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A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519081-49-00
Acronym
CADPT17A12201
Enrollment
104
Registered
2025-09-22
Start date
2025-10-28
Completion date
Unknown
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe atopic dermatitis

Brief summary

Percentage change from baseline in the EASI score at Week 16

Detailed description

IGA response at Week 16: IGA score of 0 (clear) or 1 (almost clear) and at least 2 points reduction from baseline IGA response at Week 16, EASI-75 response at Week 16: ≥75% reduction (improvement) from baseline in EASI score response at Week 16, Treatment emergent adverse events, vital signs, ECG, and laboratory assessments

Interventions

DRUGPlacebo to GHZ339
DRUG-
DRUGGHZ339
DRUGTACROLIMUS
DRUGPIMECROLIMUS

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage change from baseline in the EASI score at Week 16

Secondary

MeasureTime frame
IGA response at Week 16: IGA score of 0 (clear) or 1 (almost clear) and at least 2 points reduction from baseline IGA response at Week 16, EASI-75 response at Week 16: ≥75% reduction (improvement) from baseline in EASI score response at Week 16, Treatment emergent adverse events, vital signs, ECG, and laboratory assessments

Countries

Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026