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A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Non-segmental Vitiligo

Interventions: GIA632, Placebo

Countries: United States, Argentina, Australia, Canada, China, France, Germany, India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (72)

Birmingham, Alabama, United States
Fountain Valley, California, United States
San Diego, California, United States
Thousand Oaks, California, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
St. Petersburg, Florida, United States
Indianapolis, Indiana, United States
Fort Gratiot, Michigan, United States
Troy, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
The Bronx, New York, United States
Portland, Oregon, United States
Murfreesboro, Tennessee, United States
Bellaire, Texas, United States
Houston, Texas, United States
Pflugerville, Texas, United States
Plano, Texas, United States
Norfolk, Virginia, United States
Caba, Buenos Aires, Argentina
Sydney, New South Wales, Australia
Waitara, New South Wales, Australia
Melbourne, Victoria, Australia
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
+ 42 more on CT.gov