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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4, 12, 24 weeks of treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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've had a detailed lung scan within the last year or during screening for IPF diagnosis.
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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.
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My lung condition hasn't improved in the last year.
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I have been on a stable dose of pirfenidone or nintedanib for at least 3 months, or I am not taking either.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 4, 12, 24 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4, 12, 24 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
Secondary outcome measures
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 more

Trial 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

BBT-877 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05483907 — Phase 2
Idiopathic Pulmonary Fibrosis Research Study Groups: Placebo, BBT-877
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: BBT-877 Highlights & Side Effects. Trial Name: NCT05483907 — Phase 2
BBT-877 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05483907 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity for enrollment in this clinical trial?

"The information accessible on clinicaltrials.gov reveals that this trial is actively searching for patients and has been since February 21st, 2023 with the last update being made a day earlier."

Answered by AI

Has the FDA sanctioned BBT-877 for therapeutic applications?

"Data collected to date suggests that BBT-877 is relatively safe, so it was allocated a score of 2. This Phase 2 trial has only been effective at proving the drug's safety and not its efficacy."

Answered by AI

What is the total sample size of this research experiment?

"Yes, the records hosted by clinicaltrials.gov verify that recruitment for this study is currently underway. It was first published on February 21st 2023 and has been amended as of February 20th 2023. The trial requires 120 participants from 2 different medical centres."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
National Jewish Health Main Campus
Loyola University Medical Center
Vanderbilt University Medical Center

Why did patients apply to this trial?

Looking for alternative medicines.. I am stable now but preparing for the worst...
PatientReceived 2+ prior treatments
~51 spots leftby Nov 2024