Platform Clinical Study for Conquering Scleroderma

Launched by SCLERODERMA RESEARCH FOUNDATION, INC. · Dec 22, 2023

Keywords

ClinConnect Summary

The "Platform Clinical Study for Conquering Scleroderma" is a clinical trial designed to investigate new treatments for patients suffering from Interstitial Lung Disease (ILD) caused by scleroderma, a condition that affects the skin and internal organs. The main goal of the study is to see how different investigational treatments compare to a placebo (a treatment with no active medication) in improving lung capacity over 52 weeks. This trial is currently recruiting participants aged 18 and older who have been diagnosed with scleroderma within the last five years, have certain lung function levels, and show evidence of lung fibrosis on a specific type of imaging test.

If you or a loved one are considering participating, it’s important to know that certain medical conditions or recent health issues may exclude you from the trial. Participants can expect to receive either an investigational treatment or a placebo during the study and will be monitored closely for changes in their lung health. This trial offers a chance to contribute to important research that may help improve treatments for scleroderma-related lung disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female 18+ years of age at the time of signed informed consent;
• • 2. 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
• • 3. Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;
• • 4. A Modified Rodnan skin score (mRSS) less than 40
• • 5. Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)
• • 6. Presence of an FVC 45% or more predicted normal;
• • 7. 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.
• Exclusion Criteria:
• • 1. 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);
• • 2. Presence of infected ulcers or active gangrene at the Screening Visit;
• • 3. History of scleroderma renal crisis within 6 months prior to the Screening Visit;
• • 4. Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit
• • 5. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
• • 6. History of treatment with rituximab within the 6 months prior to the Screening Visit;
• • 7. 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
• • 8. Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit
• • 9. 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.
• 10. 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.
• • 11. 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
• • 12. Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment;
• • 13. Evidence of active tuberculosis (TB) or being at high risk for TB
• • Other protocol and/or subprotocol exclusion criteria apply.