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

Idiopathic Pulmonary Fibrosis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483907
• Other study ID #: BBT877-IPF-004
• Status: Recruiting
• Phase: Phase 2
• Start date: April 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Bridge Biotherapeutics, Inc.
• Contact: Bridge Biotherapeutics, Inc.
• Phone: +82-31-8092-3280
• Email: clinicaltrials.gov_inquiries[@]Bridgebiorx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• BBT-877
BBT-877 24 weeks + Follow-up 4 weeks
• Placebo
Placebo 24 weeks + Follow-up 4 weeks

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	Institute for Respiratory Health	Nedlands	Western Australia
Israel	Tel Aviv Sourasky Medical Center	Ashkelon	HaDarom
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Barzilai Medical Center	Petah Tikva
Israel	Rabin Medical Center	Petah tikva
Israel	Sheba Medical Center	Ramat Gan	Tel-Aviv
Israel	Kaplan Medical Center	Re?ovot
Korea, Republic of	The Catholic University of Korea, Bucheon St. Mary's Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Cheonan	Chungcheongnam-do
Korea, Republic of	Myongji Hospital	Goyang-si	Gyeonggido
Korea, Republic of	Gachon University Gil Medical Center	Namdong	Incheon
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Korea University Anam Hospital	Seoul	Seongbuk-gu
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu
Korea, Republic of	Severance Hospital Yonsei University	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo
Korea, Republic of	The Catholic University of Korea - Eunpyeong St. Mary's Hospital	Yeongdeungpo-dong	Seoul
Poland	Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz	Bedzin	Slaskie
Poland	Vitamed Galaj i Cichomski sp.j.	Bydgoszcz
United States	Augusta University	Augusta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Lung Research Center, LLC	Chesterfield	Missouri
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	St. Francis Medical Institute - Clinedge	Clearwater	Florida
United States	Premier Pulmonary Critical Care & Sleep Medicine	Denison	Texas
United States	National Jewish Health Main Campus	Denver	Colorado
United States	Hannibal Regional Healthcare System-HRMG-Hannibal	Hannibal	Missouri
United States	Medici Medical Research	Hollywood	Florida
United States	SoCal Clinical Research	Huntington Beach	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Renstar Medical Research	Ocala	Florida
United States	Central Florida Pulmonary Group PA	Orlando	Florida
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Bridge Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Israel,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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