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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06947993

Enrollment

224

Registered

2025-04-27

Start date

2025-05-16

Completion date

2028-12-22

Last updated

2026-08-19

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

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, Dermatitis, Eczema, Moderate to severe

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.

Interventions

DRUGGHZ339

GHZ339 administered at dose A, B, C and D

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
EASI-75 response 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. EASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline.
Investigator Global Assessment (IGA) response at Week 16	Baseline, Week 16	The IGA rating scale will be used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The IGA score ranges from 0 (clear) to 4 (severe). IGA response is defined as clear or almost clear score with at least a 2 point-reduction from baseline

Countries

Argentina, Canada, China, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States

Contacts

CONTACTNovartis Pharmaceuticals

novartis.email@novartis.com1-888-669-6682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026