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Dermatitis AtopicPhase 2HYDRONCT06015308

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

A Phase 2 study testing Amlitelimab, Tdap vaccine and PPS vaccine in people with Dermatitis Atopic, run by Sanofi at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatitis Atopic
What is being tested?
Amlitelimab, Tdap vaccine and PPS vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
57 sitesin 2 countries
Study dates
6 Oct 2023to 16 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States47 sites

  • Orange County Clinical Trials- Site Number : 8401271

    Anaheim, California, 92801

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

    Baton Rouge, Louisiana, 70809

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

    Birmingham, Alabama, 35209

  • Daxia Trials- Site Number : 8401145

    Boca Raton, Florida, 33431

  • Paradigm Clinical Research - Boise- Site Number : 8401272

    Boise, Idaho, 83709

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

    Boynton Beach, Florida, 33436

  • Vial Health - DermDox Dermatology- Site Number : 8401031

    Camp Hill, Pennsylvania, 17011

  • Velocity Clinical Research - Austin- Site Number : 8401173

    Cedar Park, Texas, 78613

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

    Charleston, South Carolina, 29414

  • Velocity Clinical Research - Springdale- Site Number : 8401153

    Cincinnati, Ohio, 45246

  • Velocity Clinical Research - Columbia- Site Number : 8401176

    Columbia, South Carolina, 29204

  • Modern Research Associates- Site Number : 8401093

    Dallas, Texas, 75231

  • Velocity Clinical Research - Denver Site Number : 8401168

    Denver, Colorado, 80209

  • Velocity Clinical Research - Durham- Site Number : 8401175

    Durham, North Carolina, 27701

  • Velocity Clinical Research - Providence- Site Number : 8401179

    East Greenwich, Rhode Island, 02818

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

    Fort Myers, Florida, 33912

  • First OC Dermatology- Site Number : 8401025

    Fountain Valley, California, 92708

  • Center for Dermatology Clinical Research- Site Number : 8401018

    Fremont, California, 94538

  • Valley Research- Site Number : 8401097

    Fresno, California, 93720

  • BRCR Global Gretna- Site Number : 8401243

    Gretna, Louisiana, 70053

  • Henderson Clinical Trials- Site Number : 8401169

    Henderson, Nevada, 89052

  • Doral Medical Research- Site Number : 8401094

    Hialeah, Florida, 33016

  • Heights Dermatology & Aesthetic Center- Site Number : 8401143

    Houston, Texas, 77008

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

    Kendall, Florida, 33183

  • Paradigm Clinical Research Centers- Site Number : 8401273

    La Mesa, California, 91942

  • Sunwise Clinical Research- Site Number : 8401022

    Lafayette, California, 94549

  • Antelope Valley Clinical Trials- Site Number : 8401099

    Lancaster, California, 93534

  • Torrance Clinical Research- Site Number : 8401027

    Lomita, California, 90717

  • Skin Sciences- Site Number : 8401039

    Louisville, Kentucky, 40217

  • Velocity Clinical Research - Medford- Site Number : 8401170

    Medford, Oregon, 97504

  • Acevedo Clinical Research Associates- Site Number : 8401088

    Miami, Florida, 33142

  • Future Care Solution - Miami- Site Number : 8401144

    Miami, Florida, 33142

  • Sanchez Clinical Research- Site Number : 8401095

    Miami, Florida, 33157

  • Florida International Research Center- Site Number : 8401091

    Miami, Florida, 33173

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

    Miami Lakes, Florida, 33016

  • Boeson Research - Missoula- Site Number : 8401269

    Missoula, Montana, 59804

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

    Orlando, Florida, 32806

  • SEC Clinical Research- Site Number : 8401270

    Pensacola, Florida, 32501

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

    Pleasant View, Utah, 84404

  • Skin Search Rochester- Site Number : 8401216

    Rochester, New York, 14623

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

    San Antonio, Texas, 78229

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

    San Antonio, Texas, 78258

  • Clinical Science Institute- Site Number : 8401028

    Santa Monica, California, 90404

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

    Scottsdale, Arizona, 85260

  • Stryde Research - Epiphany Dermatology- Site Number : 8401185

    Southlake, Texas, 76092

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

    St. Petersburg, Florida, 33705

  • Clinical Research Trials of Florida- Site Number : 8401023

    Tampa, Florida, 33607

Other trials in United States

Canada10 sites

  • Investigational Site Number : 1240014

    Barrie, Ontario, L4M 7G1

  • Investigational Site Number : 1240019

    Calgary, Alberta, T2W 4X9

  • Investigational Site Number : 1240023

    Calgary, Alberta, T3A 2N1

  • Investigational Site Number : 1240016

    Edmonton, Alberta, T5J 3S9

  • Investigational Site Number : 1240020

    Hamilton, Ontario, L8L 3C3

  • Investigational Site Number : 1240017

    London, Ontario, N6H 5L5

  • Investigational Site Number : 1240018

    Newmarket, Ontario, L3Y 5G8

  • Investigational Site Number : 1240024

    Richmond Hill, Ontario, L4B 1A5

  • Investigational Site Number : 1240021

    Toronto, Ontario, M2N 3A6

  • Investigational Site Number : 1240026

    Toronto, Ontario, M4E 1R7

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis

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).

Read more

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]).

Read the detailed description

The study duration will be up to 36 weeks

Being tested
Amlitelimab, Placebo, Tdap vaccine, PPS vaccine
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmlitelimabDrug

    Subcutaneous injection in abdomen, outer thigh, or upper arm

  • PlaceboDrug

    Subcutaneous injection in abdomen, outer thigh, or upper arm

  • Tdap vaccineBiological

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

  • PPS vaccineBiological

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

Study groups in NCT06015308
Study groupRoleWhat they receive
AmlitelimabExperimentalParticipants will receive amlitelimab and vaccines as per protocol.
Receives: Drug: Amlitelimab; Biological: Tdap vaccine; Biological: PPS vaccine
PlaceboPlacebo comparatorParticipants will receive placebo matching amlitelimab and vaccines as per protocol.
Receives: Drug: Placebo; Biological: Tdap vaccine; Biological: PPS vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 ≤1IU/mL).

    Measured: Week 16

Secondary outcomes (8)

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

    Positive pneumococcal vaccine response is defined as a ≥2-fold increase from baseline in anti-pneumococcal antibodies (APAb) against >50% of the 23 serotypes.

    Measured: Week 16

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

    Measured: Week 0 up to Week 32

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

    Measured: Week 0 up to Week 32

  4. Percentage of participants discontinued from study treatment due to TEAEs

    Measured: Week 0 up to Week 32

  5. 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

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

    Measured: Week 16

  6. Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD using a 4-point scale; 0 (absent) to 3 (severe).

    Measured: Week 16

  7. Serum amlitelimab concentrations

    Measured: Week 0 up to Week 16

  8. Incidence of antidrug antibodies (ADAs) of amlitelimab

    Measured: Week 0 up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start6 Oct 2023
  3. Primary completion1 Oct 2025
  4. Study completion16 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015308
Sponsor's protocol ID
SFY17915
Other IDs
U1111-1280-8357
Acronym
HYDRO
Status last verified
Aug 2026
First submitted
23 Aug 2023
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amlitelimab, Tdap vaccine and PPS vaccine in people with Dermatitis Atopic, run by Sanofi at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with a positive tetanus response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06015308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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