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Idiopathic Pulmonary FibrosisPhase 2NCT05483907

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

A Phase 2 study testing BBT-877 in people with Idiopathic Pulmonary Fibrosis, run by Bridge Biotherapeutics, Inc. at 44 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BBT-877
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
44 sitesin 5 countries
Study dates
12 Apr 2023to 23 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

44 sites in 5 countries.

44 sites in 5 countries

United States16 sites

  • Augusta University

    Augusta, Georgia, 30912-0004

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-8900

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017-3632

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611-2993

  • St. Francis Medical Institute - Clinedge

    Clearwater, Florida, 33765

  • Premier Pulmonary Critical Care & Sleep Medicine

    Denison, Texas, 75020

  • National Jewish Health Main Campus

    Denver, Colorado, 80206-2761

  • Hannibal Regional Healthcare System-HRMG-Hannibal

    Hannibal, Missouri, 63401-6890

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • Loyola University Medical Center

    Maywood, Illinois, 60153-3328

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Central Florida Pulmonary Group PA

    Orlando, Florida, 32803-5443

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1207

  • Pulmonary Associates P.A.

    Phoenix, Arizona, 85006-2611

  • Southern Arizona VA Health Care System - NAVREF - PPDS

    Tucson, Arizona, 85723-0001

Other trials in United States

South Korea15 sites

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

    Bucheon-si, Gyeonggi-do, 14647

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Soon Chun Hyang University Hospital Seoul

    Cheonan, Chungcheongnam-do, 31151

  • Myongji Hospital

    Goyang-si, Gyeonggido, 10475

  • Gachon University Gil Medical Center

    Namdong, Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13497

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

  • Korea University Anam Hospital

    Seoul, Seongbuk-gu, 02841

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

  • Kyung Hee University Hospital

    Seoul, 02447

  • Severance Hospital Yonsei University

    Seoul, 03722

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

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

    Yeongdeungpo-dong, Seoul, 07345

Other trials in South Korea

Israel8 sites

  • Tel Aviv Sourasky Medical Center

    Ashkelon, Southern District, 78278

  • Lady Davis Carmel Medical Center

    Haifa, Haifa District, 34362

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, Central District, 44281

  • Barzilai Medical Center

    Petah Tikva, 4910000

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Australia3 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4006

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

Other trials in Australia

Poland2 sites

  • Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz

    Będzin, Silesian Voivodeship, 42-500

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, 85-681

Other trials in Poland

About this study

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)

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).

Being tested
BBT-877, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBT-877Drug

    BBT-877 24 weeks + Follow-up 4 weeks

  • PlaceboDrug

    Placebo 24 weeks + Follow-up 4 weeks

Study groups in NCT05483907
Study groupRoleWhat they receive
BBT-877Experimental200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
Receives: Drug: BBT-877
PlaceboPlacebo comparator200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: After 24 weeks of treatment

Secondary outcomes (8)

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

    Change from baseline in FVC (%).

    Measured: After 24 weeks of treatment

  2. 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

    Measured: After 24 weeks of treatment

  3. 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

    Measured: After 24 weeks of treatment

  4. 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

    Measured: after 24 weeks of treatment

  5. 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

    Measured: after 24 weeks of treatment

  6. 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

    Measured: 0, 4, 12, 24 weeks of treatment

  7. 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.

    Measured: 0, 4, 12, 24 weeks of treatment

  8. 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.

    Measured: over 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start12 Apr 2023
  3. Primary completion26 Jan 2025
  4. Study completion23 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483907
Sponsor's protocol ID
BBT877-IPF-004
Status last verified
Mar 2025
First submitted
27 Jul 2022
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40404183

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BBT-877 in people with Idiopathic Pulmonary Fibrosis, run by Bridge Biotherapeutics, Inc. at 44 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, South Korea, Israel, Australia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo (time frame: After 24 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05483907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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