Actively Recruiting
Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis
Led by Dragonboat Biopharmaceutical Company Limited · Updated on 2026-05-13
96
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent to participate voluntarily.
- Aged 40 years or older at the time of consent.
- Diagnosis of idiopathic pulmonary fibrosis according to 2022 clinical practice guidelines.
- HRCT scan showing usual interstitial pneumonia or probable UIP pattern confirmed by central imaging review.
- Forced vital capacity (FVC) percent predicted of 45% or higher during screening.
- Lung diffusing capacity for carbon monoxide (DLCO) percent predicted between 30% and 90% during screening.
- Either stable use of nintedanib (≥100 mg twice daily) or pirfenidone (≥400 mg three times daily) for at least 8 weeks before screening and plans to continue during study; or no use of these drugs for at least 4 weeks before screening and no plans to start during study.
- Agreement by patients of reproductive potential to use highly effective contraception from consent until 6 months after last dose.
You will not qualify if you...
- Interstitial lung disease with known causes such as environmental exposures, connective tissue disease, or drug toxicity.
- Other significant lung diseases like asthma, COPD, cavitary or pleural disease.
- Emphysema involving 50% or more of lungs or greater than fibrosis on HRCT.
- Acute worsening of IPF within 3 months before or during screening.
- Sustained improvement in IPF severity within 12 months prior to or during screening.
- Pre-bronchodilator FEV1/FVC ratio less than 0.70.
- Known increase of FEV1 and/or FVC of 12% or more and 200 mL or more after bronchodilator.
- Smoking within 3 months before or during screening or inability to refrain from smoking during study.
- Recent or planned cardiopulmonary rehabilitation program.
- Pulmonary hypertension or cor pulmonale that could limit study participation or affect safety/efficacy assessment.
- History or planned lung volume reduction surgery or lung transplantation during study (except those on transplant waiting list).
- Major surgery within 4 weeks before or during screening or planned during study.
- Severe cardiovascular or cerebrovascular disease including certain arrhythmias, heart failure class III or higher, low heart ejection fraction, uncontrolled high blood pressure, recent heart attack or stroke within 6 months.
- Current or recent malignancy within 5 years except certain treated skin or bladder cancers.
- Active or relapsing autoimmune diseases.
- Recent serious infections requiring antimicrobial treatment.
- Active hepatitis B or C infections.
- History of immunodeficiency including positive HIV test.
- Positive tuberculosis test during screening unless completed treatment within 6 months.
- Elevated liver enzymes, bilirubin, or creatinine beyond set limits.
- Prior treatment with specific CSF-1R inhibitors or related antibodies.
- Known allergy or severe reaction to study drug components.
- Use of other investigational drugs recently.
- Use or planned use of newly approved anti-fibrotic therapies other than nintedanib or pirfenidone.
- Recent combination therapy with nintedanib and pirfenidone.
- Recent use of certain immunosuppressive or cytotoxic drugs.
- Recent use of high-dose systemic corticosteroids.
- Use of certain interacting medications with nintedanib or pirfenidone.
- Inability to avoid certain bronchodilators before lung function tests.
- History or suspicion of alcohol or drug abuse within 2 years.
- Pregnant or lactating women.
- Any condition or abnormality that may affect participation or increase risk as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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