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

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Novartis

Status and phase

Enrolling
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Placebo
Drug: GHZ339

Study type

Interventional

Funder types

Industry

Identifiers

NCT06947993
2024-519081-49 (EudraCT Number)
CADPT17A12201

Details and patient eligibility

About

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

Full 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.

Enrollment

224 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

224 participants in 5 patient groups, including a placebo group

GHZ339 Dose A
Experimental group
Description:
Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Treatment:
Drug: GHZ339
GHZ339 Dose B
Experimental group
Description:
Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2
Treatment:
Drug: GHZ339
GHZ339 Dose C
Experimental group
Description:
Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2
Treatment:
Drug: GHZ339
GHZ339 Dose D
Experimental group
Description:
Participants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2
Treatment:
Drug: GHZ339
Placebo
Placebo Comparator group
Description:
Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
Treatment:
Drug: GHZ339
Drug: Placebo

Trial contacts and locations

11

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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