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]).
Description
The study duration will be up to 36 weeks
Eligibility
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.