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

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)

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 Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: BBT-877; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Royal Brisbane & Women's Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Institute for Respiratory Health
• Israel
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center
  • Petah Tikva, Israel, 4910000
    • Barzilai Medical Center
  • Petah tikva, Israel, 49100
    • Rabin Medical Center
  • Reẖovot, Israel, 76100
    • Kaplan Medical Center
  • HaDarom
    • Ashkelon, HaDarom, Israel, 78278
      • Tel Aviv Sourasky Medical Center
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 44281
      • Meir Medical Center
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 52621
      • Sheba Medical Center
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
      • Soon Chun Hyang University Hospital Seoul
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06351
      • Samsung Medical Center
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 14647
      • The Catholic University of Korea, Bucheon St. Mary's Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13497
      • CHA Bundang Medical Center, CHA University
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10475
      • Myongji Hospital
  • Gyeongsangnamdo
    • Yangsan, Gyeongsangnamdo, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital
  • Incheon
    • Namdong, Incheon, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
  • Seongbuk-gu
    • Seoul, Seongbuk-gu, Korea, Republic of, 02841
      • Korea University Anam Hospital
  • Seoul
    • Yeongdeungpo-dong, Seoul, Korea, Republic of, 07345
      • The Catholic University of Korea - Eunpyeong St. Mary's Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center
• Poland
  • Bydgoszcz, Poland, 85-681
    • Vitamed Galaj I Cichomski sp.j.
  • Slaskie
    • Będzin, Slaskie, Poland, 42-500
      • Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006-2611
      • Pulmonary Associates P.A.
    • Tucson, Arizona, United States, 85723-0001
      • Southern Arizona VA Health Care System - NAVREF - PPDS
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System
  • Colorado
    • Denver, Colorado, United States, 80206-2761
      • National Jewish Health Main Campus
  • Florida
    • Clearwater, Florida, United States, 33765
      • St. Francis Medical Institute - Clinedge
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32803-5443
      • Central Florida Pulmonary Group PA
  • Georgia
    • Augusta, Georgia, United States, 30912-0004
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60611-2993
      • Northwestern Memorial Hospital
    • Maywood, Illinois, United States, 60153-3328
      • Loyola University Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017-3632
      • The Lung Research Center, LLC
    • Hannibal, Missouri, United States, 63401-6890
      • Hannibal Regional Healthcare System-HRMG-Hannibal
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8900
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University Medical Center
  • Texas
    • Denison, Texas, United States, 75020
      • Premier Pulmonary Critical Care & Sleep Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBT-877; 200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).	Drug: BBT-877; BBT-877 24 weeks + Follow-up 4 weeks
Placebo Comparator: Placebo; 200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).	Drug: Placebo; Placebo 24 weeks + Follow-up 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo	Change from baseline in FVC (%).	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	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	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	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	after 24 weeks of treatment
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	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.	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.	over 24 weeks

Collaborators and Investigators

• Sponsor: Bridge Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): January 26, 2025
• Study Completion (Actual): February 23, 2025

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: BBT877-IPF-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No