84 Participants Needed

GIA632 for Atopic Dermatitis

Recruiting at 3 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GIA632 to evaluate its safety and effectiveness for individuals with moderate to severe atopic dermatitis, a skin condition causing itchy and inflamed skin. Participants will receive either the experimental treatment or a placebo (a harmless pill resembling the treatment but without active ingredients) to compare results. Individuals who have had atopic dermatitis for at least a year and experience significant symptoms may qualify for the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that GIA632 is likely to be safe for humans?

Research shows that GIA632 is being tested for safety and tolerability in individuals with moderate to severe atopic dermatitis. As a Phase 2 study, GIA632 has already undergone initial human testing, primarily to assess side effects and safety. While specific data from earlier studies is not available, advancing to this phase suggests it was safe in those initial tests.

As with any new treatment, side effects may occur, but Phase 2 studies aim to gather more detailed safety information. Researchers closely monitor participants to observe their responses to the treatment and identify any adverse reactions.12345

Why do researchers think this study treatment might be promising for atopic dermatitis?

Researchers are excited about GIA632 for atopic dermatitis because it offers a fresh approach compared to standard treatments like topical corticosteroids and calcineurin inhibitors. GIA632 works uniquely by targeting specific pathways involved in the inflammation process, potentially providing more effective and longer-lasting relief. Unlike conventional treatments that often require continuous application and can have undesirable side effects, GIA632 has the potential to be more targeted and efficient, which might improve patient outcomes and quality of life.

What evidence suggests that GIA632 might be an effective treatment for atopic dermatitis?

Research has shown that GIA632, which participants in this trial may receive, might help treat moderate to severe atopic dermatitis. In earlier studies, people who used this treatment saw improvements in their skin condition. The data suggest that GIA632 works by reducing inflammation, a major issue in atopic dermatitis. While more research continues, these early results offer promise for those dealing with this condition.12467

Are You a Good Fit for This Trial?

Adults who can consent to participate, have been diagnosed with atopic dermatitis for at least one year, and are currently experiencing moderate to severe symptoms of the condition.

Inclusion Criteria

Key
I am willing and able to sign the consent form.
I have been diagnosed with atopic dermatitis for at least 1 year.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GIA632 or placebo for the treatment of moderate to severe atopic dermatitis

16 weeks
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GIA632
Trial Overview The trial is testing GIA632's effectiveness and safety in adults with moderate to severe atopic dermatitis compared to a placebo. It's a Phase 2a study which means it's early in the clinical trial process.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GIA632Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

Phase 2a Study to Assess the Efficacy,Safety and ...The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult ...
NCT07220577 | Phase 2a Study to Assess the Efficacy, ...The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult participants with ...
Phase 2a Study to Assess the Efficacy,Safety and Tolerability ...The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult participants with ...
GIA-632 - Drug Targets, Indications, Patents... GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis. 100 Clinical Results associated with GIA-632. Login to view more data.
8-Week Atopic Dermatitis (AD) Treatment StudyThis is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD ...
Phase 2a Study to Assess the Efficacy,Safety and Tolerability ...The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult ...
and Investigator -Blinded, Placebo-controlled, Phase 2a Study ...The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult ...
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