Actively Recruiting
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Led by Zura Bio Inc · Updated on 2026-02-12
80
Participants Needed
51
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 to 75 years of age
- Body mass index between 18.0 and 38.0 kg/m8
- Meets classification criteria for systemic sclerosis according to ACR/EULAR 2013
- Has diffuse cutaneous systemic sclerosis with skin involvement proximal to elbows or knees plus acral fibrosis
- Has had systemic sclerosis for 7 years or less since first non-Raynaud's symptom
- Modified Rodnan Skin Score between 15 and 45 at screening (with additional criteria if 2 to 7 years from onset and RNA Polymerase III antibody positive)
- Forced vital capacity greater than 50% predicted
- Lung diffusing capacity (DLCO) at least 40% predicted, corrected for hemoglobin
You will not qualify if you...
- 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
- Other rheumatic diseases that could affect assessment of systemic sclerosis
- Lung disease requiring continuous oxygen therapy
- Active or latent tuberculosis
- Active Crohn's Disease or ulcerative colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
UCSD Altman Clinical and Translational Research Institute Center for Clinical Research
La Jolla, California, United States, 92037
Actively Recruiting
2
IRIS Research and Development LLC
Plantation, Florida, United States, 33324
Actively Recruiting
3
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Rheumatology Associates
Arlington, Texas, United States, 76012
Actively Recruiting
7
STAT Research S.A.
Buenos Aires, Buenos Aires, Argentina, C1023
Actively Recruiting
8
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
Actively Recruiting
9
Organización Médica de Investigación
Buenos Aires, Argentina, C1015
Actively Recruiting
10
Centro de Investigación y Prevención Cardiovascular-Arenales
Buenos Aires, Argentina, C1061
Actively Recruiting
11
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Argentina, C1221AFC
Actively Recruiting
12
Instituto de Investigación Clínica TyT
Buenos Aires, Argentina, C1405BFN
Actively Recruiting
13
Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)
Buenos Aires, Argentina, C1426ABP
Actively Recruiting
14
Consultorios Médicos Dr. Doreski
Buenos Aires, Argentina, C1426
Actively Recruiting
15
Consultora Integral de Salud Centro Médico Privado
Córdoba, Argentina, X5000KEH
Actively Recruiting
16
Instituto CER S.A.
Quilmes, Argentina, B1878DVB
Actively Recruiting
17
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
18
CTR Estudios Clinicos
Santiago, Chile, 7500000
Actively Recruiting
19
Enroll SpA
Santiago, Chile, 8320000
Actively Recruiting
20
Centro de especialidades médicas Vanguardia
Temuco, Chile, 4810345
Actively Recruiting
21
Clinical Research Chile SpA
Valdivia, Chile, 683
Actively Recruiting
22
Centro de Estudios Clinicos Victoria Limitada (Cevic)
Victoria, Chile, 4720000
Actively Recruiting
23
Dermacross Clinica Dermatologica
Vitacura, Chile, 7640881
Actively Recruiting
24
Pécsi Tudomanyegyetem - Vasvari Pal u.
Pécs, Hungary, 7622
Actively Recruiting
25
Mediadvance Clinical
Chihuahua City, Mexico, 31203
Actively Recruiting
26
PanAmerican Clinical Research
Guadalajara, Mexico, 44670
Actively Recruiting
27
Medical Care and Research S.A. de C.V.
Mérida, Mexico, 97070
Actively Recruiting
28
Centro de Investigación y Tratamiento Reumatológico S.C
Miguel Hidalgo, Mexico, 11850
Actively Recruiting
29
Oaxaca Site Management Organization - Clinic - OSMO - PPDS
Oaxaca City, Mexico, 68000
Actively Recruiting
30
M2M Med-ul.
Chorzów, Poland, 41-500
Actively Recruiting
31
Malopolskie Badania Kliniczne Sp. z o.o.
Krakow, Poland, 30-002
Actively Recruiting
32
Malopolskie Centrum Kliniczne
Krakow, Poland, 30-149
Actively Recruiting
33
Centrum Medyczne Plejady
Krakow, Poland, 30-363
Actively Recruiting
34
Twoja Przychodnia PCM - ul.
Poznan, Poland, 60-324
Actively Recruiting
35
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Poland, 02-665
Actively Recruiting
36
MICS Centrum Medyczne Warszawa
Warsaw, Poland, B1000-874
Actively Recruiting
37
Center for Clinical and Basic Research (CCBR)
Bucharest, Romania, 030463
Actively Recruiting
38
Sf.Maria Clinical Hospital
Bucharest, Romania, 11172
Actively Recruiting
39
Hiperdia Romania
Bucharest, Romania, 41303
Actively Recruiting
40
Institute of Rheumatology - PPDS
Belgrade, Serbia, 11000
Actively Recruiting
41
Military Medical Academy
Belgrade, Serbia, 11000
Actively Recruiting
42
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
43
Corporacio Sanitaria Parc Tauli
Barcelona, Spain, 08208
Actively Recruiting
44
Hospital Quironsalud Infanta Luisa
Seville, Spain, 41010
Actively Recruiting
45
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
46
Royal National Hospital for Rheumatic Diseases
Bath, United Kingdom, BA1 3NG
Actively Recruiting
47
Ninewells Hospital
Dundee, United Kingdom, DD2 1SG
Actively Recruiting
48
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
49
Aintree University Hospital
Liverpool, United Kingdom, L9 7AL
Actively Recruiting
50
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
51
Haywood Community Hospital
Stoke-on-Trent, United Kingdom, ST6 7AG
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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