A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Recruiting · NCT07037901 · Interventional (participants receive a specific treatment) · Lead sponsor: Inmagene LLC
View the official record on ClinicalTrials.gov →Interventions studied
IMG-007Placebo
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
30 locations listed across 11 US states.
- Inmagene Site 1 - Lancaster, California, United States
- Inmagene Site 23 - Los Angeles, California, United States
- Inmagene Site 19 - Ocala, Florida, United States
- Inmagene Site 4 - Tampa, Florida, United States
- Inmagene Site 2 - Rolling Meadows, Illinois, United States
- Inmagene Site 6 - Kew Gardens, New York, United States
- Inmagene Site 21 - New York, New York, United States
- Inmagene Site 11 - Woodbury, New York, United States
- Inmagene Site 20 - Charlotte, North Carolina, United States
- Inmagene Site 10 - Fargo, North Dakota, United States
- Inmagene Site 9 - Columbus, Ohio, United States
- Inmagene Site 5 - Mayfield Heights, Ohio, United States
- Inmagene Site 3 - Portland, Oregon, United States
- Inmagene Site 12 - Anderson, South Carolina, United States
- Inmagene Site 8 - Southlake, Texas, United States
- Inmagene Site 7 - Burien, Washington, United States
- Inmagene Site 30 - Auckland, New Zealand
- Inmagene Site 25 - Woden, Australian Capital Territory, Australia
- Inmagene Site 15 - Surrey, British Columbia, Canada
- Inmagene Site 22 - Vancouver, British Columbia, Canada
- Inmagene Site 28 - Liverpool, New South Wales, Australia
- Inmagene Site 17 - Greater Sudbury, Ontario, Canada
- Inmagene Site 13 - Mississauga, Ontario, Canada
- Inmagene Site 18 - North Bay, Ontario, Canada
- Inmagene Site 14 - Montreal, Quebec, Canada
- Inmagene Site 26 - Benowa, Queensland, Australia
- Inmagene Site 16 - Saskatoon, Saskatchewan, Canada
- Inmagene Site 27 - Carlton, Victoria, Australia
- Inmagene Site 24 - Mitcham, Victoria, Australia
- Inmagene Site 29 - Hamilton, Waikato Region, New Zealand