Platform Clinical Study for Conquering Scleroderma
- Conditions
- Interstitial Lung Disease Due to Systemic DiseaseScleroderma
- Interventions
- Registration Number
- NCT06195072
- Lead Sponsor
- Scleroderma Research Foundation, Inc.
- Brief Summary
The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
-
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);
-
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, 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 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;
- 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.
-
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
Other protocol and/or subprotocol exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlitelimab Amlitelimab - Amlitelimab matching placebo Placebo - BI 1015550 BI 1015550 - BI 1015550 matching placebo Placebo -
- Primary Outcome Measures
Name Time Method The change in forced vital capacity (FVC, in mL). from baseline to the end of the treatment period at Week 52
- Secondary Outcome Measures
Name Time Method The percent change in high-resolution computed tomography (HRCT) quantitative interstitial lung disease - whole lung (QILD-WL); from baseline to the end of the treatment period at Week 52 Lung involvement as measured by high-resolution computed tomography (HRCT) assessed by quantitative interstitial lung disease - whole lung (QILD-WL)
The change in Functional Assessment of Chronic Illness Therapy (FACIT)-Dyspnea score. from baseline to the end of the treatment period at Week 52 Dyspnea (severity and functional limitations) are measured by the Functional Assessment of Chronic Illness Therapy (FACIT) - Dyspnea score. Dyspnea score range 0-4, total score 0-30 (higher score = worse outcome).
The proportion of study participants with an improvement in the revised CRISS score, in study participants with diffuse cutaneous SSc and baseline mRRS ≥10. baseline, Week 52
Trial Locations
- Locations (32)
University of Alabama - Division of Pulmonary and Critical Care Medicine
🇺🇸Birmingham, Alabama, United States
Keck School of Medicine at USC Medical Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California, Los Angeles (UCLA) Ronald Reagan Medical Center
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Yale University School of Medicine - Epilepsy
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center - Department of Rheumatology
🇺🇸Washington, District of Columbia, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
The University of Chicago Medical Center (UCMC)
🇺🇸Chicago, Illinois, United States
University of Kansas School of Medicine
🇺🇸Kansas City, Kansas, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston University (BU)
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
🇺🇸Houston, Texas, United States
The University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Froedtert Hospital and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States