Clareo Health | A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The study duration will be up to 36 weeks
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
