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Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis

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 - CADPT17A12201

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250233
Enrollment
18
Registered
2025-07-15
Start date
2025-07-18
Completion date
Unknown
Last updated
2025-08-15

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

Conditions

Atopic Dermatitis

Interventions

Drug: GHZ339 (administered at dose A, B, C and D) Placebo: Matching placebo

Sponsors

Maruyama Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Able and willing to sign the informed consent - Patients with a diagnosis of AD and onset of disease for at least 1 year - Moderate to severe AD

Exclusion criteria

Exclusion criteria: - Participants with a clinically significant medical condition or infectious disease - Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG - Participant with any other active inflammatory skin disease - Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension) - Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)

Design outcomes

Primary

MeasureTime frame
Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 [Time Frame: Baseline, Week 16]

Countries

Japan, United States

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026