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Tibulizumab Dose A

Phase 2

Hidradenitis Suppurativa (HS) | Monoclonal antibody | Dermatology |Zura Bio Limited|Last Updated: Feb 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment225
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06993610Tibulizumab Skin Healing and Inflammation Evaluation for Lasting DefensePHASE2 RECRUITING 225May 16, 2025Apr 1, 2027Feb 12, 202656 United States, Canada +4
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Study Endpoints
Primary Endpoints
[Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
Week 16

AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas

Secondary Endpoints
[Period 1] Achieving HiSCR50 at Week 16
Week 16
[Period 1] Achieving HiSCR75 at Week 16
Week 16
[Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tibulizumab Dose AEXPERIMENTALSubcutaneous injection
Tibulizumab Dose BEXPERIMENTALSubcutaneous injection
PlaceboPLACEBO_COMPARATORSubcutaneous injection
Interventions
NameTypeDescription
Tibulizumab Dose ABIOLOGICALAnti BAFF/IL-17 antibody. ZB-106
Tibulizumab Dose BBIOLOGICALAnti BAFF/IL-17 antibody. ZB-106
PlaceboOTHERZB-106 Placebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: * Male or female, 18 to 70 years of age * ≥6-month history of Hidradenitis suppurativa (HS) * Total AN (abscess 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...

Countries:United StatesCanadaGermanyHungaryPolandSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06993610primaryCompletionDate: changed
LOWMay 24, 2026NCT06993610studyFirstPostDate: changed