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Tests treatment safety and results for Interstitial Lung Disease
Official title Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)
ClinicalTrials.gov ID: NCT05892614
What this study is testing
What is efzofitimod 450 mg?
efzofitimod 450 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for interstitial lung disease.
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 is a 2-Part study with Part A, a double-blind, randomized, placebo-controlled, PoC study to evaluate the efficacy, safety, and tolerability of efzofitimod in patients with SSc-ILD. The primary objective of the study is to evaluate the PoC for efficacy in a population with SSc-ILD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Diagnosis of SSc based on ACR/ EULAR criteria (2013)
- Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1
- HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with...
- Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
- MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to...
You likely can't join if
- Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7
- Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
- HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
- Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
- Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate [MTX], azathioprine [AZA], or leflunomide)
- Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab...
See the full eligibility criteria
- Diagnosis of SSc based on ACR/ EULAR criteria (2013)
- Overall duration of SSc \< 84 months from the first non-Raynaud symptom manifestation prior to Day 1
- HRCT obtained at the Screening Visit or within the 3 months prior to Screening consistent with SSc-ILD (adjudicated by a central reader) AND with pulmonary involvement \> 10%
- Clinical presentation at Screening consistent with lcSSc (up to 40% of patients) or dcSSc
- MMF of ≥ 2 gm/day (or equivalent doses of other mycophenolate based compounds) for 3 months prior to Day 1 OR When documented intolerance to mycophenolates (in discussion with the Medical Monitor): treatment with...
- Pulmonary disease with FVC %pred ≤ 45% OR DLco %pred ≤ 30%; FEV1/FVC ratio \< 0.7
- Participants with pulmonary artery hypertension on parenteral therapy or with clinical evidence of right heart failure
- HRCT obtained in the 3 months prior to Screening consistent with other confounding pathology.
- Treatment with corticosteroids (\> 10 mg/day of prednisone or equivalent) within 2 weeks prior to Day 1
- Treatment with more than 1 immunosuppressant (e.g., MMF, methotrexate [MTX], azathioprine [AZA], or leflunomide)
- Any treatment in the 12 months prior to Day 1 with any of the following: rituximab, intravenous immune globulin (IVIG), tocilizumab, cyclophosphamide, pirfenidone, tyrosine-kinase inhibitors (e.g., imatinib, nilotinib...
- Rheumatic autoimmune disease other than SSc, Is an active, heavy smoker of tobacco/nicotine-containing products
- History of (anti-Jo-1) anti-synthetase syndrome or Jo-1 positive at Screening
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Diego, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, 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 - 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?
Study sites include Los Angeles, California, United States; San Diego, California, United States; Miami, Florida, United States; Chicago, Illinois, United States; New Orleans, Louisiana, United States; New York, New York, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.