REGN7041 for Uveitis
(TITAN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, REGN7041, for individuals with uveitis, which is inflammation inside the eye not caused by an infection. The main goal is to determine the drug's safety and tolerability. Researchers will also monitor for side effects, track how the drug moves through the body, and check for antibody production against it. This trial may suit those with ongoing uveitis affecting vision and not due to infection. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
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, participants are allowed to use eye drops to lower eye pressure, so some medications might be permitted. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that REGN7041 is likely to be safe for humans?
Research shows that REGN7041 is undergoing its first tests in humans, meaning no prior information exists about its safety in humans. In these early trials, researchers primarily focus on the body's response to the new drug. They identify any side effects and measure the drug's concentration in the blood and eye fluid. Additionally, they check for antibodies against the drug, which could reduce its effectiveness or cause side effects. Due to the trial's early stage, participants can expect close monitoring to assess REGN7041's safety and tolerability.12345
Why do researchers think this study treatment might be promising?
REGN7041 is unique because it represents a fresh approach to treating uveitis, a condition typically managed with corticosteroids or immunosuppressive agents. Unlike these standard treatments, which can have significant side effects and require long-term management, REGN7041 may offer a more targeted and potentially safer alternative. Researchers are particularly excited about its novel mechanism of action, which aims to address inflammation more directly and with fewer side effects. This could mean better disease control and improved quality of life for patients suffering from this challenging eye condition.
What evidence suggests that REGN7041 might be an effective treatment for uveitis?
Research shows that REGN7041 is under study as a treatment for uveitis, an inflammation inside the eye not caused by infection. The trial includes two treatment arms: Sequential Multiple Ascending Dose Cohorts and Sequential Single Ascending Dose Cohorts. This marks the first human testing of the drug, so information on its effectiveness is limited. However, the treatment targets specific processes that cause inflammation. Early studies on similar treatments have shown promise in reducing inflammation and the need for steroids, commonly used to manage uveitis. Although solid data on REGN7041 is not yet available, its method is based on successful results from other treatments for eye inflammation. This suggests potential effectiveness, but further research is needed to confirm this.13678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with active non-infectious uveitis, which is inflammation inside the eye without infection. Participants must have a specific level of visual acuity, meaning their sight isn't too good or too poor as measured by standard eye tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive REGN7041 to assess safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- REGN7041
Trial Overview
The trial is testing REGN7041, an experimental drug for reducing eye inflammation in uveitis patients. It's the first time this drug is being used in humans and will assess safety, tolerability, side effects, how much of the drug stays in blood and eye fluid over time, and if the body creates antibodies against it.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
A Study of REGN7041 for Active Noninfectious Uveitis in ...
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study. ... An ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/f5488b9e0049ad76/nct07218770-regeneron-regen7041-anti-cd3-uveitis-posterior-segmentA Study of REGN7041 for Active Noninfectious Uveitis in Adult ...
The study is focused on patients who have active inflammation inside of the eye without any signs of infection. The aim of the study is to see how safe and ...
3.
tipranks.com
tipranks.com/news/company-announcements/regeneron-initiates-promising-study-on-regn7041-for-eye-inflammationRegeneron Initiates Promising Study on REGN7041 for ...
This first-in-human trial will explore potential side effects, drug levels in blood and eye fluid, and the body's immune response to the drug.
The Conundrum of Clinical Trials for the Uveitides
A single, clinically relevant outcome, successful corticosteroid sparing, defined as inactive uveitis with a prednisone dose ≤7.5 mg/day.
The Latest Therapies and Trials in Uveitis
Early results (78 weeks follow-up) are showing sustained quiescence and reduced corticosteroid use in most patients (60% to 90%).15. The SYCAMORE trial ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-regn7041-for-active-noninfectious-uveitis-in-adult-participantsA Study of REGN7041 for Active Noninfectious Uveitis in Adult ...
The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans. The ...
7.
htsyndication.com
htsyndication.com/us-fed-news/article/clinical-trial%3A-a-study-of-regn7041-for-active-noninfectious-uveitis-in-adult-participants/555769091A Study of REGN7041 for Active Noninfectious Uveitis in ...
The study is focused on patients who have active inflammation inside of the eye without any signs of infection. The aim of the study is to see ...
JP Morgan Healthcare Conference
This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.