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Eczema Drug's impact on vaccines under microscope

NCT ID NCT06015308

Knowledge-focused Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study looked at how well vaccines work in adults with moderate-to-severe eczema who are taking amlitelimab, an experimental drug. About 224 participants received either amlitelimab or a placebo along with tetanus and pneumonia vaccines. The goal was to see if the drug changes the body's ability to build immunity from these vaccines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

224 people

The number who actually took part.

Started

Oct 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatitis, atopic

Contacts and locations

Locations

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida, 33142, United States

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

    Fort Myers, Florida, 33912, United States

  • Antelope Valley Clinical Trials- Site Number : 8401099

    Lancaster, California, 93534, United States

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana, 70053, United States

  • Boeson Research - Missoula- Site Number : 8401269

    Missoula, Montana, 59804, United States

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

    Kendall, Florida, 33183, United States

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538, United States

  • Center for Dermatology and Plastic Surgery- Site Number : 8401119

    Scottsdale, Arizona, 85260, United States

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

    Birmingham, Alabama, 35209, United States

  • Clinical Research Trials of Florida- Site Number : 8401023

    Tampa, Florida, 33607, United States

  • Clinical Science Institute- Site Number : 8401028

    Santa Monica, California, 90404, United States

  • Daxia Trials- Site Number : 8401145

    Boca Raton, Florida, 33431, United States

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

    San Antonio, Texas, 78229, United States

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

    San Antonio, Texas, 78258, United States

  • Doral Medical Research- Site Number : 8401094

    Hialeah, Florida, 33016, United States

  • Encore Medical Research of Boynton Beach- Site Number : 8401030

    Boynton Beach, Florida, 33436, United States

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California, 92708, United States

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida, 33173, United States

  • Future Care Solution - Miami- Site Number : 8401144

    Miami, Florida, 33142, United States

  • Global Clinical Professionals (GCP)- Site Number : 8401045

    St. Petersburg, Florida, 33705, United States

  • Heights Dermatology & Aesthetic Center- Site Number : 8401143

    Houston, Texas, 77008, United States

  • Henderson Clinical Trials- Site Number : 8401169

    Henderson, Nevada, 89052, United States

  • Investigational Site Number : 1240014

    Barrie, Ontario, L4M 7G1, Canada

  • Investigational Site Number : 1240016

    Edmonton, Alberta, T5J 3S9, Canada

  • Investigational Site Number : 1240017

    London, Ontario, N6H 5L5, Canada

  • Investigational Site Number : 1240018

    Newmarket, Ontario, L3Y 5G8, Canada

  • Investigational Site Number : 1240019

    Calgary, Alberta, T2W 4X9, Canada

  • Investigational Site Number : 1240020

    Hamilton, Ontario, L8L 3C3, Canada

  • Investigational Site Number : 1240021

    Toronto, Ontario, M2N 3A6, Canada

  • Investigational Site Number : 1240023

    Calgary, Alberta, T3A 2N1, Canada

  • Investigational Site Number : 1240024

    Richmond Hill, Ontario, L4B 1A5, Canada

  • Investigational Site Number : 1240026

    Toronto, Ontario, M4E 1R7, Canada

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

    Orlando, Florida, 32806, United States

  • Modern Research Associates- Site Number : 8401093

    Dallas, Texas, 75231, United States

  • Ogden Clinic Mountain View (Avacare) Site Number : 8401167

    Pleasant View, Utah, 84404, United States

  • Orange County Clinical Trials- Site Number : 8401271

    Anaheim, California, 92801, United States

  • Paradigm Clinical Research - Boise- Site Number : 8401272

    Boise, Idaho, 83709, United States

  • Paradigm Clinical Research Centers- Site Number : 8401273

    La Mesa, California, 91942, United States

  • SEC Clinical Research- Site Number : 8401270

    Pensacola, Florida, 32501, United States

  • Sanchez Clinical Research- Site Number : 8401095

    Miami, Florida, 33157, United States

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky, 40217, United States

  • Skin Search Rochester- Site Number : 8401216

    Rochester, New York, 14623, United States

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas, 76092, United States

  • Sunwise Clinical Research- Site Number : 8401022

    Lafayette, California, 94549, United States

  • Torrance Clinical Research- Site Number : 8401027

    Lomita, California, 90717, United States

  • Valley Research- Site Number : 8401097

    Fresno, California, 93720, United States

  • Velocity Clinical Research - Austin- Site Number : 8401173

    Cedar Park, Texas, 78613, United States

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

    Charleston, South Carolina, 29414, United States

  • Velocity Clinical Research - Columbia- Site Number : 8401176

    Columbia, South Carolina, 29204, United States

  • Velocity Clinical Research - Denver Site Number : 8401168

    Denver, Colorado, 80209, United States

  • Velocity Clinical Research - Durham- Site Number : 8401175

    Durham, North Carolina, 27701, United States

  • Velocity Clinical Research - Medford- Site Number : 8401170

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Providence- Site Number : 8401179

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Springdale- Site Number : 8401153

    Cincinnati, Ohio, 45246, United States

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

    Baton Rouge, Louisiana, 70809, United States

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011, United States

  • Wellness Clinical Research - Miami Lakes- Site Number : 8401109

    Miami Lakes, Florida, 33016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.