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GIA632

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Novartis AG|Last Updated: Jul 8, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical trial landscape

GIA632 · 2 trials · 2 indications

Phase 2 2
NCT07431177A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental VitiligoNon-segmental Vitiligo
RECRUITING210 Analytics
NCT07220577Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic DermatitisAtopic Dermatitis
ACTIVE NOT_RECRUITING34 Analytics
PHASE2RECRUITING
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Non-segmental VitiligoUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
Study Endpoints
Primary Endpoints
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
Baseline, Week 24

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.

IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
Baseline, Week 16

To assess the efficacy of GIA632 compared to placebo at week 16

Secondary Endpoints
Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)
Baseline, Week 24
Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.
Baseline, Week 24
Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)
Baseline, Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GIA632 Arm 1EXPERIMENTALGIA632 will be administered during the 48-week core period.
GIA632 Arm 2EXPERIMENTALGIA632 will be administered during the 48-week core period.
GIA632 Arm 3EXPERIMENTALGIA632 will be administered during the 48-week core period.
GIA632 Arm 4EXPERIMENTALGIA632 will be administered during the 48-week core period.
PlaceboPLACEBO_COMPARATORPlacebo will be administered during the 48-week core period.
GIA632EXPERIMENTALActive treatment arm
Interventions
NameTypeDescription
GIA632DRUGGIA632 will be administered during the 48-week core period.
PlaceboDRUGPlacebo will be administered during the 48-week core period.
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Eligibility Criteria
Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites52

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 ...

Countries:United StatesAustraliaCanadaChinaFranceGermanyIndiaItalyJapanNetherlandsSpainBulgariaCzechiaMalaysiaPolandSingapore
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Recent Changes (Last 90 Days)
LOWJul 8, 2026NCT07431177lastUpdatePostDate: changed
LOWJul 8, 2026NCT07431177lastUpdatePostDate: changed
LOWJun 22, 2026NCT07431177lastUpdatePostDate: changed
LOWJun 22, 2026NCT07431177lastUpdatePostDate: changed
LOWJun 5, 2026NCT07431177lastUpdatePostDate: changed
LOWJun 5, 2026NCT07431177lastUpdatePostDate: changed
LOWJun 5, 2026NCT07431177lastUpdatePostDate: changed
LOWJun 5, 2026NCT07431177lastUpdatePostDate: changed
LOWMay 28, 2026NCT07431177lastUpdatePostDate: changed
LOWMay 28, 2026NCT07431177lastUpdatePostDate: changed
LOWMay 26, 2026NCT07431177primaryCompletionDate: changed
HIGHMay 26, 2026NCT07220577Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07431177studyFirstPostDate: changed
LOWMay 24, 2026NCT07220577studyFirstPostDate: changed