RECRUITINGPhase 2INTERVENTIONAL
Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
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
About This Trial
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)
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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)
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
Treatments Being Tested
BIOLOGICAL
Tibulizumab
Anti BAFF/IL-17 antibody
OTHER
Placebo
Placebo (inactive)
Locations (20)
UCSD Altman Clinical and Translational Research Institute Center for Clinical Research
La Jolla, California, United States
IRIS Research and Development LLC
Plantation, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Rheumatology Associates
Arlington, Texas, United States
STAT Research S.A.
Buenos Aires, Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Tucumán Province, Argentina
Organización Médica de Investigación
Buenos Aires, Argentina
Centro de Investigación y Prevención Cardiovascular-Arenales
Buenos Aires, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Argentina
Instituto de Investigación Clínica TyT
Buenos Aires, Argentina
Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)
Buenos Aires, Argentina
Consultorios Médicos Dr. Doreski
Buenos Aires, Argentina
Consultora Integral de Salud Centro Médico Privado
Córdoba, Argentina
Instituto CER S.A.
Quilmes, Argentina
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Argentina
CTR Estudios Clinicos
Santiago, Chile
Enroll SpA
Santiago, Chile
Centro de especialidades médicas Vanguardia
Temuco, Chile