a study to investigate vaccine responses in subcutaneous amlitelimab treated atopic dermatitis participants aged 18 years and older compared with placebo

Conditions: Dermatitis Atopic

Summary: 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 (key secondary 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 9 days 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 \[river-ad\]).

the study duration will be up to 36 weeks

Eligibility criteria:
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 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 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.