Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense (TibuSHIELD)

Zura Bio Inc

Status and phase: Enrolling; Phase 2

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Biological: Tibulizumab Dose B; Other: Placebo; Biological: Tibulizumab Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06993610

2024-519736-17-00 (EU Trial (CTIS) Number)

ZB-106-HS-202

Details and patient eligibility

About

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)

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 to 70 years of age
• ≥6-month history of Hidradenitis suppurativa (HS)
• Total AN (abscesse and inflammatory nodule) count ≥5
• HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III

Exclusion criteria

• Draining tunnel count >20
• Presence of another inflammatory condition or a skin condition that may interfere with study assessments
• Known to have immune deficiency or is immunocompromised
• Evidence or suspicion of active or latent tuberculosis
• History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks
• Has active systemic candidiasis
• Unable to tolerate subcutaneous drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Tibulizumab Dose A

Experimental group

Description:

Subcutaneous injection

Treatment:

Biological: Tibulizumab Dose A

Tibulizumab Dose B

Experimental group

Description:

Subcutaneous injection

Treatment:

Biological: Tibulizumab Dose B

Placebo

Placebo Comparator group

Description:

Subcutaneous injection

Treatment:

Other: Placebo