Platform Clinical Study for Conquering Scleroderma
Purpose
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.
Conditions
- Interstitial Lung Disease Due to Systemic Disease
- Scleroderma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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; Other protocol and/or subprotocol inclusion criteria apply.
Exclusion Criteria
- 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; Other protocol and/or subprotocol exclusion criteria apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants who have given informed consent for the Master Protocol and all available Regimen-specific Subprotocols for which they are eligible will be randomly assigned to a regimen. Within each regimen, participants will be assigned to active treatment or matching placebo in a ratio detailed in the randomization scheme. Eligibility for the Regimen will be based on the inclusion and exclusion criteria in the Master Protocol and on the inclusion and exclusion criteria in the Regimen-specific Subprotocol. Importantly, to preserve the integrity of randomization, participants will be consented to all possible Regimen-specific Subprotocols open at that time, for which they qualify. Eligible participants will then be randomized to only one Regimen-specific Subprotocol, followed by randomization to the active IP treatment or to the corresponding placebo within a Regimen-specific Subprotocol.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- There will be multiple interventional regimens, each consisting of the study participants receiving either the active IP or its matching placebo. Study participants, Investigators, and site staff will not be blinded to the regimen assignment, but they will be blinded to active product or matching placebo assignment. Enrollment to regimens may start at different time points during the study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Amlitelimab |
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Placebo Comparator Amlitelimab matching placebo |
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Experimental BI 1015550 |
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Placebo Comparator BI 1015550 matching placebo |
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Recruiting Locations
University of Alabama - Division of Pulmonary and Critical Care Medicine
Birmingham, Alabama 35294
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Scleroderma Research Foundation, Inc.