To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT05483907

Run by

Bridge Biotherapeutics, Inc.

People needed

129

Starts

2023-04-12

Expected to finish

2025-02-23

Last updated by the study team

2025-04-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Use of other medications likely to interfere with study assessments
• Any other current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results

Where it is running

• Severance Hospital Yonsei University — Seoul, South Korea
• 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
• Loyola University Medical Center — Maywood, Illinois, United States
• The Lung Research Center, LLC — Chesterfield, Missouri, United States
• Hannibal Regional Healthcare System-HRMG-Hannibal — Hannibal, Missouri, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Premier Pulmonary Critical Care & Sleep Medicine — Denison, Texas, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Royal Brisbane & Women's Hospital — Herston, Queensland, Australia
• Institute for Respiratory Health — Nedlands, Western Australia, Australia
• Meir Medical Center — Kfar Saba, Central District, Israel
• Lady Davis Carmel Medical Center — Haifa, Haifa District, Israel
• Hadassah Medical Center — Jerusalem, Jerusalem, Israel
• Tel Aviv Sourasky Medical Center — Ashkelon, Southern District, Israel
• Sheba Medical Center — Ramat Gan, Tel Aviv, Israel

Full record on ClinicalTrials.gov

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