BridgeMD
A study to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in participants aged 12 years and older with moderate-to-severe atopic dermatitis
EU CTIS ID: 2022-501196-41-00
What this study is testing
To demonstrate the efficacy of amlitelimab monotherapy in comparison to placebo in participants aged 12 years and older with moderate-to-severe atopic dermatitis (AD)
- Therapeutic confirmatory (Phase III)
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
- Participants must be 12 years of age (when signing informed consent form)
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
- Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or higher at baseline
- AD involvement of 10% or more of BSA at baseline
You likely can't join if
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
- Known history of or suspected significant current immunosuppression
- Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
- History of solid organ or stem cell transplant
- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections)
See the full eligibility criteria
- Participants must be 12 years of age (when signing informed consent form)
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
- Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or higher at baseline
- AD involvement of 10% or more of BSA at baseline
- Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
- Able and willing to comply with requested study visits and procedures
- Body weight ≥25 kg
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
- Known history of or suspected significant current immunosuppression
- Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
- History of solid organ or stem cell transplant
- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections)
- Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
- Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
- In the Investigator’s opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- India
- Brazil
- Australia
- Taiwan
- Israel
- United States
- China
- Argentina
- Chile
- 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; India; Brazil; Australia; Taiwan; Israel and 5 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 EU CTIS; the study team decides eligibility.