Clinical trial NCT06947993: Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Dermatitis
Eczema
Moderate to severe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: EASI-75 response at Week 16
timeFrame: Baseline, Week 16
measure: Investigator Global Assessment (IGA) response at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Macon
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Brighton
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Joseph
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Cypress
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
References: