Atopic DermatitisPhase 2NCT07734415
Long-term Safety and Efficacy Evaluation of IMG-007 in Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study testing IMG-007 in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Inmagene LLC at 23 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema
- What is being tested?
- IMG-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 5 Jun 2026to Mar 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Enrolling by invitation participants with moderate to severe AD who have completed IMG-007-203
Trial locations and contacts
23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 2 countries
United States16 sites
Inmagene Site 12
Anderson, South Carolina, 29621
Inmagene Site 7
Burien, Washington, 698168
Inmagene Site 20
Charlotte, North Carolina, 28277
Inmagene Site 9
Columbus, Ohio, 43213
Inmagene Site 10
Fargo, North Dakota, 58103
Inmagene Site 6
Kew Gardens, New York, 11415
Inmagene Site 1
Lancaster, California, 93534
Inmagene Site 23
Los Angeles, California, 90095
Inmagene Site 5
Mayfield Heights, Ohio, 44124
Inmagene Site 21
New York, New York, 10029
Inmagene Site 19
Ocala, Florida, 34470
Inmagene Site 3
Portland, Oregon, 97210
Inmagene Site 2
Rolling Meadows, Illinois, 60008
Inmagene Site 8
Southlake, Texas, 76092
Inmagene Site 4
Tampa, Florida, 33609
Inmagene Site 11
Woodbury, New York, 11797
Canada7 sites
Inmagene Site 17
Greater Sudbury, Ontario, P3C 1X8
Inmagene Site 13
Mississauga, Ontario, L4Y 4C5
Inmagene Site 14
Montreal, Quebec, H2X 2V1
Inmagene Site 18
North Bay, Ontario, P1B 3Z7
Inmagene Site 16
Saskatoon, Saskatchewan, S7K 2C1
Inmagene Site 15
Surrey, British Columbia, V3R 6A7
Inmagene Site 22
Vancouver, British Columbia, V6H 4B1
About this study
Official title: A Long-term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous IMG-007 in Participants of a Previous IMG-007 Moderate-To-Severe Atopic Dermatitis Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)
- Conditions
- Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema
- Being tested
- IMG-007
- Keywords
- IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis, Skin Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMG-007Drug
Participants will receive IMG-007 subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| IMG-007 Dose | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis
Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation
Measured: Baseline, Week 44
Secondary outcomes (10)
Characterize the safety of long-term treatment with IMG-007 based on body temperature (Celsius)
Measured: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on pulse rate (beats per minute)
Measured: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on respiratory rate (breaths per minute)
Measured: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on blood pressure (systolic and diastolic) (mmHg)
Measured: Baseline, Week 44
Number of Participants With Clinically Significant Abnormal (defined by rate, rhythm, morphology, and conduction abnormalities) ECG Findings (unit is number of participants).
Measured: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by hematology
Measured: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by blood chemistry
Measured: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by urinalysis
Measured: Baseline, Week 44
Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Eczema Area and Severity Index (EASI)
Measured: Baseline, Week 44
Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Measured: Baseline, Week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start5 Jun 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmagene LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734415
- Sponsor's protocol ID
- IMG-007-205
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous IMG-007 in Participants of a Previous IMG-007 Moderate-To-Severe Atopic Dermatitis Clinical Trial
- ClinicalTrials.gov ID
- NCT07734415
- Acronym / sponsor ID
- IMG-007-205
- Conditions
- Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema
- Keywords
- IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Jul 2026 (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 purpose of this study is to evaluate the safety and efficacy of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (AD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMG-007 Dose | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| IMG-007Participants will receive IMG-007 subcutaneously. | Drug | IMG-007 Dose |
Primary outcome
Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis
Time frame: Baseline, Week 44
Incidence and severity of TEAEs, including treatment-emergent SAEs, AESIs, and AEs leading to discontinuation
10 secondary outcomes
Characterize the safety of long-term treatment with IMG-007 based on body temperature (Celsius)
Time frame: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on pulse rate (beats per minute)
Time frame: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on respiratory rate (breaths per minute)
Time frame: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007 based on blood pressure (systolic and diastolic) (mmHg)
Time frame: Baseline, Week 44
Number of Participants With Clinically Significant Abnormal (defined by rate, rhythm, morphology, and conduction abnormalities) ECG Findings (unit is number of participants).
Time frame: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by hematology
Time frame: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by blood chemistry
Time frame: Baseline, Week 44
Characterize the safety of long-term treatment with IMG-007, as assessed by urinalysis
Time frame: Baseline, Week 44
Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Eczema Area and Severity Index (EASI)
Time frame: Baseline, Week 44
Evaluate the effect of long-term treatment with IMG-007 on disease activity as assessed by Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Time frame: Baseline, Week 44
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 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMG-007 in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by Inmagene LLC at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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. 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?
Evaluate the safety of long-term treatment with IMG-007 in participants with moderate-to-severe atopic dermatitis (time frame: Baseline, Week 44). 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 29 Jul 2026.