Recruiting adults (18 years of age) for this atopic dermatitis (AD) research study.
Individuals must have:
Participants will receive investigational treatment (active study drug) or placebo via subcutaneous injection, concurrently administered with 2 non-live vaccines. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 36 weeks and involve about 7 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: December 10, 2023
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]).
Condition or Disease:
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
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
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.
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