Interstitial Lung Disease Due to Systemic Disease study: Amlitelimab vs BI
Official title Platform Clinical Study for Conquering Scleroderma
ClinicalTrials.gov ID: NCT06195072
What this study is testing
What is Amlitelimab?
An investigational once‑daily subcutaneous injectable medicine being studied for interstitial lung disease secondary to systemic sclerosis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the investigational products improve lung capacity in people with scleroderma-related lung disease.
- Who it's for
- You may be able to join if you have lung disease caused by scleroderma and are willing to try new treatments.
- What's involved
- You will receive one of the new treatments or a pretend treatment. You will have regular visits to check your lung function and health.
- Time commitment
- The study lasts 52 weeks, with visits at the start and at the end of the year to measure your lung capacity.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- 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)
You likely can't join if
- Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis [TB]...
- 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;
See the full eligibility criteria
- 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 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...
- 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
- Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- New Brunswick, New Jersey, United States
- Great Neck, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Los Angeles, California, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.