Non-segmental VitiligoPhase 2VITESSNCT07431177
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
A Phase 2 study testing GIA632 in people with Non-segmental Vitiligo, run by Novartis Pharmaceuticals at 83 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- GIA632
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 83 sitesin 12 countries
- Study dates
- 9 Mar 2026to 28 Jan 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study
- Male or female as assigned at birth ≥ 18 years of age at the time of screening
- Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator
- Non-segmental vitiligo, as assessed at screening, as
- ≥ 0.5% Body Surface Area (BSA) on the face and F-VASI score ≥ 0.5
- ≥ 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60
Who cannot join
- Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires
- Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations [such as piebaldism, Waardenburg, etc.], chemical- or druginduced leukoderma, etc.)
- Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors
- Individual who previously attempted or completed depigmentation therapy for NSV
- Use of prohibited medication \& treatments. Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
83 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
83 sites in 12 countries
United States24 sites, 24 recruiting
- Recruiting
Uni Of Michigan Health System
Ann Arbor, Michigan, 48109
Nicole Mahn, +1 734 936 5504, nnechipo@med.umich.edu
Michael T Goldfarb
- Recruiting
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Luis Leal Ruiz, +1 713 661 4383, luis.leal@bellairedermatology.com
Craig F Teller
- Recruiting
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, 35244
Wes Booth, +1 205 778 1564, wbooth@cahabaderm.com
Vlada Groysman
- Recruiting
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Lee Campbell, +1 810 455 1600, lcampbell@hamzavi.com
Iltefat Hamzavi
- Recruiting
First OC Dermatology
Fountain Valley, California, 92708
Keiry Espinoza, +1 714 531 2966, kespinoza@dermcaremgt.com
Vivian Laquer
- Recruiting
Endeavor Health
Glenview, Illinois, 60077
Jalen Corey, +1 847 663 6814, jalen.corey@endeavorhealth.org
Shannon Ewing
- Recruiting
Encore Medical Research
Hollywood, Florida, 33024
Yeniska Hall, +1 954 400 1725, yhall@encoremedicalresearch.com
Jerome Obed
- Recruiting
Center for Clinical Studies
Houston, Texas, 77030
Perla Rivas, +1 713 528 8818, privas@ccstexas.com
Stephen K Tyring
- Recruiting
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256
Michelle Riggs, +1 317 516 5030#102, mgaidzik@ecommunity.com
Kenneth Dawes
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Jarell C Hughes, +1 904 953 2000, hughes.jarell@mayo.edu
Ashley Wentworth
- Recruiting
Las Vegas Dermatology
Las Vegas, Nevada, 89144
Faith Limon, +1 702 456 3120, ftrujillo@lvderm.com
Harry Lawrence Greenberg
- Recruiting
Miami Derm and Laser Institute
Miami, Florida, 33173
Swanee Cepero, +1 305 279 6060, swaneec@miamidermlaser.com
Jill Waibel
- Recruiting
International Clinical Research Tennessee LCC
Murfreesboro, Tennessee, 37130
+1 615 410 3450
Christina Feser
- Recruiting
Virginia Clinical Research
Norfolk, Virginia, 23507
Crystal Temple, +1 757 625 0151, ctemple@vcrinc.org
David M Pariser
- Recruiting
Skin Specialists PC
Omaha, Nebraska, 68144
Schyler Schriever, +1 402 334 7546, Schyler@LovelySkin.com
Joel Schlessinger
- Recruiting
Austin Inst for Clinical Research
Pflugerville, Texas, 78660
Tolga Han, +1 512 279 2545, tolga.han@atxresearch.com
Edward Lain
- Recruiting
ACRC Trials
Plano, Texas, 75024
Jani Taylor, +1 972 354 1520, JaniT@acrctrials.com
Seemal Rohit Desai
- Recruiting
Oregon Medical Research Center
Portland, Oregon, 97223
Megan Lamey, +1 503 245 0315, mlamey@oregonmedicalresearch.com
Benjamin D Ehst
- Recruiting
DermAssociates LLC
Rockville, Maryland, 20850
Meheret Afework, mafework@usdermpartners.com
Benjamin N Lockshin
- Recruiting
MedDerm Associates
San Diego, California, 92103
Kristian Cadag, +1 619 243 7015, kcadag@medderm.net
Michelle Pelle
- Recruiting
Global Clinical Professionals
St. Petersburg, Florida, 33714
Madelaine Perez, +1 727 520 1427, mperez@researchgcp.com
Wanda M Boote
- Recruiting
Equity Medical
The Bronx, New York, 10455
Luana Cabreja, lcabreja@equity-med.com
Michael Cameron
- Recruiting
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Shawn Ahoubim, +1 888 367 1850, clinicaltrials@calderm.net
Navid Ezra
- Recruiting
Revival Research Institute
Troy, Michigan, 48084
Madhuri Para, +1 248 564 1485, mpara@rev-research.com
Ali Moiin
Germany8 sites, 8 recruiting
- Recruiting
Novartis Investigative Site
Bad Bentheim, 48455
- Recruiting
Novartis Investigative Site
Bielefeld, 33647
- Recruiting
Novartis Investigative Site
Hamburg, 20354
- Recruiting
Novartis Investigative Site
Hanover, 30625
- Recruiting
Novartis Investigative Site
Lübeck, 23538
- Recruiting
Novartis Investigative Site
Munich, Bavaria, 81377
- Recruiting
Novartis Investigative Site
Münster, 48149
- Recruiting
Novartis Investigative Site
Tübingen, 72076
Spain8 sites, 8 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08041
- Recruiting
