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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis Atopic

In brief

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 \[RIVER-AD\]).

Key facts

Study ID

NCT06015308

Run by

Sanofi

People needed

224

Starts

2023-10-06

Expected to finish

2026-01-16

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Center for Dermatology and Plastic Surgery- Site Number : 8401119 — Scottsdale, Arizona, United States
• Orange County Clinical Trials- Site Number : 8401271 — Anaheim, California, United States
• First OC Dermatology- Site Number : 8401025 — Fountain Valley, California, United States
• Center for Dermatology Clinical Research- Site Number : 8401018 — Fremont, California, United States
• Valley Research- Site Number : 8401097 — Fresno, California, United States
• Paradigm Clinical Research Centers- Site Number : 8401273 — La Mesa, California, United States
• Sunwise Clinical Research- Site Number : 8401022 — Lafayette, California, United States
• Antelope Valley Clinical Trials- Site Number : 8401099 — Lancaster, California, United States
• Torrance Clinical Research- Site Number : 8401027 — Lomita, California, United States
• Clinical Science Institute- Site Number : 8401028 — Santa Monica, California, United States
• Velocity Clinical Research - Denver Site Number : 8401168 — Denver, Colorado, United States
• Daxia Trials- Site Number : 8401145 — Boca Raton, Florida, United States
• Encore Medical Research of Boynton Beach- Site Number : 8401030 — Boynton Beach, Florida, United States
• Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111 — Fort Myers, Florida, United States
• Doral Medical Research- Site Number : 8401094 — Hialeah, Florida, United States
• C&R Research Services - Kendall- Site Number : 8401029 — Kendall, Florida, United States
• Acevedo Clinical Research Associates- Site Number : 8401088 — Miami, Florida, United States
• Future Care Solution - Miami- Site Number : 8401144 — Miami, Florida, United States
• Sanchez Clinical Research- Site Number : 8401095 — Miami, Florida, United States
• Florida International Research Center- Site Number : 8401091 — Miami, Florida, United States
• Wellness Clinical Research - Miami Lakes- Site Number : 8401109 — Miami Lakes, Florida, United States
• K2 South Orlando - South Orange Avenue- Site Number : 8401268 — Orlando, Florida, United States
• SEC Clinical Research- Site Number : 8401270 — Pensacola, Florida, United States
• Global Clinical Professionals (GCP)- Site Number : 8401045 — St. Petersburg, Florida, United States
• Clinical Research Center of Alabama - Homewood- Site Number : 8401101 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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