Clinical trial NCT05483907: To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Bridge Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 129
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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
* 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

Primary outcomes:
measure: In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
timeFrame: After 24 weeks of treatment
Secondary outcomes:
measure: In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo
timeFrame: After 24 weeks of treatment
measure: To evaluate the effect of on diffusing capacity of lung for carbon monoxide (DLCO) of BBT-877 compared to placebo
timeFrame: After 24 weeks of treatment
measure: To evaluate the effect on functional exercise capacity (measured by the 6-Minute Walk Test [6MWT]) of BBT-877 compared to placebo
timeFrame: After 24 weeks of treatment
measure: To assess the change in IPF impacts from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
timeFrame: after 24 weeks of treatment
measure: To assess the change in IPF symptoms from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
timeFrame: after 24 weeks of treatment
measure: To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF
timeFrame: 0, 4, 12, 24 weeks of treatment
measure: To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF
timeFrame: 0, 4, 12, 24 weeks of treatment
measure: To assess the safety of BBT-877 compared to placebo
timeFrame: over 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates P.A.
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System - NAVREF - PPDS
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Denver
country: United States
facility: National Jewish Health Main Campus
state: Colorado
city: Clearwater
country: United States
facility: St. Francis Medical Institute - Clinedge
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group PA
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Hannibal
country: United States
facility: Hannibal Regional Healthcare System-HRMG-Hannibal
state: Missouri
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Denison
country: United States
facility: Premier Pulmonary Critical Care & Sleep Medicine
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Nedlands
country: Australia
facility: Institute for Respiratory Health
state: Western Australia
city: Ashkelon
country: Israel
facility: Tel Aviv Sourasky Medical Center
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Petah Tikva
country: Israel
facility: Barzilai Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
state: Chungcheongnam-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggido
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
city: Namdong
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-gu
city: Yeongdeungpo-dong
country: Korea, Republic of
facility: The Catholic University of Korea - Eunpyeong St. Mary's Hospital
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University
city: Będzin
country: Poland
facility: Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz
state: Slaskie
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski sp.j.
Study officials:
References: