NCT06843239 · Zura Bio Inc
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
What this study is about
The study is a Phase 2, multi-center, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an where both patients and doctors know the treatment given extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
View original scientific description
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)
Interventions
BIOLOGICAL
Tibulizumab
Anti BAFF/IL-17 antibody
OTHER
Placebo
Placebo (inactive)
Primary outcome measures
[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)
[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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, o
Where
- La Jolla, California
- Plantation, Florida
- Iowa City, Iowa
- Boston, Massachusetts
- Ann Arbor, Michigan
- Arlington, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations