Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Launched by ZURA BIO INC · Feb 20, 2025

Keywords

ClinConnect Summary

The TibuSURE trial is a clinical study looking at a new treatment called tibulizumab for people with systemic sclerosis (also known as scleroderma). This condition causes hardening and tightening of the skin and connective tissues, which can lead to various health issues. In this study, adults aged 18 to 70 who have been diagnosed with a specific type of systemic sclerosis will be randomly assigned to receive either tibulizumab or a placebo (a substance with no active treatment) for 24 weeks. Following this period, all participants will receive tibulizumab for an additional 28 weeks to see how it helps their condition.

To be eligible for this trial, participants must have a diagnosis of systemic sclerosis for no more than five years, and they should meet certain health criteria, like having specific symptoms and lung function levels. During the trial, participants will have regular check-ins to monitor their health and the effects of the treatment. It's important to note that individuals with certain severe health issues or other active diseases may not be able to join the study. This trial aims to gather more information about how effective tibulizumab is in treating systemic sclerosis and improving the quality of life for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, 18 to 70 years of age
• • Body mass index between 18.0 and 35.0 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 ≤5 years
• * Meets at least 1 of the following based on duration since SSc onset:
• • \<2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥15 and ≤45 at screening
• * ≥2 years from SSc onset (first non-RP symptom or sign attributed to SSc): mRSS ≥20 and ≤45 at screening, and either:
• • RNA polymerase III negative, or
• • Evidence of recent disease progression as defined in the protocol
• • 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, 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