A Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as Mono- or add-on Therapy, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Bridge Biotherapeutics, Inc.44 sites in 5 countries129 target enrollmentApril 12, 2023

ConditionsIdiopathic Pulmonary Fibrosis

InterventionsBBT-877 Placebo

DrugsBBT-877 Placebo

Overview

Phase: Phase 2
Intervention: BBT-877
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Bridge Biotherapeutics, Inc.
Enrollment: 129
Locations: 44
Primary Endpoint: In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

April 12, 2023

End Date

February 23, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bridge Biotherapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Chest high-resolution computed tomography (HRCT) performed according to ATS guidelines within 12 months prior to screening and according to minimum requirements for IPF diagnosis by central review based on HRCT and lung biopsy. If no historical acceptable HRCT is available prior to screening, an HRCT can be performed during screening. In both cases, a central reading of the HRCT has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis.
•Able to walk at least 150 meters during the 6MWT at screening
•Resting oxygen saturation of ≥89% using a maximum of 6 L/min of supplemental oxygen at sea level, and up to 8 L/min at altitude during screening
•FVC ≥45% predicted of normal
•Ratio of forced expiratory volume in the first second (FEV1) to FVC ≥0.7
•Diffusing capacity for the DLCO corrected for hemoglobin ≥30% predicted of normal
•Absence of IPF improvement in the past year, as determined by the investigator
•Patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, OR taking neither pirfenidone

Exclusion Criteria

•Unable to perform spirometry as per ATS
•Evidence of IPF exacerbation within 3 months prior to and/or during screening
•Evidence of emphysema extent greater than the extent of fibrosis
•Current smoker (tobacco, e-cigarette)
•History of lung transplant or lung volume reduction surgery
•Current immunosuppressive condition
•Estimated life expectancy of less than 12 months or 30 months in the opinion of the investigator
•Congestive heart failure class III or IV according to New-York Heart Association classification
•Pulmonary hypertension (PH) requiring PH specific therapy
•Unstable cardiovascular, pulmonary or other disease within 6 months prior to screening or during the screening period

Arms & Interventions

BBT-877

200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

Intervention: BBT-877

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo

Time Frame: After 24 weeks of treatment

Change from baseline in FVC (in mL).

Secondary Outcomes

In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo(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(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(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(after 24 weeks of treatment)
To assess the safety of BBT-877 compared to placebo(over 24 weeks)
To evaluate the effect on functional exercise capacity (measured by the 6-Minute Walk Test [6MWT]) of BBT-877 compared to placebo(After 24 weeks of treatment)
To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF(0, 4, 12, 24 weeks of treatment)
To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF(0, 4, 12, 24 weeks of treatment)