BridgeMD
A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis (ADAPTIVE)
EU CTIS ID: 2024-520117-50-00
What this study is testing
To evaluate the effect of different dose regimens of IMG-007, compared to placebo, on disease activity, as measured by Eczema Area and Severity Index (EASI) in participants with moderate to-severe atopic dermatitis (AD), at the end of the placebo-controlled treatment period
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Male or female aged ≥ 18 and < 75 years
- • Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
- • Diagnosis of AD (according to the American Academy of Dermatology Consensus diagnostic criteria) that has been present for at least 1 year before the Screening visit
- • Active moderate-to-severe AD
- • Documented history of inadequate response to or lack of tolerability of, as assessed by the investigator, a stable regimen (≥ 4 weeks) of one or more topical treatments, e.g., topical corticosteroids (TCSs) and/or topical calcineurin inhibitors (TCIs) before the Screening visit, or for whom topical treatments are otherwise inadvisable
- • Agree to apply a stable dose of a non-medicated emollient (moisturizer)
You likely can't join if
- • Severe cardiovascular, pulmonary, renal, autoimmune, or metabolic illness(es), or any other acute or chronic medical or psychiatric condition or laboratory abnormality
- • History of clinically significant abnormal laboratory values
- • Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit
- • Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB blood test
- • History of untreated or inadequately treated TB infection
- • Active infection (including skin infection) requiring treatment with topical or systemic antibiotics, antivirals, antifungals, antiparasitic or antiprotozoals within 2 weeks prior to the Baseline (Day 1) visit.
See the full eligibility criteria
- • Male or female aged ≥ 18 and < 75 years
- • Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
- • Diagnosis of AD (according to the American Academy of Dermatology Consensus diagnostic criteria) that has been present for at least 1 year before the Screening visit
- • Active moderate-to-severe AD
- • Documented history of inadequate response to or lack of tolerability of, as assessed by the investigator, a stable regimen (≥ 4 weeks) of one or more topical treatments, e.g., topical corticosteroids (TCSs) and/or topical calcineurin inhibitors (TCIs) before the Screening visit, or for whom topical treatments are otherwise inadvisable
- • Agree to apply a stable dose of a non-medicated emollient (moisturizer)
- • Female participants must not be pregnant or breastfeeding and must meet at least one of the following conditions: a) Not of childbearing potential, OR b) Of childbearing potential and agree to use a highly effective method of contraception
- • Male participants must agree to use a highly effective method of contraception or must be surgically sterilized
- • Severe cardiovascular, pulmonary, renal, autoimmune, or metabolic illness(es), or any other acute or chronic medical or psychiatric condition or laboratory abnormality
- • History of clinically significant abnormal laboratory values
- • Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit
- • Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB blood test
- • History of untreated or inadequately treated TB infection
- • Active infection (including skin infection) requiring treatment with topical or systemic antibiotics, antivirals, antifungals, antiparasitic or antiprotozoals within 2 weeks prior to the Baseline (Day 1) visit.
- • Active unstable (e.g., in an acute flare) pruritic skin conditions or other skin diseases in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgment
- • Previous participation in a study using IMG-007 as the study treatment
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. 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 EU CTIS; the study team decides eligibility.