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NCT06843239

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Active, Not Recruiting
PHASE2Ages 18–75InterventionalTreatment
Zura Bio Inc
~80 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:TibulizumabPlacebo

At a glance

Recruiting sites
0 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[Period 1] Change from baseline in modified Rodnan Skin Score (mRSS) at 24 weeks
Measured over Week 24
+1 more outcome measured

Conditions

Systemic Sclerosis (SSc)
Scleroderma

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Systemic SclerodermaRNA Polymerase III

Where it's being run

60 sites across 17 states
Poland11
Argentina9
United Kingdom7
Chile6
Romania6
Mexico5
Spain3
California2

Study leadership

  • Study Director · STUDY_DIRECTOR · Zura Bio Inc

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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