Tibulizumab for Scleroderma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests tibulizumab, a new treatment for systemic sclerosis, a condition that causes hardening and tightening of the skin and connective tissues. The researchers aim to evaluate tibulizumab's effectiveness over a 24-week period compared to a placebo (a non-active treatment), followed by an open-label period where all participants receive tibulizumab for further evaluation. The trial seeks individuals who have had systemic sclerosis for 7 years or less and exhibit symptoms like skin thickening near the elbows or knees. Participants will receive the treatment through a subcutaneous injection (an injection under the skin). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is there any evidence suggesting that tibulizumab is likely to be safe for humans?
Research is examining how tibulizumab affects systemic sclerosis, a condition that thickens the skin and lungs. The studies focus on the safety and tolerability of tibulizumab, assessing whether people can take the drug without serious side effects. As this trial is in an early phase, tibulizumab has shown some safety in humans but requires further testing. In later phases, more safety information would be available. The research continues to ensure its safety for wider use.12345
Why do researchers think this study treatment might be promising for scleroderma?
Unlike the standard treatments for scleroderma, which often include immunosuppressants and medications like methotrexate and mycophenolate mofetil, Tibulizumab is unique because it offers a new approach by targeting specific pathways involved in the disease. Researchers are excited about Tibulizumab because it is administered via a subcutaneous injection, making it potentially more convenient compared to some existing treatment options that require oral or intravenous administration. Additionally, Tibulizumab may have a novel mechanism of action that could provide benefits for patients who do not respond well to current therapies, potentially offering a more effective way to manage the symptoms of scleroderma.
What evidence suggests that tibulizumab might be an effective treatment for scleroderma?
Research has shown that tibulizumab, which participants in this trial may receive, might help treat systemic sclerosis, a disease that causes the skin and other organs to harden. This treatment targets proteins that cause inflammation, such as IL-17A and BAFF, potentially reducing disease symptoms. Early findings suggest that tibulizumab is generally safe and causes few harmful effects. While the initial results are promising, further studies are needed to confirm its effectiveness.12678
Who Is on the Research Team?
Study Director
Principal Investigator
Zura Bio Inc
Are You a Good Fit for This Trial?
This trial is for adults with systemic sclerosis, a condition where skin and connective tissues harden. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details aren't provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tibulizumab or placebo for 24 weeks in a double-blind, placebo-controlled manner
Open-label extension
All participants receive tibulizumab and are evaluated for safety and efficacy over an additional 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after the open-label extension
What Are the Treatments Tested in This Trial?
Interventions
- Tibulizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zura Bio Inc
Lead Sponsor