Atopic DermatitisPhase 2ADAPTIVENCT07037901
A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult 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 30 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 74 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?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 17 Jun 2025to Aug 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-to-severe AD
- Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable
- Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception
- Male participants must agree to use a highly effective method of contraception
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization
Who cannot join
- Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Evidence of active or latent tuberculosis (TB)
- History of untreated or inadequately treated TB infection
- Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
- Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement
- Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study
- Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit
Trial locations and contacts
30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 4 countries
United States16 sites, 16 recruiting
- Recruiting
Inmagene Site 12
Anderson, South Carolina, 29621
- Recruiting
Inmagene Site 7
Burien, Washington, 698168
- Recruiting
Inmagene Site 20
Charlotte, North Carolina, 28277
- Recruiting
Inmagene Site 9
Columbus, Ohio, 43213
- Recruiting
Inmagene Site 10
Fargo, North Dakota, 58103
- Recruiting
Inmagene Site 6
Kew Gardens, New York, 11415
- Recruiting
Inmagene Site 1
Lancaster, California, 93534
- Recruiting
Inmagene Site 23
Los Angeles, California, 90095
- Recruiting
Inmagene Site 5
Mayfield Heights, Ohio, 44124
- Recruiting
Inmagene Site 21
New York, New York, 10029
- Recruiting
Inmagene Site 19
Ocala, Florida, 34470
- Recruiting
Inmagene Site 3
Portland, Oregon, 97210
- Recruiting
Inmagene Site 2
Rolling Meadows, Illinois, 60008
- Recruiting
Inmagene Site 8
Southlake, Texas, 76092
- Recruiting
Inmagene Site 4
Tampa, Florida, 33609
- Recruiting
Inmagene Site 11
Woodbury, New York, 11797
Canada7 sites, 7 recruiting
- Recruiting
Inmagene Site 17
Greater Sudbury, Ontario, P3C 1X8
- Recruiting
Inmagene Site 13
Mississauga, Ontario, L4Y 4C5
- Recruiting
Inmagene Site 14
Montreal, Quebec, H2X 2V1
- Recruiting
Inmagene Site 18
North Bay, Ontario, P1B 3Z7
- Recruiting
Inmagene Site 16
Saskatoon, Saskatchewan, S7K 2C1
- Recruiting
Inmagene Site 15
Surrey, British Columbia, V3R 6A7
- Recruiting
Inmagene Site 22
Vancouver, British Columbia, V6H 4B1
Australia5 sites, 5 recruiting
- Not yet recruiting
Inmagene Site 26
Benowa, Queensland, 4217
- Not yet recruiting
Inmagene Site 27
Carlton, Victoria, 3053
- Not yet recruiting
Inmagene Site 28
Liverpool, New South Wales, 2170
- Not yet recruiting
Inmagene Site 24
Mitcham, Victoria, 3132
- Not yet recruiting
Inmagene Site 25
Woden, Australian Capital Territory, 2606
New Zealand2 sites, 2 recruiting
- Not yet recruiting
Inmagene Site 30
Auckland, 1051
- Not yet recruiting
Inmagene Site 29
Hamilton, Waikato Region, 3204
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Read the detailed description
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
- Conditions
- Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema
- Being tested
- IMG-007, Placebo
- 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.
PlaceboDrug
Participants will receive a placebo subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| IMG-007 Dose 1 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| IMG-007 Dose 2 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| IMG-007 Dose 3 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| IMG-007 Dose 4 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| IMG-007 Dose 5 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| IMG-007 Dose 6 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| IMG-007 Dose 7 | Experimental | Subcutaneous injection as per protocol. Receives: Drug: IMG-007 |
| Placebo Crossover Dose 1 | Placebo comparator | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. Receives: Drug: IMG-007; Drug: Placebo |
| Placebo Crossover Dose 2 | Placebo comparator | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. Receives: Drug: IMG-007; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in EASI at Week 24
Measured: Baseline, Week 24
Secondary outcomes (4)
Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24
Measured: Baseline, Week 24
Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24
Measured: Baseline, Week 24
Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24
Measured: Baseline, Week 24
Incidence and severity of TEAE including treatment-emergent SAEs
Measured: Baseline, End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start17 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionAug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 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
- NCT07037901
- Sponsor's protocol ID
- IMG-007-203
- Acronym
- ADAPTIVE
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07037901
- Acronym / sponsor ID
- ADAPTIVE / IMG-007-203
- 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
- Recruiting
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 26 Jun 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 purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Detailed description
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| IMG-007 Dose 1 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| IMG-007 Dose 2 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| IMG-007 Dose 3 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| IMG-007 Dose 4 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| IMG-007 Dose 5 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| IMG-007 Dose 6 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| IMG-007 Dose 7 | Experimental | Drug: IMG-007Subcutaneous injection as per protocol. |
| Placebo Crossover Dose 1 | Placebo comparator | Drug: IMG-007, Drug: PlaceboSubcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
| Placebo Crossover Dose 2 | Placebo comparator | Drug: IMG-007, Drug: PlaceboSubcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate-to-severe AD
- Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable
- Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception
- Male participants must agree to use a highly effective method of contraception
- EASI score ≥16
Key exclusion criteria (7 listed)
- Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Evidence of active or latent tuberculosis (TB)
- History of untreated or inadequately treated TB infection
- Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
- Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement
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 1, IMG-007 Dose 2, IMG-007 Dose 3, IMG-007 Dose 4, IMG-007 Dose 5, IMG-007 Dose 6, IMG-007 Dose 7, Placebo Crossover Dose 1, Placebo Crossover Dose 2 |
| PlaceboParticipants will receive a placebo subcutaneously. | Drug | Placebo Crossover Dose 1, Placebo Crossover Dose 2 |
Primary outcome
Mean percent change from baseline in EASI at Week 24
Time frame: Baseline, Week 24
4 secondary outcomes
Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24
Time frame: Baseline, Week 24
Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24
Time frame: Baseline, Week 24
Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24
Time frame: Baseline, Week 24
Incidence and severity of TEAE including treatment-emergent SAEs
Time frame: Baseline, End of Study
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 12 Aug 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.
30 sites in 4 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 30 sites in 4 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 8 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Australia, New Zealand. 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?
Contact ADAPTIVE Study Lead ((858) 345-6927, ADAPTIVE_StudyLead@imagenebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent change from baseline in EASI at Week 24 (time frame: Baseline, Week 24). 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 12 Aug 2026.