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

Research Study on Immune Responses to Vaccines in Atopic Dermatitis Patients Treated with Investigational Medication

Not Recruiting
18 years or above
All
Phase 2
224 participants needed

Study 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 (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]).

Study Details

The study duration will be up to 36 weeks

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatitis Atopic
  • Age: 18 years or above
  • Gender: All

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.

The purpose of this study is to investigate the immune responses to vaccines in adults with moderate-to-severe atopic dermatitis who are treated with an investigational medication compared to a placebo. This study will focus on how the body's immune system responds to two vaccines: Boostrix, which protects against tetanus, diphtheria, and pertussis, and Pneumovax 23, which protects against pneumococcal infections.

Participants will be randomly assigned to receive either the investigational medication or a placebo. The study will measure the percentage of participants who achieve a positive immune response to the vaccines at Week 16. Participants will receive the vaccines while continuing their assigned treatment, and their immune responses will be monitored through blood tests. The study will also assess the safety of receiving these vaccines alongside the investigational medication.

  • Who can participate: Adults aged 18 years and older with a diagnosis of atopic dermatitis for at least one year and moderate-to-severe symptoms may participate. Participants must have a history of inadequate response to topical treatments, a body weight between 40 kg and 150 kg, and be willing to comply with study procedures.
  • Study details: Participants will receive either an investigational medication or a placebo, alongside routine vaccinations for tetanus, diphtheria, pertussis, and pneumococcal infections. The study will monitor immune responses to these vaccines and assess the safety of concurrent administration with the investigational medication.
  • Study timelines and visits: The study will last up to 36 weeks. The study requires 7 visits.
Updated on 30 Oct 2025. Study ID: NCT06015308