← Back to Search

Monoclonal Antibodies

Amlitelimab for Eczema (RIVER-AD 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 18 years of age, inclusive, or older at the time of signing the informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dri17366 baseline to week 104
Awards & highlights

RIVER-AD Trial 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.

Who is the study for?
Adults with moderate to severe atopic dermatitis who participated in a previous study (KY1005-CT05) and either didn't improve enough, lost response over time, or experienced worsening after the study can join. They must be able to follow the trial's procedures and have no new medical conditions that would make them ineligible.Check my eligibility
What is being tested?
The safety and effectiveness of Amlitelimab are being tested in adults with moderate to severe atopic dermatitis over an extended period. Participants will receive regular treatments and assessments, sometimes through home visits if necessary.See study design
What are the potential side effects?
Potential side effects related to Amlitelimab may include reactions similar to those seen in other monoclonal antibody therapies such as hypersensitivity reactions or infusion-related responses. Specific side effects from prior studies aren't listed but could influence eligibility.

RIVER-AD 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.

RIVER-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dri17366 baseline to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and dri17366 baseline to week 104 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 event (TEAE)
Secondary outcome measures
Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
Absolute change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study
Anti-amlitelimab antibody titre in participants with positive response
+20 more

RIVER-AD Trial Design

1Treatment groups
Experimental Treatment
Group I: AmlitelimabExperimental Treatment4 Interventions
Subcutaneous injection Q4W

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,160 Previous Clinical Trials
3,514,012 Total Patients Enrolled

Media Library

Amlitelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05492578 — Phase 2
Amlitelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492578 — Phase 2
Atopic Dermatitis Clinical Trial 2023: Amlitelimab Highlights & Side Effects. Trial Name: NCT05492578 — Phase 2
Atopic Dermatitis Research Study Groups: Amlitelimab

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~300 spots leftby Oct 2027