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A phase 2, multi-center study consisting of a randomized, placebo-controlled period, followed by an open-label extension period to assess the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519736-17-00
Acronym
ZB-106-HS-202
Enrollment
90
Registered
2025-09-10
Start date
2025-10-03
Completion date
Unknown
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Brief summary

Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16

Detailed description

Achieving HiSCR50 at Week 16; Achieving HiSCR75 at Week 16, Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16; Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16; Absolute change from baseline in skin pain numerical rating scale (NRS) at Week 16, Incidence and severity of treatment emergent adverse events (TEAEs); Absolute change from baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results

Interventions

Sponsors

Zura Bio Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16

Secondary

MeasureTime frame
Achieving HiSCR50 at Week 16; Achieving HiSCR75 at Week 16, Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16; Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16; Absolute change from baseline in skin pain numerical rating scale (NRS) at Week 16, Incidence and severity of treatment emergent adverse events (TEAEs); Absolute change from baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results

Countries

Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026