A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
Study of Vaccine Responses in Adults with Atopic Dermatitis
Study Overview
This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD).
The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (primary endpoint).
Study details include:
The study duration will be up to 36 weeks (for participants not entering the LTS17367 [RIVER-AD]).
The screening period will be 2 to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 [RIVER-AD]).
Study Details
The study duration will be up to 36 weeks
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Dermatitis Atopic
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Participants must be 18 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
- Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit
- Eczema area and severity index (EASI) score of 12 or higher at baseline
- AD involvement of 10% or more of body surface area (BSA) at baseline
- Able and willing to comply with requested study visits and procedures
- Body weight ≥40 kg and ≤150 kg
Exclusion Criteria:
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening
- Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening
- Prior receipt of two or more doses of Pneumovax 23 at any time
- Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening
- Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
- Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
- Known history of or suspected significant current immunosuppression
- Any malignancies or history of malignancies prior to baseline (excluding in situ excised and cured cervical carcinoma, non-melanoma skin cancer excised and cured >3 years prior to baseline)
- History of solid organ or stem cell transplant
- Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline
- Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
- Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
This study investigates the effects of an investigational medication on vaccine responses in adults with moderate-to-severe atopic dermatitis, a skin condition that causes itchy and inflamed patches of skin. The purpose of this study is to compare immune responses to vaccines given alongside the investigational medication versus a placebo. Participants will receive either the investigational medication or a placebo along with vaccines for tetanus, diphtheria, and pertussis (Tdap) and pneumococcal infections.
Participants will undergo various study procedures, including receiving the vaccines and the investigational medication or placebo. The study will measure how well the body responds to these vaccines by looking at the percentage of participants who develop a positive response to the tetanus and pneumococcal vaccines by Week 16. Complex medical terms such as placebo are explained: it is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Who can participate: Adults aged 18 and older with moderate-to-severe atopic dermatitis for at least one year can participate. Key eligibility factors include a history of inadequate response to topical treatments and specific scores on atopic dermatitis assessments. Participants must weigh between 40 kg and 150 kg.
- Study details: Participants will receive either the investigational medication or a placebo along with the vaccines. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will be monitored for immune responses to the vaccines and any side effects.
- Study Timelines and Visits: The study will last up to 36 weeks. The study requires 7 visits.
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