BBT-877 for Idiopathic Pulmonary Fibrosis

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Verified Trial

Waitlist Available

Sponsor: Bridge Biotherapeutics, Inc.

Prior Safety Data

Breakthrough Therapy

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

I am a man who does not plan to have more children or a woman aged 40 or older.

My condition is officially diagnosed as IPF by recognized guidelines.

I can walk 150 meters or more without stopping.

My oxygen levels are stable with minimal extra oxygen needed.

Exclusion Criteria

I have had a lung transplant or surgery to reduce lung volume.

I have a condition that weakens my immune system.

I have severe heart failure.

I am on medication for pulmonary hypertension.

Treatment Details

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.

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).