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

ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • GHZ339

    Drug

    GHZ339 administered at dose A, B, C and D

  • Placebo

    Drug

    Matching placebo

Treatment groups

224 Participants
are divided into 5 treatment groups
Group A: GHZ339 Dose AExperimental treatment 1 intervention
Group B: GHZ339 Dose BExperimental treatment 1 intervention
Group C: GHZ339 Dose CExperimental treatment 1 intervention
Group D: GHZ339 Dose DExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in the Eczema Area and Severity Index (EASI) score at 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.

Time frame
Baseline, Week 16

Secondary outcomes

1

EASI-75 response at 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.

Time frame
Baseline, Week 16
2

Investigator Global Assessment (IGA) response at 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

Time frame
Baseline, Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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