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Tyrosine Kinase Inhibitor
BBT-877 for Idiopathic Pulmonary Fibrosis
Verified Trial
Phase 2
Recruiting
Research Sponsored by Bridge Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male patients who have completed family planning or female patient, aged 40 years or older
Diagnosis of IPF in accordance with American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for diagnosis in effect at the time of screening
Must not have
History of lung transplant or lung volume reduction surgery
Current immunosuppressive condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4, 12, 24 weeks of treatment
Summary
This trial will evaluate a potential new treatment for IPF with or without AF, to see if it's safe and effective.
Who is the study for?
This trial is for men who are done with family planning or women aged 40+, diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to specific guidelines. Participants must be able to walk at least 150 meters and have a certain level of lung function. They can't join if they have other serious health issues, require pulmonary hypertension therapy, had a lung transplant, currently smoke, or have used certain medications recently.
What is being tested?
The study tests the effectiveness of BBT-877 taken twice daily compared to a placebo in IPF patients. It's double-blind meaning neither the researchers nor participants know who gets the real drug versus placebo. The trial includes those on standard IPF treatments as well as those not being treated.
What are the potential side effects?
While specific side effects for BBT-877 aren't listed here, common ones in trials like this may include gastrointestinal symptoms, skin reactions, liver enzyme changes, fatigue and potential risks associated with immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man who does not plan to have more children or a woman aged 40 or older.
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My condition is officially diagnosed as IPF by recognized guidelines.
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I can walk 150 meters or more without stopping.
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My oxygen levels are stable with minimal extra oxygen needed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a lung transplant or surgery to reduce lung volume.
Select...
I have a condition that weakens my immune system.
Select...
I have severe heart failure.
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I am on medication for pulmonary hypertension.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 4, 12, 24 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 4, 12, 24 weeks of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
Secondary study objectives
In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo
To assess the change in IPF impacts from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
To assess the change in IPF symptoms from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BBT-877Experimental Treatment1 Intervention
200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
Group II: PlaceboPlacebo Group1 Intervention
200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BBT-877
2019
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Bridge Biotherapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
433 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
88 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your emphysema is more severe than your fibrosis.I am not taking medications that could affect the study's results.Your lung function should be at least 45% of what is expected for someone of your age and size.Your lung function test shows that the amount of air you can breathe out quickly is normal compared to the total amount of air you can breathe out.Your lung function test result (DLCO) is at least 30% of what's expected for someone your age and size.You are currently smoking tobacco or using e-cigarettes.My lung condition hasn't improved in the last year.I have been on a stable dose of pirfenidone or nintedanib for at least 3 months, or I am not taking either.The doctor thinks you have less than a year or less than 2 and a half years to live.I am on medication for pulmonary hypertension.I have had a lung transplant or surgery to reduce lung volume.I have severe heart failure.I haven't had any major heart, lung, or other serious health issues in the last 6 months.You are not able to do the breathing test called spirometry as per the American Thoracic Society guidelines.My lung condition has worsened in the last 3 months.I am a man who does not plan to have more children or a woman aged 40 or older.My oxygen levels are stable with minimal extra oxygen needed.I can walk 150 meters or more without stopping.My condition is officially diagnosed as IPF by recognized guidelines.I've had a detailed lung scan within the last year or during screening for IPF diagnosis.I have a condition that weakens my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: BBT-877
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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