Atopic DermatitisPhase 1/2NCT05984784
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)
A Phase 1/2 study testing IMG-007 in people with Atopic Dermatitis and Moderate-to-severe Atopic Dermatitis, run by Inmagene LLC at 12 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD
- 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
- 13 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 9 Aug 2023to 26 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female aged ≥ 18 and < 75 years.
- 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.
Who cannot join
- Known 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 at the Screening visit.
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Medical Research Center of Miami II Inc
Miami, Florida, 33134
Markowitz Medical, LLC
New York, New York, 10128
Amicis Research Center
Northridge, California, 91324
Central Sooner Research
Oklahoma City, Oklahoma, 73170
Optimal Research Sites
Orange City, Florida, 32763
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103
USF Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
Revival Research Institute, LLC
Troy, Michigan, 48084
Amicis Research Center
Valencia, California, 91355
Canada3 sites
Brunswick Dermatology Center
Fredericton, New Brunswick, E3B 1G9
DermEffects
London, Ontario, N6H 5L5
Centre de Recherche Saint-Louis (Québec)
Québec, G1W4R4
About this study
Official title: A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.
Read the detailed description
This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
- Conditions
- Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD
- Being tested
- Placebo, IMG-007
- Keywords
- IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Drug: Placebo Intravenous Infusion
IMG-007Drug
Drug: IMG-007 Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 IMG-007 Dose 1 | Experimental | IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks Receives: Drug: IMG-007 |
| Cohort 2 IMG-007 Dose 2 | Experimental | IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks Receives: Drug: IMG-007 |
| Placebo | Placebo comparator | Placebo will be administered intravenously 3 times over 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Adverse Events in Participants
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
Measured: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
Secondary outcomes (2)
Pharmacokinetic Characterization
To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in AD participants
Measured: Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).
Evaluation of Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) is a validated composite scoring system assessed by the investigator based on the body area involved in each of the four body regions (head and neck, upper limbs, lower limbs, and trunk) and the average severity of each of the four key signs of AD (erythema, edema/papulation, excoriation, and lichenification) based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total EASI score ranges from 0 (clear or no eczema) to 72 (maximum severity), with higher values indicating more severe and/or extensive disease.
Measured: Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start9 Aug 2023
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Why it stopped: Cohort 1 was completed. Cohort 2 was cancelled because data from Cohort 1 provided sufficient information for further development decision. No safety concerns were noted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmagene LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984784
- Sponsor's protocol ID
- IMG-007-201
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 2023
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data to be disclosed for primary and secondary endpoints.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05984784
- Acronym / sponsor ID
- IMG-007-201
- Conditions
- Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD
- Keywords
- IMG-007, Atopic Dermatitis, Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Immune System Diseases, Dermatologic Agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cohort 1 was completed. Cohort 2 was cancelled because data from Cohort 1 provided sufficient information for further development decision. No safety concerns were noted.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.
Detailed description
This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 IMG-007 Dose 1 | Experimental | Drug: IMG-007IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks |
| Cohort 2 IMG-007 Dose 2 | Experimental | Drug: IMG-007IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered intravenously 3 times over 4 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged ≥ 18 and < 75 years.
- 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.
Key exclusion criteria (6 listed)
- Known 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 at the Screening visit.
- 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 |
|---|---|---|
| PlaceboDrug: Placebo Intravenous Infusion | Drug | Placebo |
| IMG-007Drug: IMG-007 Intravenous Infusion | Drug | Cohort 1 IMG-007 Dose 1, Cohort 2 IMG-007 Dose 2 |
Primary outcome
Evaluation of Adverse Events in Participants
Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)
2 secondary outcomes
Pharmacokinetic Characterization
Time frame: Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).
Evaluation of Eczema Area and Severity Index (EASI)
Time frame: Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Data to be disclosed for primary and secondary endpoints.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMG-007 in people with Atopic Dermatitis and Moderate-to-severe Atopic Dermatitis, run by Inmagene LLC at 12 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?
The sponsor lists 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Adverse Events in Participants (time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.). 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 6 Nov 2025.