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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.
Must not have
History of solid organ or stem cell transplant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 to eos (week 176)
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a solid organ or stem cell transplant.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs)
Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Secondary study objectives
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
+29 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,209 Previous Clinical Trials
4,038,865 Total Patients Enrolled
43 Trials studying Eczema
16,023 Patients Enrolled for Eczema
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,020,853 Total Patients Enrolled
11 Trials studying Eczema
1,325 Patients Enrolled for Eczema
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.
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