BridgeMD
Tests treatment safety and results for Dermatitis Atopic
Official title A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
ClinicalTrials.gov ID: NCT06241118
What this study is testing
What is Amlitelimab?
Amlitelimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for dermatitis atopic.
Also referred to as SAR445229.
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
- This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.
- Phase 3: a large, late-stage study
- 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 12 and older
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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
- v-IGA-AD of 3 or 4 at baseline visit
- EASI score of 16 or higher at baseline
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- 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...
- 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
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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
- 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
- Participants are excluded from the study if any of the following criteria apply:
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- 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
- 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
- History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP) The above information is not intended to contain all considerations relevant to a potential participation in a...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- North Little Rock, Arkansas, United States
- Encino, California, United States
- Fremont, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- San Diego, California, United States
- Wheat Ridge, Colorado, United States
- Boynton Beach, Florida, United States
- Doral, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- Bowling Green, Kentucky, United States
+ 104 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; North Little Rock, Arkansas, United States; Encino, California, United States; Fremont, California, United States; Long Beach, California, United States and 118 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.