Testing GHZ339 against a placebo for atopic dermatitis
Official title: 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
- Phase 2
- 5 groups
- Sites in Edmonton, Hamilton and 3 more cities
- Recruiting
Interventions
- Medication
GHZ339
GHZ339 administered at dose A, B, C and D
- Medication
Placebo
Matching placebo
Canadian Sites (5)
3 of 5 recruiting
- Recruiting
Novartis Investigative Site
Hamilton, Ontario
- Recruiting
Novartis Investigative Site
Markham, Ontario
- Recruiting
Novartis Investigative Site
Montreal, Quebec
- Not currently recruiting
Novartis Investigative Site
Edmonton, Alberta
- Not currently recruiting
Novartis Investigative Site
Verdun, Quebec
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +of the master protocolProtocolThe detailed plan a study must follow.Read more →:
- +Able and willing to sign the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (IC)
- +Patients with a diagnosis of AD and onset of disease for at least 1 year
- +Moderate to severe AD
- +Key Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteria may apply depending on the intervention specific requirements
Exclusion
- −of the master protocolProtocolThe detailed plan a study must follow.Read more →:
- −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 inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply depending on the intervention specific requirements
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 5 groups in this study.
Groups A, B, C and D receive GHZ339.
Registry label: A: GHZ339 Dose A · B: GHZ339 Dose B · C: GHZ339 Dose C · D: GHZ339 Dose D
Group E, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo, together with one or more of: GHZ339.
Registry label: E: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 100 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 224 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 16.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in the Eczema Area and Severity Index (EASI) score at Week 16 — measured over Baseline, Week 16.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06947993 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About GHZ339Drug
GHZ339 administered at dose A, B, C and D
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Matching placebo
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 100 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 100 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, Week 16.
The study as a whole is currently expected to finish around 2028-12-22.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 224 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Markham, Ontario, Canada; Montreal, Quebec, Canada; Verdun, Quebec, Canada; Troy, Michigan, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).
Other Sites (2)
Novartis Investigative Site
Troy, Michigan, United States
Novartis Investigative Site
Brooklyn, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.