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Monoclonal Antibodies

Amlitelimab for Eczema (ATLANTIS 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
Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
Participant must have documented history within 6 months prior to screening visit, of either inadequate response or inadvisability of topical treatments.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 to eos (week 176)
Awards & highlights

ATLANTIS Trial Summary

This trial is studying the safety and effectiveness of a new treatment for moderate to severe eczema over 3 years. Participants will have 26 visits over 180 weeks.

Who is the study for?
Adults with moderate to severe atopic dermatitis (AD) who haven't responded well to topical treatments can join this study. They must have had AD for over a year, an Eczema Area Severity Index score of 16+, and cover at least 10% of their body. Pregnant or breastfeeding women are excluded, as are those with certain infections like TB, HIV, hepatitis B/C, or recent vaccinations.Check my eligibility
What is being tested?
The trial is testing Amlitelimab's long-term safety and effectiveness in adults with moderate to severe AD. Participants will be observed for approximately three years during which they'll receive the drug and attend 26 scheduled visits including follow-ups after treatment ends.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions due to Amlitelimab throughout the study period. This includes regular check-ups and assessments.

ATLANTIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
Topical treatments haven't worked for me in the last 6 months.
Select...
I have been diagnosed with atopic dermatitis for over a year.
Select...
10% or more of my skin is affected by atopic dermatitis.

ATLANTIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 to eos (week 176)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 to eos (week 176) 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 who experienced Treatment-Emergent Adverse Events (TEAEs)
Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Secondary outcome measures
Change in Atopic Dermatitis Control Test (ADCT) from baseline
Change in Children's Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old
Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age ≥16 years old
+32 more

ATLANTIS Trial Design

1Treatment groups
Experimental Treatment
Group I: AmlitelimabExperimental Treatment1 Intervention
Subcutaneous injection as per protocol

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,511,579 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,398 Total Patients Enrolled

Media Library

Amlitelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05769777 — Phase 2
Atopic Dermatitis Research Study Groups: Amlitelimab
Atopic Dermatitis Clinical Trial 2023: Amlitelimab Highlights & Side Effects. Trial Name: NCT05769777 — Phase 2
Amlitelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05769777 — Phase 2

Frequently Asked Questions

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

What potential risks have been associated with Amlitelimab treatment?

"Due to the lack of clinical evidence on its efficacy, Amlitelimab is given a score of 2 in terms of safety. Nevertheless, there are some data that support it being safe for human usage."

Answered by AI

How many people have consented to participate in this research endeavor?

"In order to adequately conduct this trial, an aggregate of 571 eligible participants are necessary. Potential patients may enrol in the research at either Investigational Site Number :1240011 in Oakville, Ontario or investigational Site Number: 1240004 located within Peterborough, Hokkaido."

Answered by AI

How many venues are being utilized for this research project?

"This research is currently enrolling participants from 10 different sites. These include Investigational Site Number :1240011 in Oakville, Ontario, Investigational Site Number :1240004 in Peterborough, Hokkaido and Investigational Site Number :3923114 in Obihiro-Shi, Kanagawa as well as 7 other locations."

Answered by AI

Are new participants currently being accepted for registration in this trial?

"Affirmative. Clinicaltrials.gov data points to the fact that, since its inception on April 3rd 2023, this experiment has been actively recruiting 571 subjects across 7 medical centres."

Answered by AI
~601 spots leftby Oct 2028