Clinical Trials in Poland / NCT07220577
Active, not recruiting
Phase 2
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT07220577 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Atopic Dermatitis
Investigational drug(s) / intervention(s)
GIA632 →Placebo
GIA632: Active treatment arm
Placebo: Placebo treatment arm
Study 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).
Eligibility
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 the opinion of the investigator
* 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)
* Women of childbearing potential unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline — Baseline, Week 16
To assess the efficacy of GIA632 compared to placebo at week 16
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Ctr for Dermatology Clinical Res | Fremont | California | |
| Aesthetics Skin Care Dermatologic Surgery | Rockville | Maryland | |
| Care Access Hoboken | Hoboken | New Jersey | |
| Novartis Investigative Site | Pleven | Bulgaria | |
| Novartis Investigative Site | Sofia | Bulgaria | |
| Novartis Investigative Site | Sofia | Bulgaria | |
| Novartis Investigative Site | Toronto | Ontario | |
| Novartis Investigative Site | Québec | Quebec | |
| Novartis Investigative Site | Ostrava | Poruba | |
| Novartis Investigative Site | Brno | Czechia | |
| Novartis Investigative Site | Prague | Czechia | |
| Novartis Investigative Site | Antony | France | |
| Novartis Investigative Site | Dijon | France | |
| Novartis Investigative Site | Martigues | France | |
| Novartis Investigative Site | Nice | France | |
| Novartis Investigative Site | Berlin | Germany | |
| Novartis Investigative Site | Hamburg | Germany | |
| Novartis Investigative Site | Mainz | Germany | |
| Novartis Investigative Site | Ipoh | Perak | |
| Novartis Investigative Site | George Town | Pulau Pinang | |
| Novartis Investigative Site | Kota Kinabalu | Sabah | |
| Novartis Investigative Site | Kuala Lumpur | Malaysia | |
| Novartis Investigative Site | Gdansk | Poland | |
| Novartis Investigative Site | Torun | Poland | |
| Novartis Investigative Site | Warsaw | Poland | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Singapore | Singapore |
More Novartis Pharmaceuticals trials in Poland
Other trials for the same condition
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
Active, not recruiting
A Study Evaluating TRIV-509 in Atopic Dermatitis
Active, not recruiting
A Study Evaluating APG777 in Atopic Dermatitis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07220577 on ClinicalTrials.gov ↗ ← All trials in Poland