A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
NCT ID: NCT06015308
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2023-10-06
2026-01-16
Brief Summary
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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 \[RIVER-AD\]).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Amlitelimab
Participants will receive amlitelimab and vaccines as per protocol.
Amlitelimab
Subcutaneous injection in abdomen, outer thigh, or upper arm
Tdap vaccine
Intramuscular (IM) injection into the deltoid muscle of the upper arm
PPS vaccine
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
Placebo
Participants will receive placebo matching amlitelimab and vaccines as per protocol.
Placebo
Subcutaneous injection in abdomen, outer thigh, or upper arm
Tdap vaccine
Intramuscular (IM) injection into the deltoid muscle of the upper arm
PPS vaccine
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
Interventions
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Amlitelimab
Subcutaneous injection in abdomen, outer thigh, or upper arm
Placebo
Subcutaneous injection in abdomen, outer thigh, or upper arm
Tdap vaccine
Intramuscular (IM) injection into the deltoid muscle of the upper arm
PPS vaccine
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Clinical Research Center of Alabama - Homewood- Site Number : 8401101
Birmingham, Alabama, United States
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 Trials of Florida- Site Number : 8401023
Tampa, Florida, United States
Paradigm Clinical Research - Boise- Site Number : 8401272
Boise, Idaho, United States
Skin Sciences- Site Number : 8401039
Louisville, Kentucky, United States
Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072
Baton Rouge, Louisiana, United States
BRCR Global Gretna- Site Number : 8401243
Gretna, Louisiana, United States
Boeson Research - Missoula- Site Number : 8401269
Missoula, Montana, United States
Henderson Clinical Trials- Site Number : 8401169
Henderson, Nevada, United States
Skin Search Rochester- Site Number : 8401216
Rochester, New York, United States
Velocity Clinical Research - Durham- Site Number : 8401175
Durham, North Carolina, United States
Velocity Clinical Research - Springdale- Site Number : 8401153
Cincinnati, Ohio, United States
Velocity Clinical Research - Medford- Site Number : 8401170
Medford, Oregon, United States
Vial Health - DermDox Dermatology- Site Number : 8401031
Camp Hill, Pennsylvania, United States
Velocity Clinical Research - Providence- Site Number : 8401179
East Greenwich, Rhode Island, United States
Velocity Clinical Research - Charleston - Ashley Town Center Drive- Site Number : 8401174
Charleston, South Carolina, United States
Velocity Clinical Research - Columbia- Site Number : 8401176
Columbia, South Carolina, United States
Velocity Clinical Research - Austin- Site Number : 8401173
Cedar Park, Texas, United States
Modern Research Associates- Site Number : 8401093
Dallas, Texas, United States
Heights Dermatology & Aesthetic Center- Site Number : 8401143
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio- Site Number : 8401100
San Antonio, Texas, United States
Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026
San Antonio, Texas, United States
Stryde Research - Epiphany Dermatology- Site Number : 8401185
Southlake, Texas, United States
Ogden Clinic Mountain View (Avacare) Site Number : 8401167
Pleasant View, Utah, United States
Investigational Site Number : 1240019
Calgary, Alberta, Canada
Investigational Site Number : 1240023
Calgary, Alberta, Canada
Investigational Site Number : 1240016
Edmonton, Alberta, Canada
Investigational Site Number : 1240014
Barrie, Ontario, Canada
Investigational Site Number : 1240020
Hamilton, Ontario, Canada
Investigational Site Number : 1240017
London, Ontario, Canada
Investigational Site Number : 1240018
Newmarket, Ontario, Canada
Investigational Site Number : 1240024
Richmond Hill, Ontario, Canada
Investigational Site Number : 1240021
Toronto, Ontario, Canada
Investigational Site Number : 1240026
Toronto, Ontario, Canada
Countries
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Related Links
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SFY17915 Plain Language Results Summary
Other Identifiers
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U1111-1280-8357
Identifier Type: REGISTRY
Identifier Source: secondary_id
SFY17915
Identifier Type: -
Identifier Source: org_study_id
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