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    Clinical Trial Results:
    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)

    Summary
    EudraCT number
    		 2022-001414-18
    Trial protocol
    		 PL  
    Global end of trial date
    20 Feb 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Nov 2025
    First version publication date
    09 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BBT877-IPF-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05483907
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bridge Biotherapeutics, Inc.
    Sponsor organisation address
    Suite 303, C’s tower 58, Pangyo-ro 255 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 13486
    Public contact
    Clinical Trial Leader, Bridge Biotherapeutics, Inc., +82 31-8092-3280, bbt877-ipf-004@bridgebiorx.com
    Scientific contact
    Clinical Trial Leader, Bridge Biotherapeutics, Inc., +82 31-8092-3280, bbt877-ipf-004@bridgebiorx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: • Consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and the Council for International Organizations of Medical Sciences International Ethical Guidelines. • Applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines. • Applicable laws and regulations Prior to starting participation in the study, each patient was provided with a study-specific ICF detailing the study treatments, procedures, and potential risks of the study. Patients or their legally authorized representative were required to sign a statement of informed consent that met the requirements of local regulations, ICH guidelines, and the IRB/EC or study site, where applicable. The patient was given a copy of the signed ICF, and the original was maintained with the patient’s records.
    Background therapy
    		 BBT-877 is used in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
    Evidence for comparator
    		 This study is placebo-controlled and placebo is used for comparator.
    Actual start date of recruitment
    23 Feb 2023
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Israel: 23
    Country: Number of subjects enrolled
    Korea, Republic of: 49
    Country: Number of subjects enrolled
    United States: 41
    Country: Number of subjects enrolled
    Poland: 3
    Worldwide total number of subjects
    129
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    17
    From 65 to 84 years
    110
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 226 patients were assessed for eligibility, and 129 eligible patients were randomly assigned to 1 of 2 treatment groups (64 patients to the BBT-877 group and 65 patients to the placebo group). All 129 patients were treated. The numbers of patients who completed study treatment were 57 in the BBT-877 group and 60 in the placebo group.

    Pre-assignment
    Screening details
    		 Screening period - up to 6 weeks before Baseline

    Period 1
    Period 1 title
    24-week treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BBT-877 200 mg
    Arm description
    		 Study arm: BBT-877 200 mg BID administered orally for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BBT-877
    Investigational medicinal product code
    Other name
    BBT-877 100 mg capsule
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules twice daily (BID), approximately 12 hours apart, taken with food (eg, meal,small meal, or a snack).

    Arm title
    		 Placebo
    Arm description
    		 Control arm: Placebo administered orally, for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules twice daily (BID), approximately 12 hours apart, taken with food (eg, meal, small meal, or a snack).

    Number of subjects in period 1
    		BBT-877 200 mg Placebo
    Started
    64
    65
    Completed
    57
    60
    Not completed
    7
    5
         Adverse event, serious fatal
    1
    -
         Withdrawal of Consent
    1
    2
         Adverse event, non-fatal
    4
    3
         Other
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BBT-877 200 mg
    Reporting group description
    		 Study arm: BBT-877 200 mg BID administered orally for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Control arm: Placebo administered orally, for 24 weeks.

    Reporting group values
    		 BBT-877 200 mg Placebo Total
    Number of subjects
    		 64 65 129
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 7 17
        From 65-84 years
    		 53 57 110
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        median (full range (min-max))
    		 71.0 (43 to 85) 71.0 (50 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 14 18 32
        Male
    		 50 47 97

    End points

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    End points reporting groups
    Reporting group title
    BBT-877 200 mg
    Reporting group description
    		 Study arm: BBT-877 200 mg BID administered orally for 24 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Control arm: Placebo administered orally, for 24 weeks.

    Primary: Change from baseline in FVC at Week 24 (in mL)

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    End point title
    		 Change from baseline in FVC at Week 24 (in mL)
    End point description
    Change from baseline in forced vital capacity FVC (in mL) compared to placebo at Week 24, stratified by the presence/absence of background therapy (standard of care [SoC])
    End point type
    Primary
    End point timeframe
    at Week 24
    End point values
    		 BBT-877 200 mg Placebo
    Number of subjects analysed
    64
    65
    Units: mL
    median (full range (min-max))
        Baseline
    2937.0 (1460 to 5114)
    2606.0 (1454 to 4673)
        Week 4
    3005.5 (1506 to 5134)
    2686.5 (1333 to 4686)
        Week 12
    2915.0 (1429 to 5009)
    2646.0 (1205 to 4674)
        Week 24
    2910.0 (1367 to 4869)
    2710.0 (1204 to 4616)
    Statistical analysis title
    		 Mixed-effects model with repeated measures - MMRM
    Comparison groups
    Placebo v BBT-877 200 mg
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.385
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in LS Means (vs. Placebo)
    Point estimate
    -25.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -73.7
         upper limit
    		 22.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs reported from the first dose of study treatment and through 30 days after the last dose of study treatment - 34 weeks.
    Adverse event reporting additional description
    BBT-877 was generally safe and well tolerated in patients with IPF, with or without AF background therapies.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    BBT-877 200 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 BBT-877 200 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 64 (7.81%)
    4 / 65 (6.15%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BBT-877 200 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 64 (75.00%)
    37 / 65 (56.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 64 (7.81%)
    3 / 65 (4.62%)
         occurrences all number
    5
    3
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    10 / 64 (15.63%)
    1 / 65 (1.54%)
         occurrences all number
    10
    1
    Nausea
         subjects affected / exposed
    7 / 64 (10.94%)
    1 / 65 (1.54%)
         occurrences all number
    7
    1
    Gastroesophageal reflux disease
         subjects affected / exposed
    0 / 64 (0.00%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 64 (1.56%)
    8 / 65 (12.31%)
         occurrences all number
    1
    8
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 64 (0.00%)
    4 / 65 (6.15%)
         occurrences all number
    0
    4
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 64 (10.94%)
    7 / 65 (10.77%)
         occurrences all number
    7
    7
    COVID-19
         subjects affected / exposed
    7 / 64 (10.94%)
    3 / 65 (4.62%)
         occurrences all number
    7
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 64 (4.69%)
    4 / 65 (6.15%)
         occurrences all number
    3
    4
    Bronchitis
         subjects affected / exposed
    4 / 64 (6.25%)
    1 / 65 (1.54%)
         occurrences all number
    4
    1
    Sinusitis
         subjects affected / exposed
    4 / 64 (6.25%)
    1 / 65 (1.54%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2023
    Protocol Version 7.0 dated 19 Oct 2023 • The randomization ratio of patients with AF and without AF-approved background therapies was removed, and the minimum number required for each group (with pirfenidone background therapy, with nintedanib background therapy, and without AF background therapy) was added. • The PK and PD analysis sets were updated to include patients who consented to participate in optional PK/PD part of the study after the first 20 patients were randomized from each group.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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