RECRUITING

Platform Clinical Study for Conquering Scleroderma

Conditions

Interstitial Lung Disease Due to Systemic Disease Scleroderma platform interstitial lung disease systemic sclerosis SSc SSc-ILD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Platform Clinical Study for Conquering Scleroderma: a Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis

Quick Facts

Study Start:2024-04-15

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06195072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. An enrollment cap will apply to the limited/sine cutaneous SSc subtype. The enrollment cap will allow for equal or less than 30% of limited/sine cutaneous SSc subtype study participants for each Regimen-specific Subprotocol (IP); 3. Onset of SSc (defined by first non-Raynaud's symptom) 5 years or less prior to the Screening Visit; 4. Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc; 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;	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 otherfindings unrelated to SSc-ILD, as determined by a local radiologist/Investigator); 2. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation; 3. Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study; 4. History of Child-Pugh Class B or Class C liver disease; 5. 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 \>1.5 × upper limit of normal (ULN); * Platelets \<100 × 109/L (100,000/μL); * White blood cell count \<2500/μL; * Neutrophil blood count \<1500/μL; * Prolongation of 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. 6. History of major trauma or hemorrhage within 30 days of the Screening Visit; 7. History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit; 8. Presence of other clinically significant risk of bleeding events, including coagulation or platelet disorders, at the Screening Visit as determined by the Investigator; 9. History of any cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of the Screening Visit; 10. History of myocardial infarction or unstable angina within 6 months of the Screening Visit, or plans to undergo a coronary procedure during participation in the study; 11. Presence of acute or chronic congestive heart failure (New York Heart Association Class III \[moderate\] or Class IV \[severe\]) at the Screening Visit;

Inclusion Criteria

Exclusion 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. An enrollment cap will apply to the limited/sine cutaneous SSc subtype. The enrollment cap will allow for equal or less than 30% of limited/sine cutaneous SSc subtype study participants for each Regimen-specific Subprotocol (IP);
3. Onset of SSc (defined by first non-Raynaud's symptom) 5 years or less prior to the Screening Visit;
4. Modified Rodnan skin score (mRSS) of 10 to 35, inclusive, in participants with diffuse cutaneous SSc;
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;

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 otherfindings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);
2. History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;
3. Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;
4. History of Child-Pugh Class B or Class C liver disease;
5. 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 \>1.5 × upper limit of normal (ULN);
* Platelets \<100 × 109/L (100,000/μL);
* White blood cell count \<2500/μL;
* Neutrophil blood count \<1500/μL;
* Prolongation of 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.
6. History of major trauma or hemorrhage within 30 days of the Screening Visit;
7. History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit;
8. Presence of other clinically significant risk of bleeding events, including coagulation or platelet disorders, at the Screening Visit as determined by the Investigator;
9. History of any cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of the Screening Visit;
10. History of myocardial infarction or unstable angina within 6 months of the Screening Visit, or plans to undergo a coronary procedure during participation in the study;
11. Presence of acute or chronic congestive heart failure (New York Heart Association Class III \[moderate\] or Class IV \[severe\]) at the Screening Visit;

Contacts and Locations

Study Contact

Kelly Oliver

CONTACT

415.834.9444

inquiries@conquestssc.org

Principal Investigator

Kelly Oliver

STUDY_CHAIR

Scleroderma Research Foundation

Study Locations (Sites)

University of Alabama - Division of Pulmonary and Critical Care Medicine

Birmingham, Alabama, 35294

United States

Keck School of Medicine at USC Medical Center

Los Angeles, California, 90033

United States

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

University of California, Los Angeles (UCLA) Ronald Reagan Medical Center

Los Angeles, California, 90095-7436

United States

Stanford University Medical Center

Palo Alto, California, 94305

United States

Yale University School of Medicine - Epilepsy

New Haven, Connecticut, 06520

United States

Georgetown University Medical Center - Department of Rheumatology

Washington, District of Columbia, 20007

United States

Emory University School of Medicine

Atlanta, Georgia, 30322

United States

Northwestern University

Chicago, Illinois, 60611

United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, 60637

United States

University of Kansas School of Medicine

Kansas City, Kansas, 66160

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Boston University (BU)

Boston, Massachusetts, 02215

United States

University of Michigan

Ann Arbor, Michigan, 48109-0370

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901

United States

Northwell Health

Great Neck, New York, 11021

United States

Hospital for Special Surgery

New York, New York, 10021

United States

Columbia University Medical Center

New York, New York, 10032

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29404

United States

Meharry Medical College

Nashville, Tennessee, 37208

United States

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

Houston, Texas, 77030

United States

The University of Utah Health Sciences Center

Salt Lake City, Utah, 84112

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Scleroderma Research Foundation, Inc.

Kelly Oliver, STUDY_CHAIR, Scleroderma Research Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-15

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-04-15

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

platform
scleroderma
interstitial lung disease
systemic sclerosis
SSc
SSc-ILD

Additional Relevant MeSH Terms

Interstitial Lung Disease Due to Systemic Disease
Scleroderma