BBT-877 for Idiopathic Pulmonary Fibrosis

No longer recruiting at 60 trial locations

Overseen By Bridge Biotherapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bridge Biotherapeutics, Inc.

Must be taking: Pirfenidone, Nintedanib

Disqualifiers: Current smoker, Emphysema, Congestive heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BBT-877 for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult and worsens over time. The study aims to determine if BBT-877 can improve breathing and lung function in these patients. Participants will receive either BBT-877 or a placebo (a pill with no active drug) and may already be taking other approved IPF medications like pirfenidone or nintedanib. This trial may suit someone diagnosed with IPF who can walk at least 150 meters and hasn't experienced improvement in their IPF over the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are on pirfenidone or nintedanib, you should have been on a stable dose for at least 4 weeks before screening. Other medications that might interfere with the study assessments may need to be stopped.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BBT-877 is being tested for safety and effectiveness in treating idiopathic pulmonary fibrosis (IPF). BBT-877 is a pill that blocks an enzyme linked to the disease. Since this treatment is in a Phase 2 study, earlier trials suggested it might be safe enough for broader testing.

In those earlier studies, most patients tolerated BBT-877 well, experiencing no serious side effects. However, detailed information about side effects from these studies has not been highlighted. As testing continues, researchers are closely monitoring its safety for people with IPF. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IPF?

BBT-877 is unique because it targets idiopathic pulmonary fibrosis (IPF) in a new way. Unlike current treatments like pirfenidone and nintedanib, which focus on reducing inflammation and fibrosis, BBT-877 works by inhibiting autotaxin, an enzyme involved in the production of molecules that promote fibrosis. This novel mechanism might offer an additional avenue to slow the progression of IPF. Researchers are excited about BBT-877 because it could potentially enhance treatment effectiveness when used alongside existing therapies, offering new hope for patients with this challenging condition.

What evidence suggests that BBT-877 might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that BBT-877, which participants in this trial may receive, might help treat idiopathic pulmonary fibrosis (IPF), a lung disease. Early results suggest that BBT-877 can slow the loss of lung function, measured by forced vital capacity (FVC). People with IPF often experience a decrease in FVC, so slowing this decline is promising. Although detailed results from human trials remain limited, this trial tests BBT-877 to see if it can improve lung health in IPF patients. Researchers are studying this treatment alongside a placebo, with both administered with or without existing approved therapies like pirfenidone and nintedanib. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

Your emphysema is more severe than your fibrosis.

I am not taking medications that could affect the study's results.

You are currently smoking tobacco or using e-cigarettes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200 mg twice daily of BBT-877 or placebo for 24 weeks

24 weeks

Visits at 0, 4, 12, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BBT-877
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: BBT-877 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

Who Is Running the Clinical Trial?

Bridge Biotherapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

560+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40404183/

Phase 2 study design and analysis approach for BBT-877 We are conducting a 24-week POC study with 120 patients with IPF, using a statistically supported sample size and incorporating exploratory CT-based imaging ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05483907

Study Details | NCT05483907 | To Evaluate the Efficacy, ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.03.31.25324971v1

Phase 2 Study Design and Analysis Approach for BBT-877 We are conducting a 24-week POC study with 120 patients with IPF, using a statistically supported sample size and incorporating exploratory computed tomography ...

4. rarediseaseadvisor.com rarediseaseadvisor.com/news/first-patient-ipf-given-bbt-877-phase-2a/

First Patient With IPF Given BBT-877 in Phase 2a Trial The first patient with idiopathic pulmonary fibrosis has been given BBT-877 in phase 2a clinical study to evaluate its efficacy, safety, ...

5. bridgebiorx.com bridgebiorx.com/en/board/board.php?bo_table=news_en&idx=51

Bridge Biotherapeutics, Inc. The primary objective is the evaluation of the efficacy of BBT-877 in IPF patients by measuring the reduction in forced vital capacity (FVC) in patients treated ...

6. ctv.veeva.com ctv.veeva.com/study/to-evaluate-the-efficacy-safety-and-tolerability-of-bbt-877-in-patients-with-ipf

To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of ...

7. prnewswire.com prnewswire.com/news-releases/bridge-biotherapeutics-announces-completion-of-enrollment-in-the-phase-2a-clinical-study-of-bbt-877-for-the-treatment-of-idiopathic-pulmonary-fibrosis-302208799.html

Bridge Biotherapeutics Announces Completion of ... BBT-877 is an orally administered autotaxin enzyme inhibitor which is under development as a treatment for idiopathic pulmonary fibrosis (IPF).