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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
129
In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
Change from baseline in FVC (in mL).
Time frame: After 24 weeks of treatment
In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo
Change from baseline in FVC (%).
Time frame: After 24 weeks of treatment
To evaluate the effect of on diffusing capacity of lung for carbon monoxide (DLCO) of BBT-877 compared to placebo
Change from baseline compared to placebo in DLCO
Time frame: After 24 weeks of treatment
To evaluate the effect on functional exercise capacity (measured by the 6-Minute Walk Test [6MWT]) of BBT-877 compared to placebo
Change from baseline in functional exercise capacity as measured by change in 6-minute walk distance assessed by the 6MWT
Time frame: After 24 weeks of treatment
To assess the change in IPF impacts from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
Change in overall respiratory health as measured by the St. George's Hospital Respiratory Questionnaire (SGRQ) total score from baseline and Change in overall IPF impacts as measured by the L-IPF total score from baseline
Time frame: after 24 weeks of treatment
To assess the change in IPF symptoms from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
Change in overall IPF symptoms as measured by the L-IPF total score from baseline
Time frame: after 24 weeks of treatment
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Pulmonary Associates P.A.
Phoenix, Arizona, United States
Southern Arizona VA Health Care System - NAVREF - PPDS
Tucson, Arizona, United States
Keck Medical Center of USC
Los Angeles, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
National Jewish Health Main Campus
Denver, Colorado, United States
St. Francis Medical Institute - Clinedge
Clearwater, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Central Florida Pulmonary Group PA
Orlando, Florida, United States
Augusta University
Augusta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
...and 34 more locations
To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF
Pre-dose and 4 hr-post dose of plasma concentrations
Time frame: 0, 4, 12, 24 weeks of treatment
To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF
Pre-dose and 4 hr-post dose of plasma concentrations.
Time frame: 0, 4, 12, 24 weeks of treatment
To assess the safety of BBT-877 compared to placebo
The investigator will be asked to provide an assessment of the severity of the AE using the following categories: Mild: Usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate: Usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the patient. Severe: Interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame: over 24 weeks