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Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Active Not RecruitingPhase 2

Sponsor: Zura Bio Inc

Conditions: Systemic Sclerosis (SSc), Scleroderma

Interventions: Tibulizumab, Placebo

Countries: United States, Argentina, Chile, Hungary, Mexico, Poland, Romania, Serbia

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (60)

La Jolla, California, United States
Los Angeles, California, United States
Plantation, Florida, United States
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Arlington, Texas, United States
Buenos Aires, Buenos Aires, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
Quilmes, Argentina
San Miguel de Tucumán, Argentina
Santiago, Chile
Santiago, Chile
Temuco, Chile
Valdivia, Chile
Victoria, Chile
Vitacura, Chile
Debrecen, Hungary
Pécs, Hungary
Chihuahua City, Mexico
Guadalajara, Mexico
Mérida, Mexico
Miguel Hidalgo, Mexico
+ 30 more on CT.gov