Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

February 10, 2026 updated by: Zura Bio Inc

A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426
        • Recruiting
        • Consultorios Médicos Dr. Doreski
        • Contact:
      • Buenos Aires, Argentina, C1061
        • Recruiting
        • Centro de Investigación y Prevención Cardiovascular-Arenales
        • Contact:
      • Buenos Aires, Argentina, C1405BFN
        • Recruiting
        • Instituto de Investigación Clínica TyT
        • Contact:
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)
        • Contact:
      • Buenos Aires, Argentina, C1015
        • Recruiting
        • Organizacion Medica de Investigacion
        • Contact:
      • Buenos Aires, Argentina, C1221AFC
        • Recruiting
        • Hospital General de Agudos Dr. José María Ramos Mejia
        • Contact:
      • Córdoba, Argentina, X5000KEH
        • Recruiting
        • Consultora Integral de Salud Centro Médico Privado
        • Contact:
      • Quilmes, Argentina, B1878DVB
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • AES - AS - Clinica Mayo de Urgencias
        • Contact:
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1023
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Médicas Tucuman
        • Contact:
  • Chile
      • Santiago, Chile, 7500000
        • Recruiting
        • CTR Estudios Clinicos
        • Contact:
      • Santiago, Chile, 8320000
      • Temuco, Chile, 4810345
        • Recruiting
        • Centro de especialidades médicas Vanguardia
        • Contact:
      • Valdivia, Chile, 683
        • Recruiting
        • Clinical Research Chile SpA
        • Contact:
      • Victoria, Chile, 4720000
        • Recruiting
        • Centro de Estudios Clinicos Victoria Limitada (Cevic)
        • Contact:
      • Vitacura, Chile, 7640881
        • Recruiting
        • Dermacross Clinica Dermatologica
        • Contact:
  • Hungary
      • Pécs, Hungary, 7622
        • Recruiting
        • Pécsi Tudomanyegyetem - Vasvari Pal u.
        • Contact:
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Recruiting
        • Mediadvance Clinical
        • Contact:
      • Guadalajara, Mexico, 44670
        • Recruiting
        • PanAmerican Clinical Research
        • Contact:
      • Miguel Hidalgo, Mexico, 11850
        • Recruiting
        • Centro de Investigación y Tratamiento Reumatológico S.C
        • Contact:
      • Mérida, Mexico, 97070
        • Recruiting
        • Medical Care and Research S.A. de C.V.
        • Contact:
      • Oaxaca City, Mexico, 68000
        • Recruiting
        • Oaxaca Site Management Organization - Clinic - OSMO - PPDS
        • Contact:
  • Poland
      • Chorzów, Poland, 41-500
      • Krakow, Poland, 30-363
        • Recruiting
        • Centrum Medyczne Plejady
        • Contact:
      • Krakow, Poland, 30-149
        • Recruiting
        • Malopolskie Centrum Kliniczne
        • Contact:
      • Krakow, Poland, 30-002
        • Recruiting
        • Malopolskie Badania Kliniczne Sp. z o.o.
        • Contact:
      • Poznan, Poland, 60-324
        • Recruiting
        • Twoja Przychodnia PCM - ul.
        • Contact:
      • Warsaw, Poland, 02-665
        • Recruiting
        • Klinika Reuma Park sp . zoo Sp.k.
        • Contact:
      • Warsaw, Poland, B1000-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa
        • Contact:
  • Romania
      • Bucharest, Romania, 11172
        • Recruiting
        • Sf.Maria Clinical Hospital
        • Contact:
      • Bucharest, Romania, 030463
        • Recruiting
        • Center for Clinical and Basic Research (CCBR)
        • Contact:
      • Bucharest, Romania, 41303
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Military Medical Academy
        • Contact:
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Rheumatology - PPDS
        • Contact:
  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
      • Barcelona, Spain, 08208
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Contact:
      • Seville, Spain, 41010
        • Recruiting
        • Hospital Quironsalud Infanta Luisa
        • Contact:
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary
        • Contact:
      • Bath, United Kingdom, BA1 3NG
        • Recruiting
        • Royal National Hospital for Rheumatic Diseases
        • Contact:
      • Dundee, United Kingdom, DD2 1SG
      • Leeds, United Kingdom, LS7 4SA
        • Recruiting
        • Chapel Allerton Hospital
        • Contact:
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • Aintree University Hospital
        • Contact:
      • London, United Kingdom, NW3 2QG
      • Stoke-on-Trent, United Kingdom, ST6 7AG
        • Recruiting
        • Haywood Community Hospital
        • Contact:
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UCSD Altman Clinical and Translational Research Institute Center for Clinical Research
        • Contact:
    • Florida
      • Plantation, Florida, United States, 33324
        • Recruiting
        • IRIS Research and Development LLC
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital
        • Contact:
    • Texas
      • Arlington, Texas, United States, 76012
        • Recruiting
        • Rheumatology Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female, 18 to 75 years of age
  • Body mass index between 18.0 and 38.0 kg/m²
  • Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
  • Has diffuse cutaneous SSc, defined as mRSS >0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
  • Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years
  • mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive
  • FVC >50% predicted
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)

