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Clinical trials
NCT07431177

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

ClinicalTrials.gov identifier NCT07431177

Novartis reference CGIA632B12201

Show study information as

Condition Non-segmental Vitiligo

Study status Recruiting

Phase 2

Number of participants 210

Gender All

Age 18 to 99 years

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Study details

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

DRUG: GIA632|DRUG: Placebo

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

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

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

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Clinical trials
NCT07431177

Study of an Investigational Treatment for Non-segmental Vitiligo in Adults

ClinicalTrials.gov identifier NCT07431177

Novartis reference CGIA632B12201

Show study information as

Condition Non-segmental Vitiligo

Study status Recruiting

Phase 2

Number of participants 210

Gender All

Age 18 to 99 years

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment in adults with non-segmental vitiligo (a type of vitiligo that often affects both sides of the body). The study also aims to find the best dose to use in future studies.

Participants will receive either the investigational treatment or a placebo. A placebo looks like the investigational treatment but does not contain active medication. The study includes an initial treatment period comparing the investigational treatment with placebo, followed by a longer period to continue checking safety and how vitiligo changes over time.

This study may be an option for
Adults with non-segmental vitiligo may be able to participate if they:

Are 18 years or older
Have non-segmental vitiligo confirmed by a physical skin exam
Have vitiligo on the face and on other (non-face) areas of the body at screening

Interventions

DRUG: GIA632|DRUG: Placebo

Official title

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Sign an informed consent form before joining the study
Be male or female as assigned at birth and be 18 years or older at screening
Have non-segmental vitiligo, with the diagnosis confirmed by a physical exam by the study doctor
Have non-segmental vitiligo at screening with at least 0.5% of the face affected and a face vitiligo score (F-VASI) of at least 0.5
Have at least 3% of non-face body areas affected (at least 3% must be counted in areas other than the hands and feet) and a total body vitiligo score (T-VASI) from 3 to 60

You might not be able to join if

Be unable or unwilling to follow the study procedures or complete study questionnaires
Have segmental vitiligo or mixed vitiligo, or have other skin conditions that could affect study assessments (for example, hypopigmented mycosis fungoides; genetic conditions that affect skin pigment such as piebaldism or Waardenburg; or leukoderma caused by chemicals or drugs)
Have previously used biologic drugs that directly target IL-15 or IL-15 receptors
Have previously tried or completed depigmentation therapy for non-segmental vitiligo
Use medications or treatments that are not allowed in the study
Meet other protocol-defined inclusion or exclusion criteria

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