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Tibulizumab

Phase 2

Hidradenitis Suppurativa (HS) | Monoclonal antibody | Dermatology |Zura Bio Limited|Trials Updated: Oct 19, 2026

Tibulizumab development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2025

Tibulizumab target and mechanism

Molecular targetIL17A, TNFSF13B
Target classInhibitor
ModalityMonoclonal antibody

Also known as ZB-106

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment327

FDA Designations

No designations recorded

Tibulizumab clinical trials

Tibulizumab · 2 trials · 3 indications

Phase 2 2
NCT06993610Tibulizumab Skin Healing and Inflammation Evaluation for Lasting DefenseHidradenitis Suppurativa (HS)
ACTIVE NOT_RECRUITING247 Analytics
NCT06843239Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)Systemic Sclerosis (SSc)
ACTIVE NOT_RECRUITING80 Analytics
PHASE2ACTIVE NOT_RECRUITING
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Hidradenitis Suppurativa (HS)Unlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Systemic Sclerosis (SSc)Unlock trial analytics

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

[Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
Week 24

The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)

[Period 2] Safety and tolerability of tibulizumab
Week 52

Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results

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
TibulizumabEXPERIMENTALSubcutaneous injection

Interventions

NameTypeDescription
Tibulizumab Dose ABIOLOGICALAnti BAFF/IL-17 antibody. ZB-106
Tibulizumab Dose BBIOLOGICALAnti BAFF/IL-17 antibody. ZB-106
PlaceboOTHERZB-106 Placebo
TibulizumabBIOLOGICALAnti BAFF/IL-17 antibody
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites61

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 StatesCanadaGermanyHungaryPolandSpainArgentinaChileMexicoRomaniaSerbiaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWOct 19, 2026NCT06993610Enrollment: 225 → 247
LOWOct 19, 2026NCT06993610Enrollment: 225 → 247
LOWOct 19, 2026NCT06993610Enrollment: 225 → 247

Frequently asked questions about Tibulizumab

What is Tibulizumab?

Tibulizumab is an investigational monoclonal antibody developed by Zura Bio Limited for immune-mediated skin and connective tissue diseases. It is being studied in Phase 2 clinical trials for hidradenitis suppurativa and systemic sclerosis. It is a dual-target inhibitor directed at IL17A and TNFSF13B.

What does Tibulizumab target?

Tibulizumab targets IL17A and TNFSF13B, and it acts as an inhibitor of both. By binding these two targets, the monoclonal antibody is designed to interfere with the inflammatory signaling pathways in which IL17A and TNFSF13B participate. This dual-target profile is the basis for its study in inflammatory skin and fibrotic conditions.

What is Tibulizumab used for?

Tibulizumab is being studied for hidradenitis suppurativa and systemic sclerosis, also called scleroderma. Both are the focus of its Phase 2 clinical development. It has not been established as a treatment outside of clinical research, and its use in these indications remains investigational.

Who makes Tibulizumab?

Tibulizumab is developed by Zura Bio Limited, which trades under the ticker ZURA. The company is running the Phase 2 program for the antibody in hidradenitis suppurativa and systemic sclerosis across multiple countries, including the United States, Canada, and several European and Latin American sites.

What phase is Tibulizumab in?

Tibulizumab is in Phase 2 clinical development. It is investigational and is being evaluated in two Phase 2 studies, one in hidradenitis suppurativa and one in systemic sclerosis. Both trials are currently listed as active but not recruiting.

What clinical trials is Tibulizumab in?

Tibulizumab is being studied in two Phase 2 trials. NCT06993610, the Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense study, enrolls 247 patients with hidradenitis suppurativa. NCT06843239, the TibuSURE study, enrolls 80 patients with systemic sclerosis and scleroderma. Both are randomized, double-blind, placebo-controlled trials in adults aged 18 and older.

Is Tibulizumab the same as Tibulizumab Dose A?

Yes, Tibulizumab Dose A is another name used for Tibulizumab. Readers searching under either name are referring to the same monoclonal antibody developed by Zura Bio Limited, a dual inhibitor of IL17A and TNFSF13B under Phase 2 study in hidradenitis suppurativa and systemic sclerosis.