BBT-877 for Idiopathic Pulmonary Fibrosis

Recruiting at 43 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

129 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+