Atopic DermatitisPhase 2NCT07220577
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing GIA632 in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 28 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- GIA632
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 28 sitesin 9 countries
- Study dates
- 10 Nov 2025to 6 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
France4 sites
Novartis Investigative Site
Antony, 92160
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Martigues, 13500
Novartis Investigative Site
Nice, 06000
Malaysia4 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10450
Novartis Investigative Site
Ipoh, Perak, 30450
Novartis Investigative Site
Kota Kinabalu, Sabah, 88586
Novartis Investigative Site
Kuala Lumpur, 59100
United States3 sites
Ctr for Dermatology Clinical Res
Fremont, California, 95438
Care Access Hoboken
Hoboken, New Jersey, 07030
Aesthetics Skin Care Dermatologic Surgery
Rockville, Maryland, 20850
Bulgaria3 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, 1202
Novartis Investigative Site
Sofia, 1618
Czechia3 sites
Novartis Investigative Site
Brno, 602 00
Novartis Investigative Site
Ostrava, Poruba, 708 52
Novartis Investigative Site
Prague, 100 34
Germany3 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Hamburg, 20095
Novartis Investigative Site
Mainz, 55131
Poland3 sites
Novartis Investigative Site
Gdansk, 80-546
Novartis Investigative Site
Torun, 87-100
Novartis Investigative Site
Warsaw, 00-872
Singapore3 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 169608
Novartis Investigative Site
Singapore, 308205
Canada2 sites
Novartis Investigative Site
Québec, Quebec, G1W 4R4
Novartis Investigative Site
Toronto, Ontario, M5A 3R6
About this study
Official title: 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
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).
Read the detailed description
This is a randomized, placebo-controlled, parallel-group, non-confirmatory, investigator and participant blinded study in adult participants with moderate to severe AD.
- Conditions
- Atopic Dermatitis
- Being tested
- GIA632, Placebo
- Keywords
- Phase 2, interventional, atopic dermatitis, efficacy, safety
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIA632Drug
Active treatment arm
PlaceboOther
Placebo treatment arm
| Study group | Role | What they receive |
|---|---|---|
| GIA632 | Experimental | Active treatment arm Receives: Drug: GIA632 |
| Placebo | Placebo comparator | Placebo treatment arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
To assess the efficacy of GIA632 compared to placebo at week 16
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start10 Nov 2025
- Primary completion17 May 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220577
- Sponsor's protocol ID
- CGIA632A12201
- Other IDs
- 2025-521503-43, 2025
- Status last verified
- May 2026
- First submitted
- 22 Oct 2025
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07220577
- Acronym / sponsor ID
- CGIA632A12201
- Conditions
- Atopic Dermatitis
- Keywords
- Phase 2, interventional, atopic dermatitis, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a randomized, placebo-controlled, parallel-group, non-confirmatory, investigator and participant blinded study in adult participants with moderate to severe AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIA632 | Experimental | Drug: GIA632Active treatment arm |
| Placebo | Placebo comparator | Other: PlaceboPlacebo treatment arm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIA632Active treatment arm | Drug | GIA632 |
| PlaceboPlacebo treatment arm | Other | Placebo |
Primary outcome
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
Time frame: Baseline, Week 16
To assess the efficacy of GIA632 compared to placebo at week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Related trials for Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GIA632 in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Malaysia, United States, Bulgaria, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.