Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GHZ339, Placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Canada, China, Czechia +12
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD.
The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.
Interventions
- Drug GHZ339
GHZ339 administered at dose A, B, C and D - Drug Placebo
Matching placebo
Primary outcome measures
- Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 [Time frame: Baseline, Week 16]
Secondary outcome measures (2)
- EASI-75 response at Week 16 [Time frame: Baseline, Week 16]
- Investigator Global Assessment (IGA) response at Week 16 [Time frame: Baseline, Week 16]
Eligibility criteria
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 medical condition or infectious disease (specified in sub-protocol)
- 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)
Additional inclusion and exclusion criteria may apply depending on the intervention specific requirements
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 22 centers
- Novartis Investigative Site — Birmingham
- Novartis Investigative Site — Birmingham
- Novartis Investigative Site — Fort Smith
- Novartis Investigative Site — Fountain Valley
- Novartis Investigative Site — Los Angeles
- Novartis Investigative Site — Sacramento
- Novartis Investigative Site — Santa Ana
- Novartis Investigative Site — Santa Monica
- … and 14 more centers
Germany · 9 centers
- Novartis Investigative Site — Frankfurt am Main
- Novartis Investigative Site — Mainz
- Novartis Investigative Site — Bad Bentheim
- Novartis Investigative Site — Dresden
- Novartis Investigative Site — Hamburg
- Novartis Investigative Site — Heidelberg
- Novartis Investigative Site — Magdeburg
- Novartis Investigative Site — Münster
- … and 1 more center
China · 8 centers
- Novartis Investigative Site — Guangzhou
- Novartis Investigative Site — Shantou
- Novartis Investigative Site — Changsha
- Novartis Investigative Site — Changchun
- Novartis Investigative Site — Hangzhou
- Novartis Investigative Site — Beijing
- Novartis Investigative Site — Beijing
- Novartis Investigative Site — Shanghai
Japan · 8 centers
- Novartis Investigative Site — Nagoya
- Novartis Investigative Site — Matsudo
- Novartis Investigative Site — Kawasaki
- Novartis Investigative Site — Yokohama
- Novartis Investigative Site — Habikino
- Novartis Investigative Site — Shinagawa Ku
- Novartis Investigative Site — Fukuoka
- Novartis Investigative Site — Kyoto
France · 7 centers
- Novartis Investigative Site — Brest
- Novartis Investigative Site — Lille
- Novartis Investigative Site — Lorient
- Novartis Investigative Site — Paris
- Novartis Investigative Site — Pierre-Bénite
- Novartis Investigative Site — Reims
- Novartis Investigative Site — Rouen
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Canada · 5 centers
- Novartis Investigative Site — Edmonton
- Novartis Investigative Site — Hamilton
- Novartis Investigative Site — Markham
- Novartis Investigative Site — Montreal
- Novartis Investigative Site — Verdun
Hungary · 5 centers
- Novartis Investigative Site — Pécs
- Novartis Investigative Site — Debrecen
- Novartis Investigative Site — Budapest
- Novartis Investigative Site — Budapest
- Novartis Investigative Site — Szeged
Poland · 5 centers
- Novartis Investigative Site — Warsaw
- Novartis Investigative Site — Katowice
- Novartis Investigative Site — Lodz
- Novartis Investigative Site — Lublin
- Novartis Investigative Site — Warsaw
Slovakia · 5 centers
Center list to be confirmed — check the primary protocol.
Czechia · 4 centers
- Novartis Investigative Site — Plzen Bory
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Prague
- Novartis Investigative Site — Prague
Argentina · 3 centers
- Novartis Investigative Site — Caba
- Novartis Investigative Site — Caba
- Novartis Investigative Site — Rosario
Taiwan · 3 centers
Center list to be confirmed — check the primary protocol.
Italy · 2 centers
- Novartis Investigative Site — Ancona
- Novartis Investigative Site — Cona
Netherlands · 2 centers
- Novartis Investigative Site — Rotterdam
- Novartis Investigative Site — Utrecht
South Korea · 2 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06947993 · CADPT17A12201 · 2024-519081-49