A Multicenter, Randomized, Participant- and Investigator -Blinded, Placebo-controlled, Phase 2a Study to Assess the Efficacy, Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
Novartis Pharmaceuticals
Summary
The main purpose of this Ph2a study is to evaluate the preliminary efficacy, safety and tolerability of GIA632 when administered to adult participants with moderate to severe atopic dermatitis (AD).
Description
This is a randomized, placebo-controlled, parallel-group, non-confirmatory, investigator and participant blinded study in adult participants with moderate to severe AD.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Able and willing to sign the informed consent form * Patients with a diagnosis of atopic dermatitis and disease for at least 1 year * Moderate to severe atopic dermatitis Key Exclusion Criteria: * Participants with a clinically significant medical condition or infectious disease (as specified in the protocol) * Participants with any clinically significant abnormal clinical laboratory tests, vital signs, physical examination or ECG * Participant with any other active inflammatory skin disease would interfere with the appropriate assessment of atopic dermatitis in th…
Interventions
- DrugGIA632
Active treatment arm
- OtherPlacebo
Placebo treatment arm
Locations (28)
- Ctr for Dermatology Clinical ResFremont, California
- Aesthetics Skin Care Dermatologic SurgeryRockville, Maryland
- Care Access HobokenHoboken, New Jersey
- Novartis Investigative SitePleven
- Novartis Investigative SiteSofia
- Novartis Investigative SiteSofia