Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GIA632 · 3 trials · 3 indications
IGA response is defined as an Investigator Global Assessment score of 0 (clear) or 1 (almost clear). The IGA is measured on a 5-point scale ranging from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
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.
To assess the efficacy of GIA632 compared to placebo at week 16
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 1 | EXPERIMENTAL | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 2 | EXPERIMENTAL | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 3 | EXPERIMENTAL | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 - Treatment regimen 4 | EXPERIMENTAL | Participants will receive GIA632 according to the treatment regimen assigned at randomization during the study treatment period. |
| GIA632 Arm 1 | EXPERIMENTAL | GIA632 will be administered during the 48-week core period. |
| GIA632 Arm 2 | EXPERIMENTAL | GIA632 will be administered during the 48-week core period. |
| GIA632 Arm 3 | EXPERIMENTAL | GIA632 will be administered during the 48-week core period. |
| GIA632 Arm 4 | EXPERIMENTAL | GIA632 will be administered during the 48-week core period. |
| GIA632 | EXPERIMENTAL | Active treatment arm |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching placebo |
| GIA632 | DRUG | GIA632 administered according to the assigned study treatment regimen. |
Key Inclusion Criteria: * Male or female (as assigned at birth) participants ≥ 18 years of age at the time of screening. * Individuals with a diagnosis of cLP, confirmed * histologically by a skin biopsy (either historically within 1 year prior to screening or at screening if historical one not ava...
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GIA632 is an investigational small molecule drug developed by Novartis AG for dermatology indications. It is being studied in Phase 2 clinical trials for moderate to severe cutaneous lichen planus, non-segmental vitiligo, and moderate to severe atopic dermatitis. GIA632 has not been approved by the FDA and remains in clinical development.
GIA632 is being evaluated for three inflammatory skin conditions: moderate to severe cutaneous lichen planus, non-segmental vitiligo, and moderate to severe atopic dermatitis. All three programs are in Phase 2. GIA632 is investigational and has not received FDA approval for any indication.
GIA632 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is running the Phase 2 clinical program for GIA632 across dermatology indications including cutaneous lichen planus, non-segmental vitiligo, and atopic dermatitis.
GIA632 is in Phase 2 clinical development. Novartis is running a Phase 2b dose-ranging study in non-segmental vitiligo, a Phase 2 study in moderate to severe cutaneous lichen planus, and a Phase 2a study in moderate to severe atopic dermatitis. GIA632 is investigational and has not been approved by the FDA.
GIA632 is being studied in three Phase 2 trials. NCT07775924 is a recruiting Phase 2 study in moderate to severe cutaneous lichen planus with 259 participants. NCT07431177 is a recruiting Phase 2b dose-ranging study in non-segmental vitiligo with 210 participants. NCT07220577 is a Phase 2a study in moderate to severe atopic dermatitis with 34 participants.
No. GIA632 is an investigational small molecule that remains in Phase 2 clinical development and has not been approved by the FDA. Novartis is currently running three Phase 2 trials of GIA632 in cutaneous lichen planus, non-segmental vitiligo, and atopic dermatitis.