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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.
Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
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 belowSelect...
I am 18 years old or older.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16 to eos (week 176)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 to eos (week 176)
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 moreATLANTIS 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
2,164 Previous Clinical Trials
3,514,079 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,018,937 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious immune system problems or frequent, long-lasting infections.You have tested positive for HIV, hepatitis B, or hepatitis C.I do not have active or latent TB, nor have I been in close contact with TB patients recently.You have severe itching, with a weekly average rating of 4 or higher on a scale from 0 to 10.I have not had any serious infections or COVID-19 that needed treatment in the last 4 weeks.I am not allergic to any medication ingredients.I have no cancer history, except for non-melanoma skin cancer cured over 5 years ago.I have had a solid organ or stem cell transplant.I haven't had live vaccines in the last 12 weeks and have completed all required vaccinations, including for COVID-19, at least 14 days ago.I am 18 years old or older.Topical treatments haven't worked for me in the last 6 months.Your eczema is very severe, with an Eczema Area Severity Index (EASI) score of 16 or higher.I have received specific treatments within the required time before my first visit.I have been diagnosed with atopic dermatitis for over a year.I don't have any upcoming surgeries that would stop me from taking my trial medication regularly.10% or more of my skin is affected by atopic dermatitis.You have a skin condition that may make it difficult to do the required assessments.At the start of the study, a doctor has rated your atopic dermatitis as moderate or severe using a specific scale.
Research Study Groups:
This trial has the following groups:- Group 1: Amlitelimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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