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
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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)
Locations
United States
California
UCSD Altman Clinical and Translational Research Institute Center for Clinical Research
RECRUITING
La Jolla
Florida
IRIS Research and Development LLC
RECRUITING
Plantation
Iowa
University of Iowa
RECRUITING
Iowa City
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Texas
Rheumatology Associates
RECRUITING
Arlington
Other Locations
Argentina
Centro de Investigación y Prevención Cardiovascular-Arenales
RECRUITING
Buenos Aires
Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)