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 (51) 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
View:
• 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
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
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)
RECRUITING
Buenos Aires
Consultorios Médicos Dr. Doreski
RECRUITING
Buenos Aires
Hospital General de Agudos Dr. José María Ramos Mejia
RECRUITING
Buenos Aires
Instituto de Investigación Clínica TyT
RECRUITING
Buenos Aires
Organización Médica de Investigación
RECRUITING
Buenos Aires
STAT Research S.A.
RECRUITING
Buenos Aires
Consultora Integral de Salud Centro Médico Privado
RECRUITING
Córdoba
Instituto CER S.A.
RECRUITING
Quilmes
AES - AS - Clinica Mayo de Urgencias
RECRUITING
San Miguel De Tucumán
Centro de Investigaciones Médicas Tucumán
RECRUITING
San Miguel De Tucumán
Chile
CTR Estudios Clinicos
RECRUITING
Santiago
Enroll SpA
RECRUITING
Santiago
Centro de especialidades médicas Vanguardia
RECRUITING
Temuco
Clinical Research Chile SpA
RECRUITING
Valdivia
Centro de Estudios Clinicos Victoria Limitada (Cevic)
RECRUITING
Victoria
Dermacross Clinica Dermatologica
RECRUITING
Vitacura
Hungary
Pécsi Tudomanyegyetem - Vasvari Pal u.
RECRUITING
Pécs
Mexico
Mediadvance Clinical
RECRUITING
Chihuahua City
PanAmerican Clinical Research
RECRUITING
Guadalajara
Medical Care and Research S.A. de C.V.
RECRUITING
Mérida
Centro de Investigación y Tratamiento Reumatológico S.C
RECRUITING
Miguel Hidalgo
Oaxaca Site Management Organization - Clinic - OSMO - PPDS