Exclusion Criteria:

  • Has any of the following complications:

    • Left ventricular failure
    • Pulmonary arterial hypertension
    • Renal crisis within previous 6 months
    • Gastrointestinal dysmotility within previous 3 months
    • Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months
  • Current rheumatic disease other than SSc that could interfere with assessment of SSc
  • Lung disease requiring continuous oxygen therapy
  • Evidence or suspicion of active or latent tuberculosis
  • Active Crohn's Disease or ulcerative colitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subcutaneous injection
Biological: Tibulizumab
Anti BAFF/IL-17 antibody
Other Names:
  • ZB-106
Other: Placebo
Placebo (inactive)
Other Names:
  • ZB-106 placebo
Experimental: Tibulizumab
Subcutaneous injection
Biological: Tibulizumab
Anti BAFF/IL-17 antibody
Other Names:
  • ZB-106

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
Time Frame: 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)
Week 24
[Period 2] Safety and tolerability of tibulizumab
Time Frame: 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
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[Period 1] Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: Week 24
HAQ-DI evaluates patients' self-assessed degree of disability across eight categories, with scores ranging from 0 to 3, where 3 indicates the worst degree of disability
Week 24
[Period 1] Safety and tolerability of tibulizumab
Time Frame: Week 24
Assessed by the incidence of all TEAEs, as well as changes from baseline in vital signs, ECG parameters, and laboratory results
Week 24
[Period 2] Change from baseline in mRSS
Time Frame: Week 52
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)
Week 52
[Period 1] Change from baseline in quantitative interstitial lung disease (QILD) obtained with high-resolution quantitative tomography (HRCT) in the whole lung in participants with SSc-interstitial lung disease (ILD)
Time Frame: Week 24
HRCT measures the extent of interstitial lung disease by quantifying the amount of lung fibrosis, ground-glass opacity, and honeycomb lung, which are used to calculate the QILD score (scores can range from 0 to 100%, with higher scores indicating greater disease extent)
Week 24
[Period 2] Change from baseline in QILD obtained with HRCT in the whole lung in participants with SSc-ILD
Time Frame: Week 52
HRCT measures the extent of interstitial lung disease by quantifying the amount of lung fibrosis, ground-glass opacity, and honeycomb lung, which are used to calculate the QILD score (scores can range from 0 to 100%, with higher scores indicating greater disease extent)
Week 52
[Period 1] Change from baseline in forced vital capacity (FVC) in participants with SSc-ILD
Time Frame: Week 24
FVC is the amount of air that can be forcibly exhaled after the deepest possible breath
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zura Bio Inc

Investigators

  • Study Director: Study Director, Zura Bio Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZB-106-SS-201
  • 2024-519335-42-01 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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