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...
Top 20 of 25 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 9 | PHASE3 | Upadacitinib, corticosteroids |
| Pfizer Inc. | PFE | 11 | PHASE3 | Abrocitinib |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Lebrikizumab, Corticosteroid |
| Sanofi SA Sponsored ADR | SNY | 13 | PHASE3 | Amlitelimab |
| Regeneron Pharmaceuticals, Inc. | REGN | 4 | PHASE3 | Dupilumab |
| Incyte Corporation | INCY | 3 | PHASE3 | Ruxolitinib, Vehicle |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof, 1%, Vehicle |
| Apogee Therapeutics, Inc. | APGE | 3 | PHASE2 | APG777 |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | GIA632 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE2 | Soquelitinib |
| Nektar Therapeutics | NKTR | 1 | PHASE2 | Rezpegaldesleukin |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE2 | Barzolvolimab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| Aclaris Therapeutics, Inc. | ACRS | 1 | PHASE2 | ATI-045 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-914 |
| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | 611 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE1 | ARQ-234 |
GIA632 is an investigational small molecule being developed by Novartis for dermatological conditions. It is being studied in Phase 2 clinical trials for moderate to severe atopic dermatitis, non-segmental vitiligo, and moderate to severe cutaneous lichen planus. The drug is administered to adult participants aged 18 years and older.
GIA632 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for multiple dermatological indications, including atopic dermatitis, non-segmental vitiligo, and cutaneous lichen planus.
GIA632 is currently in Phase 2 clinical development. It is being evaluated in three separate Phase 2 trials: a Phase 2a study for atopic dermatitis, a Phase IIb dose-ranging study for non-segmental vitiligo, and a Phase 2 study for cutaneous lichen planus. The drug is investigational and has not been approved by regulatory authorities.
GIA632 is being studied in three active Phase 2 trials. NCT07220577 is a Phase 2a study in moderate to severe atopic dermatitis with 34 participants. NCT07431177 is a Phase IIb dose-ranging study in non-segmental vitiligo with 210 participants. NCT07775924 is a study in moderate to severe cutaneous lichen planus with 259 participants.
Yes, GIA632 is being tested in atopic dermatitis. The Phase 2a trial NCT07220577 is assessing the efficacy, safety, and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis. This trial is active but not recruiting participants and is being conducted in multiple countries including the United States, Bulgaria, Canada, and others.
Yes, GIA632 is being tested in non-segmental vitiligo. The Phase IIb dose-ranging study NCT07431177 is currently recruiting participants to assess the efficacy and safety of GIA632 in individuals with non-segmental vitiligo. This trial is being conducted in numerous countries, including the United States, Argentina, Australia, Canada, China, and Japan.