Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

a study on Systemic Sclerosis Scleroderma Diffuse Scleroderma Interstitial Lung Disease Autoimmune Disease

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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 for an additional 28 weeks (Period 2)

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

Keywords

Systemic Sclerosis (SSc), Scleroderma, Tibulizumab, Cutaneous, Interstitial lung disease (ILD), Autoimmune diseases, Immune system diseases, Systemic Sclerosis interstitial lung disease (SSC-ILD), Skin Diseases, Systemic Scleroderma, Diffuse Scleroderma, Interstitial Lung Diseases

Eligibility

You can join if…

Open to people ages 18-75

  • 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)

You CAN'T join if...

  • 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

Locations

  • UCSD Altman Clinical and Translational Research Institute Center for Clinical Research accepting new patients
    La Jolla 5363943 California 5332921 92037 United States
  • Rheumatology Associates accepting new patients
    Arlington 4671240 Texas 4736286 76012 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zura Bio Inc
Links
Related Info
ID
NCT06843239
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated