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New treatment option for Idiopathic Pulmonary Fibrosis (IPF)
Official title Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07447102
What this study is testing
What is BC006?
BC006 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idiopathic pulmonary fibrosis (ipf).
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 multicenter, Phase II clinical study to evaluate the efficacy and safety of BC006 over a 24-week treatment period in patients with idiopathic pulmonary fibrosis (IPF). The study consists of two phases: an open-label safety run-in phase and a double-blind, randomized, placebo-controlled phase.
- 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 40 and older
You may be able to join if
- Must provide written informed consent form (ICF) indicating understanding of the study and voluntary participation.
- Aged ≥40 years at the time of signing the ICF, with no gender restriction.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) according to the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory...
- HRCT pattern consistent with usual interstitial pneumonia (UIP) or probable UIP for IPF confirmed by independent central imaging review...
- Forced vital capacity percent predicted (FVC% predicted) ≥45% during the screening period.
You likely can't join if
- Interstitial lung disease of known etiology (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity, etc.).
- Other pulmonary diseases considered clinically significant by the investigator (e.g., asthma, chronic obstructive pulmonary disease, cavitary or...
- Emphysema ≥ 50%, or emphysema greater than fibrosis, as determined by independent central imaging review of HRCT.
- Acute exacerbation of IPF within 3 months prior to screening or during the screening period, as judged by the investigator.
- Sustained improvement in IPF severity within 12 months prior to screening or during the screening period, as judged by the investigator based on...
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \< 0.70 during the screening period.
See the full eligibility criteria
Who can join
- Must provide written informed consent form (ICF) indicating understanding of the study and voluntary participation.
- Aged ≥40 years at the time of signing the ICF, with no gender restriction.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) according to the 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Society (ATS/ERS/JRS/ALAT) clinical...
- HRCT pattern consistent with usual interstitial pneumonia (UIP) or probable UIP for IPF confirmed by independent central imaging review (acceptable-quality HRCT obtained within 12 months prior to screening or during the...
- Forced vital capacity percent predicted (FVC% predicted) ≥45% during the screening period.
- Diffusing capacity of the lung for carbon monoxide percent predicted (DLCO% predicted), corrected for hemoglobin (Hb), ≥30% and ≤90% during the screening period.
- Meets either of the following:
- The patient has been on a stable dose of nintedanib or pirfenidone for at least 8 weeks prior to screening and during screening (nintedanib ≥100 mg BID, pirfenidone ≥400 mg TID, no dose changes), tolerates the...
- The patient has not received nintedanib or pirfenidone for at least 4 weeks prior to screening and during screening (previous treatment discontinued or treatment-naïve), and does not plan to initiate or re-initiate...
- Patients of reproductive potential (male and female) must agree to use highly effective contraceptive methods (hormonal, barrier, or abstinence) from signing the ICF until at least 6 months after the last dose of study...
What rules you out
- Interstitial lung disease of known etiology (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity, etc.).
- Other pulmonary diseases considered clinically significant by the investigator (e.g., asthma, chronic obstructive pulmonary disease, cavitary or pleural disease, etc.).
- Emphysema ≥ 50%, or emphysema greater than fibrosis, as determined by independent central imaging review of HRCT.
- Acute exacerbation of IPF within 3 months prior to screening or during the screening period, as judged by the investigator.
- Sustained improvement in IPF severity within 12 months prior to screening or during the screening period, as judged by the investigator based on changes in FVC, DLCO, and/or chest HRCT scan.
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \< 0.70 during the screening period.
- Known increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL post-bronchodilator.
- History of smoking within 3 months prior to screening or during the screening period, or inability to refrain from smoking (including cigarettes, cigars, pipes, and e-cigarettes) for the duration of the study.
- Completed a cardiopulmonary rehabilitation program focusing on exercise training within 8 weeks prior to screening, or planning to initiate such a program during the study.
- Presence of pulmonary hypertension or cor pulmonale that, in the investigator's opinion, would significantly limit compliance with study requirements or may affect assessment of study safety or how well it works.
- History of lung volume reduction surgery or lung transplantation, or planning to undergo lung volume reduction surgery or lung transplantation during the study (patients on a lung transplant waiting list are permitted).
- Major surgery within 4 weeks prior to screening or during the screening period, or planning major surgery during the study (assessed as major surgery by the investigator).
- History of severe cardiovascular or cerebrovascular disease, including but not limited to: ventricular arrhythmia requiring clinical intervention; uncontrolled atrial arrhythmia; congestive heart failure meeting New...
- Current or suspected malignancy, or history of malignancy within 5 years prior to screening (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ...
- Active autoimmune disease, or history of autoimmune disease that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, autoimmune thyroid disease, multiple...
- Acute respiratory or systemic bacterial, viral, or fungal infection requiring antimicrobial therapy within 4 weeks prior to screening or during the screening period.
- Active hepatitis B or hepatitis C. Active hepatitis B is defined as positive hepatitis B surface antigen (HBsAg) and HBV DNA \> upper limit of normal (ULN). Active hepatitis C is defined as positive hepatitis C antibody...
- History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test.
- Positive interferon-γ release assay for tuberculosis during the screening period (testing is not required for patients who completed treatment for active or latent tuberculosis within 6 months prior to screening with no...
- Presence of any of the following laboratory abnormalities during the screening period: AST or ALT \> 1.5 × ULN; Total bilirubin \> 1.5 × ULN; Creatinine (Cr) \> 1.5 × ULN
- Prior treatment with a highly selective small-molecule CSF-1R inhibitor (excluding nintedanib), or anti-CSF-1/CSF-1R antibody.
- Known allergy or contraindication to the investigational product components or excipients, or history of hypersensitivity or severe infusion reaction to antibody-based products.
- Received an investigational drug within 4 weeks prior to screening or within 5 half-lives (whichever is longer) or during the screening period.
- Received other newly approved anti-fibrotic therapies other than nintedanib and pirfenidone within 4 weeks prior to screening or during the screening period, or planning to receive such therapies during the study.
- Received combination therapy with nintedanib and pirfenidone within 8 weeks prior to screening or during the screening period.
- Received cytotoxic, immunosuppressive, cytokine-modulating agents, or receptor antagonists (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, everolimus)...
- Received systemic corticosteroid therapy with prednisone \> 15 mg/day or equivalent within 4 weeks prior to screening or during the screening period. Patients taking nintedanib: using or planning to use strong...
- Unable to avoid use of the following medications: Short-acting bronchodilators within 4 hours prior to spirometry and DLCO measurements; Once-daily long-acting bronchodilators within 24 hours prior to spirometry and...
- Known or suspected history of alcohol or drug abuse within 2 years prior to screening or during the screening period.
- Pregnant (female patients of childbearing potential confirmed by serum pregnancy test within 7 days prior to first dose of study drug) or lactating female.
- Any disease, treatment, or abnormal laboratory finding that, in the investigator's opinion, may affect the patient's participation in the entire study, increase patient risk, or confound study results; or participation...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.