Amlitelimab for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called amlitelimab to assess its safety and tolerability in healthy adults. It will also evaluate the effectiveness of different devices and doses in delivering the medication. Participants will receive a single dose injected under the skin, using either a prefilled pen or syringe, at varying doses. This trial targets healthy adults without major ongoing health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults, it's possible that taking certain medications might affect your eligibility. It's best to discuss your specific situation with the trial organizers.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that amlitelimab is generally safe and well-tolerated. In earlier studies, participants experienced mild injection site reactions slightly more often with amlitelimab than with a placebo. However, these reactions were mild, and participants recovered quickly. The overall safety profile of amlitelimab is reassuring, with no allergic reactions reported. Although one death occurred during a study extension period, it happened months after a low dose and was not directly related to the treatment. This treatment remains in the early testing stages, so safety information is limited, but it appears promising so far.12345
Why are researchers excited about this trial's treatments?
Amlitelimab is unique because it offers a fresh approach to treating autoimmune conditions by targeting the OX40L pathway, which plays a key role in immune system regulation. Unlike traditional treatments that often suppress the entire immune system, amlitelimab specifically modulates immune responses, potentially reducing side effects. Researchers are excited about its subcutaneous delivery via prefilled pens and syringes, which could enhance convenience and improve patient compliance compared to more invasive options.
What evidence suggests that this trial's treatments could be effective?
Research has shown that amlitelimab can help treat atopic dermatitis (AD), a skin condition. In several studies, amlitelimab reduced symptoms and improved skin health in adults with moderate-to-severe AD. Participants experienced noticeable improvements, and the treatment was generally well tolerated, with most people not experiencing serious side effects. These findings suggest that amlitelimab could be an effective treatment option for skin conditions like AD.26789
Are You a Good Fit for This Trial?
This trial is for healthy men and women aged 18-55 who have passed a thorough medical exam. Participants must weigh between 50-100 kg if male, or 40-90 kg if female, with a body mass index of 18-30 kg/m2.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of subcutaneous amlitelimab delivered by different devices
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amlitelimab
Trial Overview
The study is testing the bioequivalence of the drug Amlitelimab when delivered by two different devices at varying doses. It's an open-label, randomized Phase 1 trial with four groups receiving single doses to compare safety and tolerability.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP.
Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP).
Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS.
Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Citations
Phase 2b randomized clinical trial of amlitelimab, an anti- ...
Conclusions: Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52. Sustained ...
Phase 2b randomized clinical trial of amlitelimab, an anti ...
Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52.
Press Release: Sanofi's amlitelimab met all primary and ...
Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic ...
53907 Amlitelimab improves extent and severity of disease ...
Conclusion: Amlitelimab improved metrics of disease extent and severity in adults with moderate-to-severe AD in the first 24 weeks of this Phase 2b trial, with ...
Safety and efficacy of amlitelimab, a fully human nondepleting ...
This phase IIa double-blind placebo-controlled study assessed the safety and efficacy of amlitelimab over 16 weeks in adults with atopic dermatitis (AD). A.
NCT07146750 | A Bioequivalence Study of Amlitelimab ...
Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). Intervention/ ...
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clinicaltrials.eu
clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-amlitelimab-for-patients-aged-12-and-older-with-moderate-to-severe-atopic-dermatitis/Study on the Effectiveness and Safety of Amlitelimab for ...
This study tests the effectiveness and safety of the monoclonal antibody amlitelimab, administered via subcutaneous injection, ...
Safety and efficacy of amlitelimab, a fully human ...
Amlitelimab was generally well tolerated with an unremarkable safety profile; no hypersensitivity events were reported. For the primary ...
Safety and efficacy of amlitelimab, a fully human ...
In the study extension period, one death was reported in a 44-year-old man 3 months after the last administration of a low dose of amlitelimab.
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