Tibulizumab for Hidradenitis Suppurativa

(TibuSHIELD Trial)

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

Trial Summary

What is the purpose of this trial?

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+