Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

NCT06843239 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: ZB-106-SS-2012024-519335-42-01
• Study Type: interventional
• Target: 80
• Locations: 10 countries
• Sites: 60

Brief Summary

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)

Conditions

Scleroderma; Systemic Sclerosis (SSc)

Keywords

Scleroderma; Systemic Sclerosis (SSc); Tibulizumab; Cutaneous; Interstitial lung disease (ILD); Autoimmune diseases; Immune system diseases; Systemic Sclerosis interstitial lung disease (SSC-ILD); Skin Diseases

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (6)

• [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)

  Week 24

• [Period 1] Change from baseline in forced vital capacity (FVC) in participants with SSc-ILD

  Week 24

• [Period 1] Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)

  Week 24

• [Period 1] Safety and tolerability of tibulizumab

  Week 24

• [Period 2] Change from baseline in mRSS

  Week 52

Study Arms (2)

Tibulizumab

EXPERIMENTAL

Subcutaneous injection

Biological: Tibulizumab

Placebo

PLACEBO COMPARATOR

Subcutaneous injection

Biological: Tibulizumab; Other: Placebo

Interventions

Tibulizumab BIOLOGICAL

Anti BAFF/IL-17 antibody

Also known as: ZB-106

Placebo; Tibulizumab

Placebo OTHER

Placebo (inactive)

Also known as: ZB-106 placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zura Bio Inc: lead

Study Sites (60)

UCSD Altman Clinical and Translational Research Institute Center for Clinical Research

La Jolla, California, 92037, United States

Location

UCLA Department of Medicine

Los Angeles, California, 90024, United States

Location

IRIS Research and Development LLC

Plantation, Florida, 33324, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Rheumatology Associates

Arlington, Texas, 76012, United States

Location

STAT Research S.A.

Buenos Aires, Buenos Aires, C1023, Argentina

Location

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Organización Médica de Investigación

Buenos Aires, C1015, Argentina

Location

Centro de Investigación y Prevención Cardiovascular-Arenales

Buenos Aires, C1061, Argentina

Location

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, C1221AFC, Argentina

Location

Instituto de Investigación Clínica TyT

Buenos Aires, C1405BFN, Argentina

Location

Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)

Buenos Aires, C1426ABP, Argentina

Location

Consultorios Médicos Dr. Doreski

Buenos Aires, C1426, Argentina

Location

Consultora Integral de Salud Centro Médico Privado

Córdoba, X5000KEH, Argentina

Location

Instituto CER S.A.

Quilmes, B1878DVB, Argentina

Location

AES - AS - Clinica Mayo de Urgencias

San Miguel de Tucumán, T4000IHE, Argentina

Location

CTR Estudios Clinicos

Santiago, 7500000, Chile

Location

Enroll SpA

Santiago, 8320000, Chile

Location

Centro de especialidades médicas Vanguardia

Temuco, 4810345, Chile

Location

Clinical Research Chile SpA

Valdivia, 683, Chile

Location

Centro de Estudios Clinicos Victoria Limitada (Cevic)

Victoria, 4720000, Chile

Location

Dermacross Clinica Dermatologica

Vitacura, 7640881, Chile

Location

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, 4032, Hungary

Location

Pécsi Tudomanyegyetem - Vasvari Pal u.

Pécs, 7622, Hungary

Location

Mediadvance Clinical

Chihuahua City, 31203, Mexico

Location

PanAmerican Clinical Research

Guadalajara, 44670, Mexico

Location

Medical Care and Research S.A. de C.V.

Mérida, 97070, Mexico

Location

Centro de Investigación y Tratamiento Reumatológico S.C

Miguel Hidalgo, 11850, Mexico

Location

Oaxaca Site Management Organization - Clinic - OSMO - PPDS

Oaxaca City, 68000, Mexico

Location

M2M Med-ul.

Chorzów, 41-500, Poland

Location

Malopolskie Badania Kliniczne Sp. z o.o.

Krakow, 30-002, Poland

Location

Malopolskie Centrum Kliniczne

Krakow, 30-149, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Santa Familia PTG Łódź

Lodz, 90-003, Poland

Location

Twoja Przychodnia NCM

Nowa Sól, 67-100, Poland

Location

Twoja Przychodnia PCM - ul.

Poznan, 60-324, Poland

Location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warsaw, 02-637, Poland

Location

Klinika Reuma Park sp . zoo Sp.k.

Warsaw, 02-665, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, B1000-874, Poland

Location

ClinHouse Centrum Medyczne

Zabrze, 41-807, Poland

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Dr I Cantacuzino Clinical Hospital

Bucharest, 030167, Romania

Location

Center for Clinical and Basic Research (CCBR)

Bucharest, 030463, Romania

Location

Sf.Maria Clinical Hospital

Bucharest, 11172, Romania

Location

Hiperdia Romania

Bucharest, 41303, Romania

Location

Policlinica SelfMed Clinique

Timișoara, 300133, Romania

Location

Institute of Rheumatology - PPDS

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Corporacio Sanitaria Parc Tauli

Barcelona, 08208, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Royal National Hospital for Rheumatic Diseases

Bath, BA1 3NG, United Kingdom

Location

Ninewells Hospital

Dundee, DD2 1SG, United Kingdom

Location

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Haywood Community Hospital

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Lung Diseases, Interstitial; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  Zura Bio Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 24, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); PL (11); RO (6); SE (2); HU (2); CL (6); US (7); GB (7); ME (5); AR (11)