AzTrials
AzTrials

Systemic Sclerosis (SSc)Phase 2NCT06843239

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

A Phase 2 study testing Tibulizumab in people with Systemic Sclerosis (SSc) and Scleroderma, run by Zura Bio Inc at 60 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Sclerosis (SSc), Scleroderma
What is being tested?
Tibulizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
60 sitesin 10 countries
Study dates
6 Feb 2025to Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

60 sites in 10 countries.

60 sites in 10 countries

Argentina11 sites

  • STAT Research S.A.

    Buenos Aires, Buenos Aires, C1023

  • Organización Médica de Investigación

    Buenos Aires, C1015

  • Centro de Investigación y Prevención Cardiovascular-Arenales

    Buenos Aires, C1061

  • Hospital General de Agudos Dr. José María Ramos Mejia

    Buenos Aires, C1221AFC

  • Instituto de Investigación Clínica TyT

    Buenos Aires, C1405BFN

  • Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)

    Buenos Aires, C1426ABP

  • Consultorios Médicos Dr. Doreski

    Buenos Aires, C1426

  • Consultora Integral de Salud Centro Médico Privado

    Córdoba, X5000KEH

  • Instituto CER S.A.

    Quilmes, B1878DVB

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • AES - AS - Clinica Mayo de Urgencias

    San Miguel de Tucumán, T4000IHE

Other trials in Argentina

Poland11 sites

  • M2M Med-ul.

    Chorzów, 41-500

  • Malopolskie Badania Kliniczne Sp. z o.o.

    Krakow, 30-002

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Santa Familia PTG Łódź

    Lodz, 90-003

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100

  • Twoja Przychodnia PCM - ul.

    Poznan, 60-324

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, 02-665

  • MICS Centrum Medyczne Warszawa

    Warsaw, B1000-874

  • ClinHouse Centrum Medyczne

    Zabrze, 41-807

Other trials in Poland

United States7 sites

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • Rheumatology Associates

    Arlington, Texas, 76012

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Iowa

    Iowa City, Iowa, 52242

  • UCSD Altman Clinical and Translational Research Institute Center for Clinical Research

    La Jolla, California, 92037

  • UCLA Department of Medicine

    Los Angeles, California, 90024

  • IRIS Research and Development LLC

    Plantation, Florida, 33324

Other trials in United States

United Kingdom7 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Royal National Hospital for Rheumatic Diseases

    Bath, BA1 3NG

  • Ninewells Hospital

    Dundee, DD2 1SG

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Aintree University Hospital

    Liverpool, L9 7AL

  • Royal Free Hospital

    London, NW3 2QG

  • Haywood Community Hospital

    Stoke-on-Trent, ST6 7AG

Other trials in United Kingdom

Chile6 sites

  • CTR Estudios Clinicos

    Santiago, 7500000

  • Enroll SpA

    Santiago, 8320000

  • Centro de especialidades médicas Vanguardia

    Temuco, 4810345

  • Clinical Research Chile SpA

    Valdivia, 683

  • Centro de Estudios Clinicos Victoria Limitada (Cevic)

    Victoria, 4720000

  • Dermacross Clinica Dermatologica

    Vitacura, 7640881

Other trials in Chile

Romania6 sites

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Dr I Cantacuzino Clinical Hospital

    Bucharest, 030167

  • Center for Clinical and Basic Research (CCBR)

    Bucharest, 030463

  • Sf.Maria Clinical Hospital

    Bucharest, 11172

  • Hiperdia Romania

    Bucharest, 41303

  • Policlinica SelfMed Clinique

    Timișoara, 300133

Other trials in Romania

Mexico5 sites

  • Mediadvance Clinical

    Chihuahua City, 31203

  • PanAmerican Clinical Research

    Guadalajara, 44670

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

    Mérida, 97070

  • Centro de Investigación y Tratamiento Reumatológico S.C

    Miguel Hidalgo, 11850

  • Oaxaca Site Management Organization - Clinic - OSMO - PPDS

    Oaxaca City, 68000

Other trials in Mexico

Spain3 sites

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08025

  • Corporacio Sanitaria Parc Tauli

    Barcelona, 08208

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

Other trials in Spain

Hungary2 sites

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, 4032

  • Pécsi Tudomanyegyetem - Vasvari Pal u.

    Pécs, 7622

Other trials in Hungary

Serbia2 sites

  • Institute of Rheumatology - PPDS

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: 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)

Being tested
Tibulizumab, Placebo
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
Medical subject headings
Scleroderma, Systemic, Scleroderma, Diffuse, Lung Diseases, Interstitial, Autoimmune Diseases, Immune System Diseases, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TibulizumabBiological

    Also called ZB-106

    Anti BAFF/IL-17 antibody

  • PlaceboOther

    Also called ZB-106 placebo

    Placebo (inactive)

Study groups in NCT06843239
Study groupRoleWhat they receive
TibulizumabExperimentalSubcutaneous injection
Receives: Biological: Tibulizumab
PlaceboPlacebo comparatorSubcutaneous injection
Receives: Biological: Tibulizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [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)

    Measured: Week 24

  2. [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

    Measured: Week 52

Secondary outcomes (6)

  1. [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)

    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)

    Measured: Week 24

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

    FVC is the amount of air that can be forcibly exhaled after the deepest possible breath

    Measured: Week 24

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

    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

    Measured: Week 24

  4. [Period 1] Safety and tolerability of tibulizumab

    Assessed by the incidence of all TEAEs, as well as changes from baseline in vital signs, ECG parameters, and laboratory results

    Measured: Week 24

  5. [Period 2] Change from baseline in mRSS

    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)

    Measured: Week 52

  6. [Period 2] Change from baseline in QILD obtained with HRCT in the whole lung in participants with SSc-ILD

    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)

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start6 Feb 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06843239
Sponsor's protocol ID
ZB-106-SS-201
Other IDs
2024-519335-42-01
Status last verified
Jul 2026
First submitted
7 Feb 2025
Last updated
20 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tibulizumab in people with Systemic Sclerosis (SSc) and Scleroderma, run by Zura Bio Inc at 60 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Argentina, Poland, United States, United Kingdom, Chile and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06843239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in