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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ dri17366 baseline to week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dri17366 baseline to week 104
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 moreTrial 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
3,516,040 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no cancer history, except for non-melanoma skin cancer cured over 5 years ago.I am 18 years old or older.I have a skin condition that could interfere with skin tests.I have a history of serious infections or a weak immune system.I have fully recovered from side effects of previous Alzheimer's drugs for more than 2 weeks.I do not have severe illnesses like heart failure or kidney disease that would stop me from joining the study.I have had a solid organ or stem cell transplant.I do not have active or latent TB, nor have I been in close contact with TB patients recently.
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Amlitelimab
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