Last updated 6 days ago

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

80 patients around the world

Available in Argentina, United States

Zura Bio Inc

1Research sites

80Patients around the world

This study is for people with

Rare diseases

Systemic sclerosis

To 75 Years

All Gender

: 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 mayor al 50% predicted.
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin).

: 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.

Consultorios Médicos Dr. Doreski

Recruiting

Av. Cabildo, Cdad. Autónoma de Buenos Aires, Argentina

SponsorZura Bio Inc

Study typeInterventional

Conditions

Systemic sclerosis

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06843239