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

April 1, 2024 updated by: Bridge Biotherapeutics, Inc.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BBT-877
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
BBT-877 24 weeks + Follow-up 4 weeks
Placebo Comparator: Placebo
200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
Drug: Placebo
Placebo 24 weeks + Follow-up 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in FVC (in mL).
After 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo
Time Frame: After 24 weeks of treatment
Change from baseline in FVC (%).
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
Time Frame: After 24 weeks of treatment
Change from baseline compared to placebo in DLCO
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: after 24 weeks of treatment
Change in overall IPF symptoms as measured by the L-IPF total score from baseline
after 24 weeks of treatment
To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF
Time Frame: 0, 4, 12, 24 weeks of treatment
Pre-dose and 4 hr-post dose of plasma concentrations
0, 4, 12, 24 weeks of treatment
To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF
Time Frame: 0, 4, 12, 24 weeks of treatment
Pre-dose and 4 hr-post dose of plasma concentrations.
0, 4, 12, 24 weeks of treatment
To assess the safety of BBT-877 compared to placebo
Time Frame: 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.
over 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bridge Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBT877-IPF-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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