Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT07447102
Phase II Clinical Study of BC006 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing BC006 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- BC006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2026to 1 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 practice guideline.
- 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 screening period). If HRCT shows indeterminate UIP, the diagnosis of IPF must be confirmed by histopathology from a prior lung biopsy (surgical/video-assisted thoracoscopic lung biopsy or bronchoscopic cryobiopsy) recognized by the investigator, if available.
- 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.
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- 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 treatment, and plans to continue this background therapy during the study.
- 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 nintedanib or pirfenidone during the study. No patient should discontinue approved therapy to participate in this study. Treatment-naïve patients must decline after full discussion with the investigator regarding the risks/benefits of such therapy.
- 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 drug.
Who cannot join
- 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.
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- 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 efficacy.
- 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 York Heart Association (NYHA) functional Class ≥ III; previous evidence of left ventricular ejection fraction (LVEF) < 35%; uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or poor compliance with antihypertensive medications; acute coronary syndrome, stroke, or transient ischemic attack within 6 months prior to screening.
- 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 of the cervix, or other carcinoma in situ that has received curative treatment with no recurrence).
- 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 sclerosis, vasculitis, glomerulonephritis, etc., including but not limited to these diseases or syndromes).
- 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 (HCV-Ab) and HCV RNA > ULN.
- 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 evidence of recurrent disease).
- 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) within 4 weeks prior to screening or during the screening period.
- 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 P-glycoprotein (P-gp) inhibitors (e.g., ketoconazole, erythromycin) or inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's Wort) during screening or the study.
- Patients taking pirfenidone: using or planning to use strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin) or inducers (e.g., rifampicin) during screening or the study.
- 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 DLCO measurements; Twice-daily long-acting bronchodilators within 12 hours prior to spirometry and DLCO measurements.
- 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 in the study is not in the patient's best interest, in the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality
Xianfeng Feng, (+86)021-50870050, xianfeng.feng@dragonboatbio.com
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BC006 in Patients With Idiopathic Pulmonary Fibrosis
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
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- BC006, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC006Drug
A 1.0 mg/kg or 0.3 mg/kg IV infusion of BC006 based on the patients weight will be administered Q2W to Week 24.
PlaceboDrug
lacebo matching BC006 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
| Study group | Role | What they receive |
|---|---|---|
| BC006 | Experimental | Patients will receive intravenous (IV) infusions of BC006 once every 2 weeks (Q2W) to Week 24. ( for both safety run-in phase and randomized phase) Receives: Drug: BC006 |
| Placebo | Placebo comparator | Patients will receive intravenous (IV) infusions of Placebo once every 2 weeks (Q2W) to Week 24.( for randomized phase) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), as well as vital signs, physical examination, 12-lead ECG, and laboratory tests, etc.
For safety run-in phase
Measured: From Baseline up to Week 24
Absolute change in FVC (mL) from baseline in week 24
For randomized phase
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start27 Apr 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dragonboat Biopharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447102
- Sponsor's protocol ID
- BC006-II-01
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of BC006 in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07447102
- Acronym / sponsor ID
- BC006-II-01
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Dragonboat Biopharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BC006 | Experimental | Drug: BC006Patients will receive intravenous (IV) infusions of BC006 once every 2 weeks (Q2W) to Week 24. ( for both safety run-in phase and randomized phase) |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive intravenous (IV) infusions of Placebo once every 2 weeks (Q2W) to Week 24.( for randomized phase) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 practice guideline.
- 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 screening period). If HRCT shows indeterminate UIP, the diagnosis of IPF must be confirmed by histopathology from a prior lung biopsy (surgical/video-assisted thoracoscopic lung biopsy or bronchoscopic cryobiopsy) recognized by the investigator, if available.
- Forced vital capacity percent predicted (FVC% predicted) ≥45% during the screening period.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BC006A 1.0 mg/kg or 0.3 mg/kg IV infusion of BC006 based on the patients weight will be administered Q2W to Week 24. | Drug | BC006 |
| Placebolacebo matching BC006 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48. | Drug | Placebo |
Primary outcome
Adverse Events (AE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), as well as vital signs, physical examination, 12-lead ECG, and laboratory tests, etc.
Time frame: From Baseline up to Week 24
For safety run-in phase
Absolute change in FVC (mL) from baseline in week 24
Time frame: Week 24
For randomized phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BC006 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), as well as vital signs, physical examination, 12-lead ECG, and laboratory tests, etc. (time frame: From Baseline up to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.