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

NCT05483907 | Completed Phase 2 FDA Drug

• 1 other identifier: BBT877-IPF-004
• Study Type: interventional
• Target: 129
• Locations: 5 countries
• Sites: 44

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).

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo

  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

  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

  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

  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

  after 24 weeks of treatment

Study Arms (2)

BBT-877

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

Drug: Placebo

Interventions

BBT-877 DRUG

BBT-877 24 weeks + Follow-up 4 weeks

BBT-877

Placebo DRUG

Placebo 24 weeks + Follow-up 4 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bridge Biotherapeutics, Inc.: lead

Study Sites (44)

Pulmonary Associates P.A.

Phoenix, Arizona, 85006-2611, United States

Location

Southern Arizona VA Health Care System - NAVREF - PPDS

Tucson, Arizona, 85723-0001, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1207, United States

Location

National Jewish Health Main Campus

Denver, Colorado, 80206-2761, United States

Location

St. Francis Medical Institute - Clinedge

Clearwater, Florida, 33765, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Central Florida Pulmonary Group PA

Orlando, Florida, 32803-5443, United States

Location

Augusta University

Augusta, Georgia, 30912-0004, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611-2993, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153-3328, United States

Location

The Lung Research Center, LLC

Chesterfield, Missouri, 63017-3632, United States

Location

Hannibal Regional Healthcare System-HRMG-Hannibal

Hannibal, Missouri, 63401-6890, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-8900, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

Premier Pulmonary Critical Care & Sleep Medicine

Denison, Texas, 75020, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4006, Australia

Location

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

Location

Meir Medical Center

Kfar Saba, Central District, 44281, Israel

Location

Lady Davis Carmel Medical Center

Haifa, Haifa District, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, Jerusalem, 91120, Israel

Location

Tel Aviv Sourasky Medical Center

Ashkelon, Southern District, 78278, Israel

Location

Sheba Medical Center

Ramat Gan, Tel Aviv, 52621, Israel

Location

Barzilai Medical Center

Petah Tikva, 4910000, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz

Będzin, Silesian Voivodeship, 42-500, Poland

Location

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, 85-681, Poland

Location

Soon Chun Hyang University Hospital Seoul

Cheonan, Chungcheongnam-do, 31151, South Korea

Location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13497, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Myongji Hospital

Goyang-si, Gyeonggido, 10475, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Gachon University Gil Medical Center

Namdong, Incheon, 21565, South Korea

Location

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

The Catholic University of Korea - Eunpyeong St. Mary's Hospital

Yeongdeungpo-dong, Seoul, 07345, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Severance Hospital Yonsei University

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40404183 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

ATX inhibitor BBT-877

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 2, 2022
• Study Start: April 12, 2023
• Primary Completion: January 26, 2025
• Study Completion: February 23, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

AU (3); IL (8); PL (2); US (16); KR (15)