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

NCT06015308 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: SFY17915U1111-1280-8357
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 57

Brief Summary

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 \[RIVER-AD\]).

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with a positive tetanus response at Week 16

  Positive tetanus response is defined as ≥2.5 IU/mL in anti-tetanus immunoglobulin G \[IgG\] titer for participants with a pre-vaccination baseline \[Week 12\] tetanus antibody titer of \>1 IU/mL or a titer ≥ 3-fold increase for participants with a pre-vaccination titer of ≤1 IU/mL).

  Week 16

Secondary Outcomes (8)

• Percentage of participants with a positive pneumococcal vaccine response at Week 16

  Week 16

• Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)

  Week 0 up to Week 32

• Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments

  Week 0 up to Week 32

• Percentage of participants discontinued from study treatment due to TEAEs

  Week 0 up to Week 32

• Proportion of participants with validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline at Week 16

  Week 16

Study Arms (2)

Amlitelimab

EXPERIMENTAL

Participants will receive amlitelimab and vaccines as per protocol.

Drug: Amlitelimab; Biological: Tdap vaccine; Biological: PPS vaccine

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching amlitelimab and vaccines as per protocol.

Drug: Placebo; Biological: Tdap vaccine; Biological: PPS vaccine

Interventions

Tdap vaccine BIOLOGICAL

Intramuscular (IM) injection into the deltoid muscle of the upper arm

Amlitelimab; Placebo

PPS vaccine BIOLOGICAL

Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm

Amlitelimab; Placebo

Placebo DRUG

Subcutaneous injection in abdomen, outer thigh, or upper arm

Placebo

Amlitelimab DRUG

Subcutaneous injection in abdomen, outer thigh, or upper arm

Amlitelimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (57)

Clinical Research Center of Alabama - Homewood- Site Number : 8401101

Birmingham, Alabama, 35209, United States

Location

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, 85260, United States

Location

Orange County Clinical Trials- Site Number : 8401271

Anaheim, California, 92801, United States

Location

First OC Dermatology- Site Number : 8401025

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research- Site Number : 8401018

Fremont, California, 94538, United States

Location

Valley Research- Site Number : 8401097

Fresno, California, 93720, United States

Location

Paradigm Clinical Research Centers- Site Number : 8401273

La Mesa, California, 91942, United States

Location

Sunwise Clinical Research- Site Number : 8401022

Lafayette, California, 94549, United States

Location

Antelope Valley Clinical Trials- Site Number : 8401099

Lancaster, California, 93534, United States

Location

Torrance Clinical Research- Site Number : 8401027

Lomita, California, 90717, United States

Location

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, 90404, United States

Location

Velocity Clinical Research - Denver Site Number : 8401168

Denver, Colorado, 80209, United States

Location

Daxia Trials- Site Number : 8401145

Boca Raton, Florida, 33431, United States

Location

Encore Medical Research of Boynton Beach- Site Number : 8401030

Boynton Beach, Florida, 33436, United States

Location

Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111

Fort Myers, Florida, 33912, United States

Location

Doral Medical Research- Site Number : 8401094

Hialeah, Florida, 33016, United States

Location

C&R Research Services - Kendall- Site Number : 8401029

Kendall, Florida, 33183, United States

Location

Acevedo Clinical Research Associates- Site Number : 8401088

Miami, Florida, 33142, United States

Location

Future Care Solution - Miami- Site Number : 8401144

Miami, Florida, 33142, United States

Location

Sanchez Clinical Research- Site Number : 8401095

Miami, Florida, 33157, United States

Location

Florida International Research Center- Site Number : 8401091

Miami, Florida, 33173, United States

Location

Wellness Clinical Research - Miami Lakes- Site Number : 8401109

Miami Lakes, Florida, 33016, United States

Location

K2 South Orlando - South Orange Avenue- Site Number : 8401268

Orlando, Florida, 32806, United States

Location

SEC Clinical Research- Site Number : 8401270

Pensacola, Florida, 32501, United States

Location

Global Clinical Professionals (GCP)- Site Number : 8401045

St. Petersburg, Florida, 33705, United States

Location

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, 33607, United States

Location

Paradigm Clinical Research - Boise- Site Number : 8401272

Boise, Idaho, 83709, United States

Location

Skin Sciences- Site Number : 8401039

Louisville, Kentucky, 40217, United States

Location

Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072

Baton Rouge, Louisiana, 70809, United States

Location

BRCR Global Gretna- Site Number : 8401243

Gretna, Louisiana, 70053, United States

Location

Boeson Research - Missoula- Site Number : 8401269

Missoula, Montana, 59804, United States

Location

Henderson Clinical Trials- Site Number : 8401169

Henderson, Nevada, 89052, United States

Location

Skin Search Rochester- Site Number : 8401216

Rochester, New York, 14623, United States

Location

Velocity Clinical Research - Durham- Site Number : 8401175

Durham, North Carolina, 27701, United States

Location

Velocity Clinical Research - Springdale- Site Number : 8401153

Cincinnati, Ohio, 45246, United States

Location

Velocity Clinical Research - Medford- Site Number : 8401170

Medford, Oregon, 97504, United States

Location

Vial Health - DermDox Dermatology- Site Number : 8401031

Camp Hill, Pennsylvania, 17011, United States

Location

Velocity Clinical Research - Providence- Site Number : 8401179

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research - Charleston - Ashley Town Center Drive- Site Number : 8401174

Charleston, South Carolina, 29414, United States

Location

Velocity Clinical Research - Columbia- Site Number : 8401176

Columbia, South Carolina, 29204, United States

Location

Velocity Clinical Research - Austin- Site Number : 8401173

Cedar Park, Texas, 78613, United States

Location

Modern Research Associates- Site Number : 8401093

Dallas, Texas, 75231, United States

Location

Heights Dermatology & Aesthetic Center- Site Number : 8401143

Houston, Texas, 77008, United States

Location

Dermatology Clinical Research Center of San Antonio- Site Number : 8401100

San Antonio, Texas, 78229, United States

Location

Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026

San Antonio, Texas, 78258, United States

Location

Stryde Research - Epiphany Dermatology- Site Number : 8401185

Southlake, Texas, 76092, United States

Location

Ogden Clinic Mountain View (Avacare) Site Number : 8401167

Pleasant View, Utah, 84404, United States

Location

Investigational Site Number : 1240019

Calgary, Alberta, T2W 4X9, Canada

Location

Investigational Site Number : 1240023

Calgary, Alberta, T3A 2N1, Canada

Location

Investigational Site Number : 1240016

Edmonton, Alberta, T5J 3S9, Canada

Location

Investigational Site Number : 1240014

Barrie, Ontario, L4M 7G1, Canada

Location

Investigational Site Number : 1240020

Hamilton, Ontario, L8L 3C3, Canada

Location

Investigational Site Number : 1240017

London, Ontario, N6H 5L5, Canada

Location

Investigational Site Number : 1240018

Newmarket, Ontario, L3Y 5G8, Canada

Location

Investigational Site Number : 1240024

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Investigational Site Number : 1240021

Toronto, Ontario, M2N 3A6, Canada

Location

Investigational Site Number : 1240026

Toronto, Ontario, M4E 1R7, Canada

Location

Related Links

• SFY17915 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 6, 2023
• Primary Completion: October 1, 2025
• Study Completion: January 16, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (10); US (47)