Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: BBT-877
Pharmaceutical Form: Capsule
INN or Proposed INN: BBT-877
CAS Number: 2156655-68-2
Current Sponsor code: BBT-877
Other descriptive name: BBT-877
Concentration unit: mg milligram(
Sponsors
Bridge Biotherapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following are the main inclusion criteria: • Male patients who have completed family planning or female patient (of nonchildbearing potential or of childbearing potential with contraception), 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 available). 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 reports, 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 (>5000 feet [1524 meters] above sea level) 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 (based on FVC and functional impairment) 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 nor nintedanib. If the patients were on pirfenidone or nintedanib previously, they should have been off for at least 1 month prior to screening. For detail, please refer Section 4.1 Inclusion Criteria of Protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Unable to perform spirometry as per ATS (retest is allowed) • 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 (eg, human immunodeficiency virus infection, congenital, acquired, medication induced, organ transplantation) • Estimated life expectancy of less than 12 months (IPF related) or 30 months (for disease other than IPF) 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 (other than IPF) or other disease within 6 months prior to screening or during the screening period (eg, coronary heart disease, unstable angina, heart failure, stroke) • 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. For detail, please refer Section 4.2 Exclusion Criteria of Protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: • To evaluate the efficacy of BBT-877 in patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo after 24 weeks of treatment.;Secondary Objective: evaluate the efficacy ofBBT-877in patients with IPF by measuring the reduction in forced vital capacity(FVC)%predicted decline compared to placebo at Week24 of treatment evaluate the effect on diffusing capacity of lung for carbon monoxide(DLCO)ofBBT-877compared to placebo after24weeks of treatment evaluate the effect on functional exercise capacity(measured by the6-Minute Walk Test[6MWT])ofBBT-877 compared to placebo after24weeks of treatment assess the change in IPF symptoms and impacts from the patient perspective after 24weeks of treatment of BBT-877compared to placebo(St George’s Respiratory Questionnaire [SGRQ],Leicester Cough Questionnaire[LCQ],Living with Idiopathic Pulmonary Fibrosis Symptoms and Impact Questionnaire[L-IPF])after24weeks of treatment evaluate potential effect ofBBT-877on PK of each AF in patients with IPF evaluate potential effect of each AF on PK ofBBT-877 in patients with IPF assess the safety and tolerability of BBT-877 compared to placebo,over 24weeks;Primary end point(s): The primary endpoint is: • Change from baseline in FVC (in mL) compared to placebo at Week 24 stratified by presence/absence of background therapy (SoC) ;Timepoint(s) of evaluation of this end point: at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Change from baseline in FVC %predicted compared to placebo at Week 24 stratified by presence/absence of background therapy (SoC) • Change from baseline compared to placebo in DLCO at Week 24 • Change from baseline in functional exercise capacity as measured by change in 6-minute walk distance (6MWD) assessed by the 6MWT at Week 24, compared to placebo • Change in symptoms and impacts from the patient perspective from baseline at Week 24: o Overall Health ? Change in overall respiratory health as measured by the SGRQ total score from baseline to Week 24 (ie, symptoms, activities, and impacts) o Overall Symptoms ? Change in overall IPF symptoms as measured by the L-IPF Symptoms Questionnaire total score from baseline to Week 24 (ie, dyspnea, cough, energy) ? Change in IPF symptoms as measured by the “symptoms” subdomain score of the SGRQ from baseline to Week 24 o Specific Symptoms ? Change in shortness of breath as measured by the: • “Dyspnea/shortness of breath” subdomain score of the L-IPF Symptoms Questionnaire from baseline to Week 24 ? Change in physical symptoms of chronic cough as measured by: • The “physical” subdomain score of the LCQ from baseline to Week 24 • The “cough” subdomain score of the L-IPF Symptoms Questionnaire from baseline to Week 24 ? Change in physical energy as measured by the “energy” subdomain score of the L-IPF Symptoms Questionnaire from baseline to Week 24. o Overall Impacts ?Change in overall IPF impacts as measured by the LCQ total score from baseline to Week 24' ? Change in overall IPF impacts as measured by the L-IPF Impacts Questionnaire total score from baseline to Week 24 ? Change in IPF impacts as measured by the SGRQ “impacts” subdomain score from baseline to Week 24 o Specific Impacts ? Change in psychological impacts of chronic cough as measured by the “psychological” subdomain score of the LCQ from baseline to Week 24 ? Change in social impacts of chronic cough as meas | — |
Countries
Australia, Israel, Korea, Republic of, Poland, United States
Contacts
Public ContactClinical Trial Leader
Bridge Biotherapeutics, Inc.
Outcome results
None listed