Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

PHASE2RECRUITING

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).

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Study details:

This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) \[160 and 320 mg\] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone). The study will consist of an up to 35-day Screening Period, a 52-week Treatment Period, and a 14 day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • ≥ 40 years of age prior to screening
  • IPF diagnosis ≤ 7 years prior to screening
  • FVCpp ≥ 45%
  • Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%
  • Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
  • If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening
  • Exclusion criteria

  • Receiving pharmacologic therapy for pulmonary hypertension
  • Self-reported smoking of any kind (not limited to tobacco)
  • History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
  • Hepatic impairment or end-stage liver disease
  • Renal impairment or end-stage kidney disease requiring dialysis
  • Pregnant or lactating female participant
  • Uncontrolled systemic arterial hypertension
  • Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
  • Prior administration of bexotegrast
  • Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
  • Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening
  • Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
  • Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
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    Eligibility

    Age eligible for study : 40 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-11-16

    Primary completion: 2025-08-31

    Study completion finish: 2025-09-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT06097260

    Intervention or treatment

    DRUG: PLN-74809

    DRUG: Placebo

    Conditions

    • Idiopathic Pulmonary Fibrosis

    Find a site

    Closest Location:

    The Alfred Hospital

    Research sites nearby

    Select from list below to view details:

    • The Alfred Hospital

      Melbourne, Victoria, Australia

    • Royal Prince Alfred Hospital

      Camperdown, New South Wales, Australia

    • Lung Research Qld

      Chermside, Queensland, Australia

    • Respiratory Clinical Trials

      Kent Town, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Placebo
    • Placebo
    DRUG: Placebo
    • Placebo
    EXPERIMENTAL: Bexotegrast (PLN-74809) 160 mg Dose
    • Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
    DRUG: PLN-74809
    • PLN-74809
    EXPERIMENTAL: Bexotegrast (PLN-74809) 320 mg Dose
    • Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
    DRUG: PLN-74809
    • PLN-74809

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change from baseline in absolute FVC (mL)Not Specified52 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Time to disease progressionTime to first occurrence of ≥10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), respiratory-related hospitalization, or all cause mortality through Week 52Up to 52 weeks
    Change from baseline in absolute FVC (mL) at Week 52* In participants on background therapy at baseline * In participants not on background therapy at baseline52 weeks
    Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52Not SpecifiedUp to 52 weeks
    Proportion of participants with treatment-emergent adverse events and serious adverse eventsNot SpecifiedUp to 54 weeks
    Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortalityNot SpecifiedUp to 52 weeks
    Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain scoreThe Living with Pulmonary Fibrosis (L-PF) questionnaire assesses symptoms and quality of life in patients with fibrosing interstitial lung diseases (ILDs). Its Dyspnoea and Cough domains, whose items' responses are based on a 24-hour recall, have scores ranging from 0 to 100, with higher scores indicating greater symptom severity. Domain and total scores range from 0 to 100, with higher scores indicating greater impairment.52 Weeks
    Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total scoreThe KBILD(King's Brief Interstitial Lung Disease Questionnaire) is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale.1 It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status52 Weeks
    Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%)Not Specified52 Weeks
    To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatmentNumber of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)52 Weeks

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    References

    Clinical Trials Gov: Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

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