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. 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
- 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 6 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.
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 |
|---|---|---|
|
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
Boston University (BU)
Boston, Massachusetts 02215
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- Scleroderma Research Foundation, Inc.