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    Summary
    EudraCT Number:2022-001414-18
    Sponsor's Protocol Code Number:BBT877-IPF-004
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-12-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-001414-18
    A.3Full title of the trial
    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)
    A.4.1Sponsor's protocol code numberBBT877-IPF-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05483907
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBridge Biotherapeutics, Inc.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBridge Biotherapeutics, Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBridge Biotherapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Leader
    B.5.3 Address:
    B.5.3.1Street AddressSuite 303, C’s tower 58, Pangyo-ro 255 beon-gil, Bundang-gu Seongnam-si, Gyeonggi-do
    B.5.3.2Town/ citySeongnam-si
    B.5.3.3Post code13486
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+8231-8092-3280
    B.5.6E-mailkyungjin.kim@bridgebiorx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBBT-877
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBBT-877
    D.3.9.1CAS number 2156655-68-2
    D.3.9.2Current sponsor codeBBT-877
    D.3.9.3Other descriptive nameBBT-877
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    Idiopathic pulmonary fibrosis is a chronic irreversible and ultimately fatal disease characterized by a progressive decline in lung function
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 24
    E.5.2Secondary 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 measured by the “social” subdomain score of the LCQ from baseline to Week 24
    ▪ Change in impacts on activity as measured by the “activities” subdomain score of the SGRQ from baseline to Week 24 following SGRQ
    • Pharmacokinetic of BBT-877, pirfenidone and nintedanib (plasma concetrations at predose and approximately 4 hr postdose)
    • Incidence and severity of AEs including SAEs
    • Changes over time (baseline to Week 24) in:
    o Hematology, clinical chemistry, and urinalysis
    o 12-lead ECG parameters
    o Vital signs
    o Body weight
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Week 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Israel
    Korea, Republic of
    United States
    Poland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date of the last visit of the last
    patient in the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-02-20
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