To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
- Registration Number
- NCT05483907
- Lead Sponsor
- Bridge Biotherapeutics, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib). BBT-877 BBT-877 200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
- Primary Outcome Measures
Name Time Method In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo After 24 weeks of treatment Change from baseline in FVC (in mL).
- Secondary Outcome Measures
Name Time Method In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo After 24 weeks of treatment Change from baseline in FVC (%).
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 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
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 Change from baseline compared to placebo in DLCO
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 Change in overall IPF symptoms as measured by the L-IPF total score from baseline
To assess the safety of BBT-877 compared to placebo over 24 weeks 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.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 Change from baseline in functional exercise capacity as measured by change in 6-minute walk distance assessed by the 6MWT
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 Pre-dose and 4 hr-post dose of plasma concentrations
To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF 0, 4, 12, 24 weeks of treatment Pre-dose and 4 hr-post dose of plasma concentrations.
Trial Locations
- Locations (44)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Institute for Respiratory Health
🇦🇺Nedlands, Western Australia, Australia
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Vitamed Galaj i Cichomski sp.j.
🇵🇱Bydgoszcz, Poland
Sheba Medical Center
🇮🇱Ramat Gan, Tel-Aviv, Israel
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Pulmonary Associates P.A.
🇺🇸Phoenix, Arizona, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
National Jewish Health Main Campus
🇺🇸Denver, Colorado, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Barzilai Medical Center
🇮🇱Petah Tikva, Israel
Central Florida Pulmonary Group PA
🇺🇸Orlando, Florida, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Premier Pulmonary Critical Care & Sleep Medicine
🇺🇸Denison, Texas, United States
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Kaplan Medical Center
🇮🇱Reẖovot, Israel
Soon Chun Hyang University Hospital Seoul
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
🇰🇷Yeongdeungpo-dong, Seoul, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Southern Arizona VA Health Care System - NAVREF - PPDS
🇺🇸Tucson, Arizona, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
St. Francis Medical Institute - Clinedge
🇺🇸Clearwater, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, 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
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
Tel Aviv Sourasky Medical Center
🇮🇱Ashkelon, HaDarom, Israel
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Rabin Medical Center
🇮🇱Petah tikva, Israel
The Catholic University of Korea, Bucheon St. Mary's Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Gangnam-gu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Namdong, Incheon, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnamdo, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seongbuk-gu, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of
Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz
🇵🇱Będzin, Slaskie, Poland
Severance Hospital Yonsei University
🇰🇷Seoul, Korea, Republic of