To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
NCT ID: NCT05483907
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2023-04-12
2025-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BBT-877
200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
BBT-877
BBT-877 24 weeks + Follow-up 4 weeks
Placebo
200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
Placebo
Placebo 24 weeks + Follow-up 4 weeks
Interventions
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BBT-877
BBT-877 24 weeks + Follow-up 4 weeks
Placebo
Placebo 24 weeks + Follow-up 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Bridge Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
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
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
Barzilai Medical Center
Petah Tikva, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz
Będzin, Silesian Voivodeship, Poland
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, , Poland
Soon Chun Hyang University Hospital Seoul
Cheonan, Chungcheongnam-do, South Korea
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Myongji Hospital
Goyang-si, Gyeonggido, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Gachon University Gil Medical Center
Namdong, Incheon, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Yeongdeungpo-dong, Seoul, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University
Seoul, , South Korea
Countries
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References
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Maher T, Song JW, Kramer MR, Lancaster L, Corte TJ, Yun J, Kim K, Cho J, Sather LF, George PM, Devaraj A, Jung JH, Jung S. Phase 2 study design and analysis approach for BBT-877: an autotaxin inhibitor targeting idiopathic pulmonary fibrosis. BMJ Open Respir Res. 2025 May 22;12(1):e003038. doi: 10.1136/bmjresp-2024-003038.
Other Identifiers
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BBT877-IPF-004
Identifier Type: -
Identifier Source: org_study_id
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