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GHZ339

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Novartis AG|Last Updated: Dec 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment224
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06947993Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic DermatitisPHASE2 RECRUITING 224May 16, 2025Dec 22, 2028Dec 22, 202599 United States, Argentina +15
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Study Endpoints
Primary Endpoints
Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
Baseline, Week 16

EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.

Secondary Endpoints
EASI-75 response at Week 16
Baseline, Week 16
Investigator Global Assessment (IGA) response at Week 16
Baseline, Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GHZ339 Dose AEXPERIMENTALParticipants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
GHZ339 Dose BEXPERIMENTALParticipants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2
GHZ339 Dose CEXPERIMENTALParticipants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2
GHZ339 Dose DEXPERIMENTALParticipants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2
PlaceboPLACEBO_COMPARATORParticipants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Interventions
NameTypeDescription
GHZ339DRUGGHZ339 administered at dose A, B, C and D
PlaceboDRUGMatching placebo
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites99

Key Inclusion Criteria of the master protocol: * Able and willing to sign the informed consent (IC) * Patients with a diagnosis of AD and onset of disease for at least 1 year * Moderate to severe AD Key Exclusion Criteria of the master protocol: * Participants with a clinically significant medica...

Countries:United StatesArgentinaCanadaChinaCzechiaFranceGermanyHungaryItalyJapanNetherlandsPolandSlovakiaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06947993primaryCompletionDate: changed
LOWMay 24, 2026NCT06947993studyFirstPostDate: changed