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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GHZ339 Dose A 		Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
  • Drug: GHZ339
    GHZ339 administered at dose A, B, C and D
Experimental
GHZ339 Dose B 		Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2
  • Drug: GHZ339
    GHZ339 administered at dose A, B, C and D
Experimental
GHZ339 Dose C 		Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2
  • Drug: GHZ339
    GHZ339 administered at dose A, B, C and D
Experimental
GHZ339 Dose D 		Participants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2
  • Drug: GHZ339
    GHZ339 administered at dose A, B, C and D
Placebo Comparator
Placebo 		Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
  • Drug: GHZ339
    GHZ339 administered at dose A, B, C and D
  • Drug: Placebo
    Matching placebo

Recruiting Locations

UAB Dermatology
Birmingham 4049979, Alabama 4829764 35233
Contact:
Sarah Crawford
sdcrawford@uabmc.edu

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.