Last updated 5 months ago

Platform Clinical Study for Conquering Scleroderma

400 patients around the world

Available in United States, Chile

Scleroderma Research Foundation, Inc.

1Research sites

400Patients around the world

This study is for people with

Interstitial Lung Disease

Rare diseases

Scleroderma

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis, sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator).
Presence of infected ulcers or active gangrene at the Screening Visit.
History of scleroderma renal crisis within 6 months prior to the Screening Visit.
Forced expiratory volume in 1 second/FVC <0.65 (pre-bronchodilator) at the Screening Visit.
History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation.
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, anti-CD19, 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 6 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 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.
Presence of any of the following laboratory findings at the Screening Visit: Alanine aminotransferase or aspartate aminotransferase level > (2 x ULN).
Presence of any of the following laboratory findings at the Screening Visit: Platelets <100 × 109/L (100,000/μL).
Presence of any of the following laboratory findings at the Screening Visit: White blood cell count <2500/μL.
Presence of any of the following laboratory findings at the Screening Visit: Neutrophil blood count <1500/μL.
Presence of any of the following laboratory findings at the Screening Visit: Prothrombin time and partial thromboplastin time >1.5 × ULN, or international normalized ratio >2.
Presence of any of the following laboratory findings at the Screening Visit: Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study.
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.
Presence of a concomitant life-threatening disease with life expectancy <12 months based on the Investigator's assessment.
Evidence of active tuberculosis (TB) or being at high risk for TB.

Sites

Centro de Investigaciones Médicas Respiratorias (CIMER) - Chile

Recruiting

Matilde Salamanca 736, Providencia, Región Metropolitana, Chile

StudyCONQUEST

SponsorScleroderma Research Foundation, Inc.

Study typeInterventional

Conditions

Interstitial Lung DiseaseScleroderma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06195072