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Tests treatment safety and results for Atopic Dermatitis
Official title A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07037901
What this study is testing
What is IMG-007?
IMG-007 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- Moderate-to-severe AD
- Documented history of inadequate response or lack of side effects to a stable regimen of one or more topical treatment before the Screening visit, or...
- Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of...
- Male participants must agree to use a highly effective method of contraception
- EASI score ≥16
You likely can't join if
- 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...
- Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the...
See the full eligibility criteria
- Moderate-to-severe AD
- Documented history of inadequate response or lack of side effects 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...
- 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
- 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...
- Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit
The study team makes the final eligibility decision.
Where it's taking place
- Lancaster, California, United States
- Los Angeles, California, United States
- Ocala, Florida, United States
- Tampa, Florida, United States
- Rolling Meadows, Illinois, United States
- Kew Gardens, New York, United States
- New York, New York, United States
- Woodbury, New York, United States
- Charlotte, North Carolina, United States
- Fargo, North Dakota, United States
- Columbus, Ohio, United States
- Mayfield Heights, Ohio, United States
- Portland, Oregon, United States
- Anderson, South Carolina, United States
- Southlake, Texas, United States
- Burien, Washington, United States
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Greater Sudbury, Ontario, Canada
- Mississauga, Ontario, Canada
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lancaster, California, United States; Los Angeles, California, United States; Ocala, Florida, United States; Tampa, Florida, United States; Rolling Meadows, Illinois, United States; Kew Gardens, New York, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.