III: week 52 to week 64: After week 52, the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment. |
| FG006 | AS012 Dose Regimen IV | Part I: Up to 24 weeks: Subjects were randomized to AS012 dose 6x Part II: week 24 to week 52: Subjects originally randomized to AS012 doses remained on their assigned dosing regimen until the end of Part II (week 52). Part III: week 52 to week 64: After week 52 the study treatment was stopped and all subjects entered the follow-up period to monitor safety and tolerability for 12 weeks after the last dose of study treatment. |
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| NOT COMPLETED |
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| Part 2 |
|
| Part 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Placebo to AS012 Dose Regimen II at Week 24 | Placebo to AS012 dose 2x at Week 24 |
| BG002 | Placebo to AS012 Dose Regimen IV at Week 24 | Placebo to AS012 dose 6x at Week 24 |
| BG003 | AS012 Dose Regimen I | AS012 dose x |
| BG004 | AS012 Dose Regimen II | AS012 dose 2x |
| BG005 | AS012 Dose Regimen III | AS012 dose 4x |
| BG006 | AS012 Dose Regimen IV | AS012 dose 6x |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Subjects initially randomized to placebo were rerandomized to AS012 dose 2x or AS012 dose 6x in Part II of the study and therefore the data are reported separately for the "Placebo to AS012 Dose Regimen" arms. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Subjects initially randomized to placebo were rerandomized to AS012 dose 2x or AS012 dose 6x in Part II of the study and therefore the data are reported separately for the "Placebo to AS012 Dose Regimen" arms. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Subjects initially randomized to placebo were rerandomized to AS012 dose 2x or AS012 dose 6x in Part II of the study and therefore the data are reported separately for the "Placebo to AS012 Dose Regimen" arms. | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Vitiligo Area Scoring Index Score | Vitiligo Area Scoring Index score: numeric score that can range from 0 to 100, with higher VASI scores denoting poorer the disease state | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Mean Change From Baseline in Vitiligo Extent Score (VES) on Clinical Pictures | The Vitiligo Extent Score (VES) measures the overall vitiligo involvement in the body based on clinical pictures reflecting the natural distribution of the disease across 19 body areas (e.g., face, trunk, arms, legs, hands, axillae, back, gluteal). For each area, one representative image is selected, assigning one of six degrees of involvement (1%, 5%, 10%, 25%, 50%, 75%). The total and final score is the sum of the measurements from all areas, calculated using a conversion table available in the online calculator (www.vitiligo-calculator.com), and expressed as the extension of body surface area affected (0-100). Higher scores indicate worse clinical involvement. The VES change from baseline to Week 24 was assessed for the ITT population. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Mean Change in Vitiligo Impact Patient Scale | Subjects will be asked to complete a questionnaire to assess the burden experienced by individuals affected. For each of the statements in the Vitiligo Impact Patient Scale, 7 responses are suggested: always, very often, often, sometimes, rarely, never and not applicable. The individual answered as spontaneously as possible while thinking about their situation over the last 7 days. Summary scores range from 0 to 100. Higher values indicate a worse clinical condition. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | Physician's Global Assessment Scores | Description: The investigator will perform an average assessment of all vitiligo lesions. The following scale will be used for the PGA: Score 0= No involvement, Score 1= Limited, Score 2= moderate, Score 3= Extensive or Score 4= Very extensive. Higher values indicate a worse clinical condition. The static Physician's Global Assessment determines vitiligo extend at a single point in time, without taking the baseline disease condition into consideration, in other words, represents the Proportion of subjects achieving a PGA score of "no involvement" (score 0) or "limited extent" (score 1) with at least 2-point reduction from Baseline Week 52. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Mean Change From Baseline in Dermatology Life Quality Index | The DLQI scores are based on the response from the patient. Each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired OR lower scores indicate better quality of life. | Posted | Mean | Standard Deviation | score on a scale | Week 52 |
|
64 Week
The Safety Population will consist of all subjects who were randomized into the study and dispensed study drug. This population will be the primary population for the safety analysis.
Subjects will be analyzed according to the actual treatment received
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Part I | Placebo - Part I | 0 | 59 | 0 | 59 | 0 | 59 |
| EG001 | AS012 Dose Regimen I- Part I | AS012 dose x- Part I | 0 | 62 | 0 | 62 | 0 | 62 |
| EG002 | AS012 Dose Regimen II - Part I | AS012 dose 2x- Part I | 0 | 70 | 0 | 70 | 0 | 70 |
| EG003 | AS012 Dose Regimen III - Part I | AS012 dose 4x- Part I | 0 | 63 | 0 | 63 | 0 | 63 |
| EG004 | AS012 Dose Regimen IV - Part I | AS012 dose 6x- Part I | 0 | 72 | 0 | 72 | 0 | 72 |
| EG005 | Placebo to AS012 Dose Regimen II at Week 24 - Part II | Placebo to AS012 dose 2x at Week 24 - Part II | 0 | 20 | 0 | 20 | 1 | 20 |
| EG006 | Placebo to AS012 Dose Regimen IV at Week 24 - Part II | Placebo to AS012 dose 6x at Week 24 - Part II | 0 | 20 | 0 | 20 | 0 | 20 |
| EG007 | AS012 Dose - Regimen I - Part II | AS012 dose X- Part II | 0 | 44 | 0 | 44 | 0 | 44 |
| EG008 | AS012 Dose Regimen II - Part II | AS012 dose 2 x - Part II | 0 | 59 | 0 | 59 | 0 | 59 |
| EG009 | AS012 Dose Regimen III - Part II | AS012 dose 4 x - Part II | 0 | 46 | 0 | 46 | 0 | 46 |
| EG010 | AS012 Dose Regimen IV - Part II | AS012 dose 6 x - Part II | 0 | 54 | 0 | 54 | 0 | 54 |
| EG011 | AS012 - Part III | treatment free | 0 | 162 | 0 | 162 | 0 | 162 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fabio Ikedo | Aché Laboratórios Farmacêuticos S.A | 55 11 26086933 | fabio.ikedo@ache.com.br |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | Oct 9, 2024 | SAP_003.pdf |
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| Placebo to AS012 Regimens |
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| Placebo to AS012 Regimens |
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| Placebo to AS012 Regimens |
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| Superiority |
| ANCOVA | 0.2989 | Superiority |
| ANCOVA | 0.3328 | Superiority |
AS012 dose 4x
| OG004 | AS012 Dose Regimen IV | AS012 dose 6x |
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AS012 dose 6x
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AS012 dose 2x
| OG004 | AS012 Dose Regimen III | AS012 dose 4x |
| OG005 | AS012 Dose Regimen IV | AS012 dose 6x |
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|
AS012 dose 4x
| OG005 | AS012 Dose Regimen IV | AS012 dose 6x |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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