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Cancer Vaccine

Amlitelimab for Atopic Dermatitis/Eczema (HYDRO Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight ≥40 kg and ≤150 kg

Participants must be 18 years of age (when signing informed consent form)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 up to week 32

Awards & highlights

HYDRO Trial Summary

This trial is to assess the safety and effectiveness of amlitelimab on vaccine responses in adults with moderate-to-severe atopic dermatitis.

Who is the study for?

Adults over 18 with moderate-to-severe atopic dermatitis (AD) for at least a year, who haven't responded well to topical treatments. They must have an AD area and severity index score of 12 or higher and AD covering at least 10% of their body. Not eligible if they've had certain vaccines recently, have skin conditions affecting assessments, immunosuppression issues, active infections, or a history of significant malignancies.Check my eligibility

What is being tested?

The trial is testing the effects of Amlitelimab on immune responses in adults with AD when given alongside Tdap (tetanus, diphtheria, pertussis) and PPSV (pneumococcal) vaccines compared to a placebo. The goal is to see if patients can still mount a strong defense against these diseases after receiving Amlitelimab.See study design

What are the potential side effects?

Potential side effects from Amlitelimab may include reactions at the injection site like redness or pain, increased risk of infection due to immune system changes, headaches, nausea and possibly other symptoms not yet known.

HYDRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My weight is between 40 kg and 150 kg.

Select...

I am at least 18 years old.

Select...

I have been diagnosed with atopic dermatitis for at least a year.

Select...

Topical treatments haven't worked for me in the past 6 months.

Select...

My skin condition affects 10% or more of my body.

HYDRO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 up to week 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 up to week 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 up to week 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Percentage of participants with a positive tetanus response at Week 16

Secondary outcome measures

Incidence of antidrug antibodies (ADAs) of amlitelimab

Percentage of participants discontinued from study treatment due to TEAEs

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

+4 more

HYDRO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AmlitelimabExperimental Treatment3 Interventions

Participants will receive amlitelimab and vaccines as per protocol.

Group II: PlaceboPlacebo Group3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tdap vaccine

2018

Completed Phase 2

~350

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,814 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,672 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the U.S. Food and Drug Administration given its stamp of approval to Amlitelimab?

"Our team rated the safety of Amlitelimab as a 2 out of 3. This is due to its Phase 2 classification, which confirms some evidence for safety but not efficacy."

Answered by AI

To what extent is the cohort in this research study being treated?

"Affirmative. Clinicaltrials.gov provides evidence that this research study, which was opened on 10/6/2023, is actively seeking participants. 166 volunteers are required from 5 different clinical sites."

Answered by AI

How many healthcare settings in Canada are engaged with this clinical experiment?

"Five distinct locations are hosting this clinical trial: Hamilton, London, Newmarket and two further unspecified sites. The corresponding investigational site numbers for each location are 1240020, 1240017, and 1240018 respectively."

Answered by AI

Is the opportunity for enrolment in this research still available?

"Affirmative. Per the information on clinicaltrials.gov, this scientific investigation is currently recruiting patients and was initially posted October 6th 2023; with its last update being October 27th 23rd. The trial has a target enrolment of 166 participants at 5 different facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015308.

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