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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05483907
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bridge Biotherapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Israel, Korea, Republic of, Poland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Arms & Interventions

Arms

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).

Placebo Comparator: Placebo

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

Interventions

Drug: - BBT-877

BBT-877 24 weeks + Follow-up 4 weeks

Drug: - Placebo

Placebo 24 weeks + Follow-up 4 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pulmonary Associates P.A., Phoenix, Arizona

Status

Recruiting

Address

Pulmonary Associates P.A.

Phoenix, Arizona, 85006-2611

Site Contact

David Baratz, MD

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