Zura Bio has launched the randomised Phase II TibuSHIELD trial assessing tibulizumab in the adult population with moderate to severe hidradenitis suppurativa (HS).
Also referred to as acne inversa, HS is an inflammatory skin disease.
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The double-blind, placebo-controlled, global trial is set to enrol roughly 180 HS subjects across Canada, Europe, and the US.
It will monitor the therapy over a period of 28 weeks, which includes a 16-week primary efficacy evaluation, a safety follow-up period of 12-weeks, with an optional open-label extension (OLE).
Topline outcomes for the primary efficacy endpoint at the week 16 mark are anticipated in the third quarter of 2026.
TibuSHIELD claims to be the first study to assess the dual inhibition of the B-cell activating factor (BAFF) and interleukin-17A (IL-17A) pathways in this patient demographic.
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By GlobalDataSubjects will undergo 1:1:1 randomisation and will be given one of two different doses of the therapy or a placebo.
The primary goal of the study is the percentage change from baseline in total abscess and nodule (AN) count at week 16.
Secondary endpoints will assess the proportion of subjects achieving significant reductions in AN count without a rise in abscesses or draining fistulas at week 16.
Key safety evaluations will include tolerability and monitoring for adverse events.
The current trial comes after the commencement of the TibuSURE trial in December last year, which also evaluated tibulizumab but in adults with systemic sclerosis.
Zura Bio Development head and chief medical officer Kiran Nistala said: “The initiation of TibuSHIELD marks a key milestone in our mission to advance potentially differentiated therapies for patients with severe inflammatory diseases.
“We remain committed to advancing clinical development with investigators, clinical sites, and the HS community.”
According to the company, tibulizumab is a humanised dual-antagonist antibody, designed by fusing Taltz (ixekizumab) and tabalumab for attaching and neutralising IL-17A and BAFF.
