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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522301-37-00 | Other Identifier | EU CTIS |
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The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.
This trial in adult participants ≥ 18 years with non-segmental vitiligo (NSV) consists of a randomized, double-blind, placebo-controlled period to establish and characterize the dose-response relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIA632 Arm 1 | Experimental | GIA632 will be administered during the 48-week core period. |
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| GIA632 Arm 2 | Experimental | GIA632 will be administered during the 48-week core period. |
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| GIA632 Arm 3 | Experimental | GIA632 will be administered during the 48-week core period. |
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| GIA632 Arm 4 | Experimental | GIA632 will be administered during the 48-week core period. |
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| Placebo | Placebo Comparator | Placebo will be administered during the 48-week core period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIA632 | Drug | GIA632 will be administered during the 48-week core period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score. | The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75) | The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. | Baseline, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Derm and skin hlth ctr 27 | Recruiting | Birmingham | Alabama | 35244 | United States |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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| Placebo | Drug | Placebo will be administered during the 48-week core period. |
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| Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score. |
T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. |
| Baseline, Week 24 |
| Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50) | T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. | Baseline, Week 24 |
| Achievement of F-VASI50, F-VASI75, and FVASI90 | The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. F-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the facial vitiligo area scoring index (F-VASI), respectively. | Baseline, Week 12, Week 24, Week 36, and Week 48 |
| Achievement of T-VASI50, T-VASI75, and TVASI90 | T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. T-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the total vitiligo area scoring index (T-VASI), respectively. | Baseline, Week 12, Week 24, Week 36, and Week 48. |
| Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5 | The VNS is a patient-reported outcome (PRO) measure of treatment response, which has been shown to have face validity. This involved an online survey, to identify which aspects of treatment response are most important to participants. A scale with five response options (both words and numbers) is the best available scale to use when assessing treatment response (whereas giving a binary 'yes'/'no' response was more difficult); and a score of 4 or 5 on the scale represents a successful treatment response. | Week 12, Week 24, Week 36, and at Week 48. |
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| Clinical Trials Research Institute | Recruiting | Thousand Oaks | California | 91320 | United States |
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| Global Clinical Professionals | Recruiting | St. Petersburg | Florida | 33714 | United States |
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| Dawes Fretzin Clinical Rea Group | Recruiting | Indianapolis | Indiana | 46256 | United States |
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| Hamzavi Dermatology | Recruiting | Fort Gratiot | Michigan | 48059 | United States |
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| Revival Research Institute | Recruiting | Troy | Michigan | 48084 | United States |
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| Skin Specialists PC | Recruiting | Omaha | Nebraska | 68144 | United States |
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| Las Vegas Dermatology | Recruiting | Las Vegas | Nevada | 89144 | United States |
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| Equity Medical | Recruiting | The Bronx | New York | 10455 | United States |
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| Oregon Medical Research Center | Recruiting | Portland | Oregon | 97223 | United States |
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| International Clinical Research Tennessee LCC | Recruiting | Murfreesboro | Tennessee | 37130 | United States |
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| Bellaire Dermatology Associates | Recruiting | Bellaire | Texas | 77401 | United States |
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| Center for Clinical Studies | Recruiting | Houston | Texas | 77030 | United States |
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| Austin Inst for Clinical Research | Recruiting | Pflugerville | Texas | 78660 | United States |
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| ACRC Trials | Recruiting | Plano | Texas | 75024 | United States |
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| Virginia Clinical Research | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Novartis Investigative Site | Recruiting | Sydney | New South Wales | 2010 | Australia |
| Novartis Investigative Site | Recruiting | Waitara | New South Wales | 2077 | Australia |
| Novartis Investigative Site | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Novartis Investigative Site | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Novartis Investigative Site | Recruiting | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Novartis Investigative Site | Recruiting | Mississauga | Ontario | L4Y 4C5 | Canada |
| Novartis Investigative Site | Recruiting | Newmarket | Ontario | L3Y 5G8 | Canada |
| Novartis Investigative Site | Recruiting | Toronto | Ontario | M3H 5Y8 | Canada |
| Novartis Investigative Site | Recruiting | Québec | Quebec | G1V 4X7 | Canada |
| Novartis Investigative Site | Recruiting | Beijing | 100050 | China |
| Novartis Investigative Site | Recruiting | Shanghai | 200040 | China |
| Novartis Investigative Site | Recruiting | Brest | 29609 | France |
| Novartis Investigative Site | Recruiting | Rouen | 76031 | France |
| Novartis Investigative Site | Recruiting | Toulouse | 31400 | France |
| Novartis Investigative Site | Recruiting | Munich | Bavaria | 81377 | Germany |
| Novartis Investigative Site | Recruiting | Bad Bentheim | 48455 | Germany |
| Novartis Investigative Site | Recruiting | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Recruiting | Münster | 48149 | Germany |
| Novartis Investigative Site | Recruiting | Ahmedabad | Gujarat | 380016 | India |
| Novartis Investigative Site | Recruiting | Bangalore | Karnataka | 560074 | India |
| Novartis Investigative Site | Recruiting | Belagavi | Karnataka | 590010 | India |
| Novartis Investigative Site | Recruiting | Mysore | Karnataka | 570001 | India |
| Novartis Investigative Site | Recruiting | Nashik | Maharashtra | 422101 | India |
| Novartis Investigative Site | Recruiting | Ancona | AN | 60020 | Italy |
| Novartis Investigative Site | Recruiting | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Recruiting | Urayasu | Chiba | 279-0021 | Japan |
| Novartis Investigative Site | Recruiting | Kofu | Yamanashi | 400-8506 | Japan |
| Novartis Investigative Site | Recruiting | Niigata | 9518520 | Japan |
| Novartis Investigative Site | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Novartis Investigative Site | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
| Novartis Investigative Site | Recruiting | Barcelona | 08041 | Spain |
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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