Novartis Investigative Site
Córdoba, 14004
- Recruiting
Novartis Investigative Site
Granada, 18016
- Recruiting
Novartis Investigative Site
Madrid, 28006
- Recruiting
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Pontevedra, 36003
- Recruiting
Novartis Investigative Site
Santiago de Compostela, A Coruna, 15706
- Recruiting
Novartis Investigative Site
Seville, 41009
France7 sites, 7 recruiting
- Recruiting
Novartis Investigative Site
Bordeaux, 33075
- Recruiting
Novartis Investigative Site
Brest, 29609
- Recruiting
Novartis Investigative Site
Créteil, 94010
- Recruiting
Novartis Investigative Site
Nice, 06202
- Recruiting
Novartis Investigative Site
Reims, 51100
- Recruiting
Novartis Investigative Site
Rouen, 76031
- Recruiting
Novartis Investigative Site
Toulouse, 31400
Canada6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Calgary, Alberta, T2J 7E1
- Recruiting
Novartis Investigative Site
Mississauga, Ontario, L4Y 4C5
- Recruiting
Novartis Investigative Site
Newmarket, Ontario, L3Y 5G8
- Recruiting
Novartis Investigative Site
Québec, Quebec, G2G 2R1
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M3H 5Y8
- Recruiting
Novartis Investigative Site
Winnipeg, Manitoba, R3M 3Z4
India6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat, 380016
- Recruiting
Novartis Investigative Site
Bangalore, Karnataka, 560074
- Recruiting
Novartis Investigative Site
Belagavi, Karnataka, 590010
- Recruiting
Novartis Investigative Site
Mysore, Karnataka, 570001
- Recruiting
Novartis Investigative Site
Nashik, Maharashtra, 422101
- Recruiting
Novartis Investigative Site
Patna, Bihar, 801507
Japan6 sites, 6 recruiting
- Recruiting
Novartis Investigative Site
Kofu, Yamanashi, 4008506
- Recruiting
Novartis Investigative Site
Nagoya, Aichi-ken, 4578510
- Recruiting
Novartis Investigative Site
Nagoya, Aichi-ken, 4678602
- Recruiting
Novartis Investigative Site
Niigata, 9518520
- Recruiting
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1600023
- Recruiting
Novartis Investigative Site
Urayasu, Chiba, 2790021
Argentina5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1425DKG
- Recruiting
Novartis Investigative Site
Caba, Buenos Aires, C1119ACN
- Recruiting
Novartis Investigative Site
Caba, C1015ABO
- Recruiting
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS
- Recruiting
Novartis Investigative Site
San Miguel de Tucumán, T4000AXL
China4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100050
- Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, 510091
- Recruiting
Novartis Investigative Site
Shanghai, 200040
- Recruiting
Novartis Investigative Site
Wuhan, Hubei, 430022
Italy4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Ancona, AN, 60020
- Recruiting
Novartis Investigative Site
Cona, FE, 44124
- Recruiting
Novartis Investigative Site
Milan, MI, 20122
- Recruiting
Novartis Investigative Site
Rozzano, MI, 20089
Australia3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Melbourne, Victoria, 3000
- Recruiting
Novartis Investigative Site
Sydney, New South Wales, 2010
- Recruiting
Novartis Investigative Site
Waitara, New South Wales, 2077
Netherlands2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Amsterdam, North Holland, 1105 AZ
- Recruiting
Novartis Investigative Site
Rotterdam, South Holland, 3015 GD
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase IIb Study to Assess the Efficacy and Safety of GIA632 in Adult Participants With Non-segmental Vitiligo Followed by an Extension Period
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.
Read the detailed description
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.
- Conditions
- Non-segmental Vitiligo
- Being tested
- GIA632, Placebo
- Keywords
- Phase 2b, interventional, vitiligo, efficacy, safety, dose ranging
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIA632Drug
GIA632 will be administered during the 48-week core period.
PlaceboDrug
Placebo will be administered during the 48-week core period.
| Study group | Role | What they receive |
|---|---|---|
| GIA632 Arm 1 | Experimental | GIA632 will be administered during the 48-week core period. Receives: Drug: GIA632 |
| GIA632 Arm 2 | Experimental | GIA632 will be administered during the 48-week core period. Receives: Drug: GIA632 |
| GIA632 Arm 3 | Experimental | GIA632 will be administered during the 48-week core period. Receives: Drug: GIA632 |
| GIA632 Arm 4 | Experimental | GIA632 will be administered during the 48-week core period. Receives: Drug: GIA632 |
| Placebo | Placebo comparator | Placebo will be administered during the 48-week core period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (6)
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.
Measured: Baseline, Week 24
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12, Week 24, Week 36, and at Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start9 Mar 2026
- Primary completion6 Jun 2028 (estimated)
- Study completion28 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431177
- Sponsor's protocol ID
- CGIA632B12201
- Other IDs
- 2025-522301-37-00, 2025
- Acronym
- VITESS
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.