A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

Korábbi kezelés

• 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
• Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline

Más betegség

• Known history of or suspected significant current immunosuppression
• History of solid organ or stem cell transplant
• 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.

Életkor

• Any malignancies or history of malignancies prior to baseline (excluding non-melanoma skin cancer excised and cured \>5 years prior to baseline)

Egyéb

• Skin co-morbidity that would adversely affect the ability to undertake AD assessments

• 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