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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

NCT06015308

CompletedPhase 2

Sponsor: Sanofi

Conditions: Dermatitis Atopic

Interventions: Amlitelimab, Placebo, Tdap vaccine, PPS vaccine

Countries: United States, Canada

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 \[RIVER-AD\]).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (57)
  • Birmingham, Alabama, United States
  • Scottsdale, Arizona, United States
  • Anaheim, California, United States
  • Fountain Valley, California, United States
  • Fremont, California, United States
  • Fresno, California, United States
  • La Mesa, California, United States
  • Lafayette, California, United States
  • Lancaster, California, United States
  • Lomita, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Boca Raton, Florida, United States
  • Boynton Beach, Florida, United States
  • Fort Myers, Florida, United States
  • Hialeah, Florida, United States
  • Kendall, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Boise, Idaho, United States
  • Louisville, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Gretna, Louisiana, United States
  • + 27 more on CT.gov