Tibulizumab for Hidradenitis Suppurativa

(TibuSHIELD Trial)

Recruiting at 49 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zura Bio Inc

Disqualifiers: Tuberculosis, Immune deficiency, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

180 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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

Total AN (abscesses and inflammatory nodules) count ≥5

I am between 18 and 70 years old.

I have skin lesions in 2 or more areas, with at least one area being moderate to severe.

Exclusion Criteria

Known to have immune deficiency or is immunocompromised

Draining tunnel count >20

I have an active yeast infection in my blood.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tibulizumab or placebo over 16 weeks in a double-blind, placebo-controlled setting

16 weeks

Regular visits for assessments and monitoring

Open-label Extension

All participants receive tibulizumab for an additional 16 weeks

16 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tibulizumab

Trial Overview

The trial is testing two different doses of Tibulizumab against a placebo to see how well they help heal skin and reduce inflammation in hidradenitis suppurativa over 16 weeks. Afterward, all participants will receive Tibulizumab for another 16 weeks.

How Is the Trial Designed?

Group I: Tibulizumab Dose B Experimental Treatment 1 Intervention

Subcutaneous injection

Group II: Tibulizumab Dose A Experimental Treatment 1 Intervention

Subcutaneous injection

Group III: Placebo Placebo Group 1 Intervention

Subcutaneous injection

Who Is Running the Clinical Trial?

Zura Bio Inc

Lead Sponsor

Trials

1

Recruited

80+

Citations

1.

investors.zurabio.com

investors.zurabio.com/news-releases/news-release-details/zura-bio-launches-global-phase-2-tibushield-study-evaluate

Zura Bio Launches Global Phase 2 TibuSHIELD Study to ...

The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with ...

2.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/zura-bio-tibulizumab/

Zura Bio begins trial of tibulizumab for hidradenitis ...

Topline outcomes for the primary efficacy endpoint at the week 16 mark are anticipated in the third quarter of 2026. TibuSHIELD claims to be ...

3.

sec.gov

sec.gov/Archives/edgar/data/1855644/000110465925050715/tm2515452d1_ex99-1.htm

99.1

The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with ...

4.

synapse.patsnap.com

synapse.patsnap.com/article/zura-bio-starts-global-phase-2-study-on-tibulizumab-for-hidradenitis-suppurativa

Zura Bio Starts Global Phase 2 Study on Tibulizumab for ...

This trial aims to examine the effects of tibulizumab in adult patients suffering from moderate to severe hidradenitis suppurativa (HS), a ...

5.

biospace.com

biospace.com/zura-bio-presents-data-for-the-tibulizumab-zb-106-program-at-eular-2024

Zura Bio Presents Data for the Tibulizumab (ZB-106) ...

Tibulizumab is expected to enter Phase 2 clinical development for the treatment of systemic sclerosis in Q4-2024 and hidradenitis suppurativa in ...

6.

finance.yahoo.com

finance.yahoo.com/news/zura-bio-commences-phase-ii-105134369.html

Zura Bio commences Phase II trial of tibulizumab for ...

Zura Bio has launched the randomised Phase II TibuSHIELD trial assessing tibulizumab in the adult population with moderate to severe ...

7.

synapse.patsnap.com

synapse.patsnap.com/drug/7ba94c9d3b954fcd98c3f76ff4309fdc

Tibulizumab - Drug Targets, Indications, Patents

... Safety, and Tolerability of Tibulizumab in Adults With Hidradenitis Suppurativa ... SUPPURATIVA Hidradenitis suppurativa (HS), also known as acne inversa ...