BridgeMD
Tests treatment safety and results for Non-segmental Vitiligo
Official title A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
ClinicalTrials.gov ID: NCT07431177
What this study is testing
What is GIA632?
GIA632 is an investigational medicine, being studied as a potential treatment for non-segmental vitiligo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.