All > Seborrheic Dermatitis > Atopic Dermatitis

Amlitelimab for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Investigational Site Number :1241106, Markham, CanadaAtopic DermatitisAmlitelimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trialwill study the safety and effectiveness of a drug in adults with moderate to severe AD, requiring visits every 4 weeks and if needed, home visits for administration of drug and assessment of vital signs.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 23 Secondary · Reporting Duration: DRI17366 Baseline to Week 104

Baseline to Week 104
Absolute change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
Dermatitis, Atopic
Change from LTE baseline to prespecified time points through the end of the study: dermatology life quality index (DLQI) in all participants entering the study
Eczema
Percent change from LTE baseline in EASI score at pre-specified timepoints in all participants entering the study
Proportion of participants with EASI50/ EASI75/EASI90/EASI100 at pre-specified timepoints in all participants entering the study
Proportion of participants with IGA score 0/1 at each visit in all participants entering the study
Proportion of participants with a response of investigator global assessment (IGA) 0 or 1and a reduction from baseline of >= 2 points at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Proportion of participants with low disease activity state (e.g., IGA <= 2) at each visit in all participants entering the study
Serum amlitelimab concentration assessed at prespecified time points through the end of the study
Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTE entry in all participants entering the study
Time to first remission after LTE enrolment (achieving IGA 0/1) in those participants who had not achieved IGA 0/1 by the time of LTE entry in all participants entering the study
Baseline to Week 120
Anti-amlitelimab antibody titre in participants with positive response
Pharmaceutical Preparations
Number of participants with positive anti-drug antibody response
Therapeutic procedure
Percentage of participants who experienced treatment-emergent adverse event (TEAE) from baseline during the study
Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) from baseline during study
Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study
Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study
Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study
Week 104
Absolute change from KY1005-CT05 (DRI17366) baseline in Eczema Area and Skin Severity Index (EASI) score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Percent change from KY1005-CT05 (DRI17366) baseline in EASI score at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24
Proportion of participants with EASI75/EASI90/EASI100 from KY1005-CT05 (DRI17366) baseline at each visit in participants entering the study from KY1005-CT05 (DRI17366) Week 24

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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2
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Trial Design

1 Treatment Group

Amlitelimab
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: Amlitelimab · No Placebo Group · Phase 2

Amlitelimab
Drug
Experimental Group · 1 Intervention: Amlitelimab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: dri17366 baseline to week 104

Who is running the clinical trial?

SanofiLead Sponsor
2,051 Previous Clinical Trials
2,960,318 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You previously participated in a study called KY1005-CT05 and were re-randomized for further treatment. If you complete the study and experience worsening of your AD during safety follow-up or afterwards, you will not be eligible for this trial.
You must be at least 18 years old to sign up for the study.
If you were in a previous study for eczema treatment and did not show significant improvement after 24 weeks based on a skin severity index and your doctor's assessment, you are excluded from this study.
You participated in the parent study and experienced a loss of clinical response during the second part of the study, between Week 28 to Week 52. This means you did not achieve a certain level of improvement in your skin condition.
You must understand the study and agree to follow the rules.
References

Frequently Asked Questions

Are members of the public currently able to access this clinical experiment?

"Affirmative, the information hosted on clinicaltrials.gov displays that this study is presently enrolling patients. The medical trial was initially posted on August 22nd 2022 and has been recently revised as of November 29th 2022. 300 people are currently being sought from 3 different sites for participation in the research." - Anonymous Online Contributor

Unverified Answer

How many enrollees are being admitted to this research endeavor?

"Affirmative, clinicaltrials.gov states that this research project is currently engaging in recruitment efforts. It was posted on 8th August 2022 and modified most recently on 29th November 2022. It aims to source 300 participants from 3 different sites." - Anonymous Online Contributor

Unverified Answer

Has Amlitelimab been given regulatory authorization by the FDA?

"Our assessment at Power of Amlitelimab's safety is a 2 due to the lack of efficacy trials and only some data on its security." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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