Platform Clinical Study for Conquering Scleroderma

Korábbi kezelés

• Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis \[TB\], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
• History of scleroderma renal crisis within 6 months prior to the Screening Visit;
• History of treatment with rituximab within the 6 months prior to the Screening Visit;
• History treatment with cell-depleting therapies other than rituximab, including, but not limited to, CAMPATH®; anti-cluster of differentiation (CD)3, anti-CD4, anti-CD5, antiCD19, and anti-CD20 agents; and investigational agents
• Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit
• History of use of any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer) prior to Screening Visit.
• Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment;

Más betegség

• Presence of infected ulcers or active gangrene at the Screening Visit;
• History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
• Presence of a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study product, affect compliance, interfere with study evaluations, or confound the interpretation of study results
• Evidence of active tuberculosis (TB) or being at high risk for TB
  • Other protocol and/or subprotocol exclusion criteria apply.

Laborértékek

• Presence of any of the following laboratory findings at the Screening Visit:
  • Estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
  • Alanine aminotransferase or aspartate aminotransferase level \> (2 x ULN);
  • Platelets \<100 × 109/L (100,000/μL);
  • White blood cell count \<2500/μL;
  • Neutrophil blood count \<1500/μL;
  • Prothrombin time and partial thromboplastin time \>1.5 × ULN, or international normalized ratio \>2; or
  • Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study.

Egyéb

• Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit

• Male or female 18+ years of age at the time of signed informed consent;
• SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible
• Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
• A Modified Rodnan skin score (mRSS) less than 40
• Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
• Presence of an FVC 45% or more predicted normal;
• Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin;
  • Other protocol and/or subprotocol inclusion criteria apply.