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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: BBT-877
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |