A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Inmagene LLC · NCT07037901
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–74 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 405
- US sites recruiting
- 16
- Study start
- June 17, 2025
- Record last updated
- August 12, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Being studied: IMG-007; Placebo
Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key Inclusion Criteria
- 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
Key Exclusion Criteria
- 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
Recruiting US locations
Inmagene Site 1
Lancaster, CA 93534
Inmagene Site 23
Los Angeles, CA 90095
Inmagene Site 19
Ocala, FL 34470
Inmagene Site 4
Tampa, FL 33609
Inmagene Site 2
Rolling Meadows, IL 60008
Inmagene Site 6
Kew Gardens, NY 11415
Inmagene Site 21
New York, NY 10029
Inmagene Site 11
Woodbury, NY 11797
Inmagene Site 20
Charlotte, NC 28277
Inmagene Site 10
Fargo, ND 58103
Inmagene Site 9
Columbus, OH 43213
Inmagene Site 5
Mayfield Heights, OH 44124
Inmagene Site 3
Portland, OR 97210
Inmagene Site 12
Anderson, SC 29621
Inmagene Site 8
Southlake, TX 76092
Inmagene Site 7
Burien, WA 698168
Study contacts (from the official record)
- ADAPTIVE Study Lead · (858) 345-6927 · ADAPTIVE_StudyLead@imagenebio.com
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