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
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.