Tibulizumab for Hidradenitis Suppurativa
(TibuSHIELD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests tibulizumab, a new treatment for hidradenitis suppurativa, a skin condition that causes painful lumps and sores. The study aims to evaluate tibulizumab's effectiveness in reducing symptoms over 16 weeks compared to a placebo (an inactive substance). After this period, all participants receive tibulizumab for an additional 16 weeks. Individuals who have had hidradenitis suppurativa for at least six months, with sores in two or more areas, may be suitable candidates for this trial. As a Phase 2 trial, this research measures tibulizumab's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that tibulizumab is likely to be safe for humans?
Research shows that tibulizumab is under investigation for safety and tolerance in people with hidradenitis suppurativa. In earlier studies with adults, tibulizumab was generally well-tolerated. Although specific details about side effects from these studies aren't provided, the current phase of research focuses on understanding its safety and side effects. This indicates that the treatment has shown some promise in earlier research. Participants usually report mild to moderate side effects, but these are still under study. As with any treatment, discussing potential risks and benefits with a healthcare provider is important.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about Tibulizumab for treating Hidradenitis Suppurativa because it offers a potentially new approach compared to current treatments like antibiotics, retinoids, or biologics such as adalimumab. Unlike these standard options, Tibulizumab is designed to be administered as a subcutaneous injection with two different dosing strategies, potentially providing a more tailored treatment experience. Moreover, if Tibulizumab targets specific pathways involved in the inflammatory process of the condition differently, it could offer relief for patients who don't respond well to existing therapies. This could make a significant difference in managing a condition known for its painful and chronic nature.
What evidence suggests that tibulizumab might be an effective treatment for hidradenitis suppurativa?
Research has shown that tibulizumab might help treat hidradenitis suppurativa (HS), a painful skin condition. This trial will evaluate different doses of tibulizumab, with participants receiving either Tibulizumab Dose A, Tibulizumab Dose B, or a placebo. Researchers are examining this treatment for its potential to reduce flare-ups and symptoms. Although specific data for HS is limited, tibulizumab is also under study for other conditions like systemic sclerosis, suggesting it might offer broader benefits. Tibulizumab targets certain immune responses, which could explain its potential effectiveness for HS. Early results appear promising, but further research is needed to confirm its effectiveness.12367
Are You a Good Fit for This Trial?
Adults with hidradenitis suppurativa, a chronic skin condition, can join this trial. Participants must have a history of the disease and meet specific health criteria not detailed here. Those with certain medical conditions or treatments that could interfere with the study are excluded.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 over 16 weeks in a double-blind, placebo-controlled setting
Open-label Extension
All participants receive tibulizumab for an additional 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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