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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
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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atopic Dermatitis (AD) often involve immune modulation to reduce inflammation and alleviate symptoms. Monoclonal antibodies, such as Amlitelimab, target specific molecules like OX40-Ligand, which play a crucial role in the activation and survival of T-cells involved in the inflammatory response. By blocking these pathways, these treatments can significantly reduce the chronic inflammation seen in AD. Other treatments include Dupilumab, which targets IL-4 and IL-13 to reduce Th2-mediated inflammation, and JAK inhibitors, which interfere with the signaling pathways of various cytokines. These mechanisms are vital for AD patients as they address the underlying immune dysregulation, providing more effective and targeted relief compared to traditional therapies.

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Who is running the clinical trial?

SanofiLead Sponsor
2,173 Previous Clinical Trials
3,516,024 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
~290 spots leftby Oct 2027