Study Description
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.
Interventions
GIA632
Placebo
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1119acn,Argentina
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
Winnipeg,Manitoba,R3m 3z4,Canada
Novartis Investigative Site
Recruiting
Newmarket,Ontario,L3y 5g8,Canada
Novartis Investigative Site
Recruiting
Calgary,Alberta,T2j 7e1,Canada
Novartis Investigative Site
Recruiting
Toronto,Ontario,M3h 5y8,Canada
Novartis Investigative Site
Recruiting
Québec,Quebec,G1v 4x7,Canada
Novartis Investigative Site
Recruiting
Mississauga,Ontario,L4y 4c5,Canada
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510091,China
Novartis Investigative Site
Recruiting
Shanghai,200040,China
Novartis Investigative Site
Recruiting
Beijing,100050,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430022,China
Novartis Investigative Site
Recruiting
Brest,29609,France
Novartis Investigative Site
Recruiting
Rouen,76031,France
Novartis Investigative Site
Recruiting
Reims,51100,France
Novartis Investigative Site
Recruiting
Nice,06202,France
Novartis Investigative Site
Recruiting
Créteil,94010,France
Novartis Investigative Site
Recruiting
Bordeaux,33075,France
Novartis Investigative Site
Recruiting
Toulouse,31400,France
Novartis Investigative Site
Recruiting
Hanover,30625,Germany
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
Lübeck,23538,Germany
Novartis Investigative Site
Recruiting
Bielefeld,33647,Germany
Novartis Investigative Site
Recruiting
Tübingen,72076,Germany
Novartis Investigative Site
Recruiting
Ahmedabad,Gujarat,380016,India
Novartis Investigative Site
Recruiting
Nashik,Maharashtra,422101,India
Novartis Investigative Site
Recruiting
Belagavi,Karnataka,590010,India
Novartis Investigative Site
Recruiting
Mysore,Karnataka,570001,India
Novartis Investigative Site
Recruiting
Bangalore,Karnataka,560074,India
Novartis Investigative Site
Recruiting
Ancona,AN,60020,Italy
Novartis Investigative Site
Recruiting
Rozzano,MI,20089,Italy
Novartis Investigative Site
Recruiting
Milan,MI,20122,Italy
Novartis Investigative Site
Recruiting
Cona,FE,44124,Italy
Novartis Investigative Site
Recruiting
Urayasu,Chiba,279-0021,Japan
Novartis Investigative Site
Recruiting
Nagoya,Aichi-ken,4678602,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
Novartis Investigative Site
Recruiting
Seville,41009,Spain
Novartis Investigative Site
Recruiting
Santiago de Compostela,A Coruna,15706,Spain
Novartis Investigative Site
Recruiting
Córdoba,14004,Spain
Novartis Investigative Site
Recruiting
Madrid,28006,Spain
Novartis Investigative Site
Recruiting
Madrid,28041,Spain
Novartis Investigative Site
Recruiting
Pontevedra,36003,Spain
Clinical Trials Research Institute
Recruiting
Thousand Oaks,California,91320,United States
Navid Ezra
Equity Medical
Recruiting
The Bronx,New York,10455,United States
Michael Cameron
Luana Cabreja
Las Vegas Dermatology
Recruiting
Las Vegas,Nevada,89144,United States
Harry Lawrence Greenberg
Skin Specialists PC
Recruiting
Omaha,Nebraska,68144,United States
Joel Schlessinger
Hamzavi Dermatology
Recruiting
Fort Gratiot,Michigan,48059,United States
Iltefat Hamzavi
Dawes Fretzin Clinical Rea Group
Recruiting
Indianapolis,Indiana,46256,United States
Kenneth Dawes
Center for Clinical Studies
Recruiting
Houston,Texas,77030,United States
Stephen K Tyring
Austin Inst for Clinical Research
Recruiting
Pflugerville,Texas,78660,United States
Edward Lain
Miami Derm and Laser Institute
Recruiting
Miami,Florida,33173,United States
Jill Waibel
Cahaba Derm and skin hlth ctr 27
Recruiting
Birmingham,Alabama,35244,United States
Vlada Groysman
Revival Research Institute
Recruiting
Troy,Michigan,48084,United States
Ali Moiin
MedDerm Associates
Recruiting
San Diego,California,92103,United States
Michelle Pelle
Mayo Clinic Jacksonville
Recruiting
Jacksonville,Florida,32224,United States
Ashley Wentworth
Bellaire Dermatology Associates
Recruiting
Bellaire,Texas,77401,United States
Craig F Teller
First OC Dermatology
Recruiting
Fountain Valley,California,92708,United States
Vivian Laquer
Oregon Medical Research Center
Recruiting
Portland,Oregon,97223,United States
Benjamin D Ehst
Encore Medical Research
Recruiting
Hollywood,Florida,33024,United States
Jerome Obed
ACRC Trials
Recruiting
Plano,Texas,75024,United States
Seemal Rohit Desai
International Clinical Research Tennessee LCC
Recruiting
Murfreesboro,Tennessee,37130,United States
Christina Feser
Virginia Clinical Research
Recruiting
Norfolk,Virginia,23507,United States
David M Pariser
Global Clinical Professionals
Recruiting
St. Petersburg,Florida,33714,United States
Wanda M Boote
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.