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

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ClinicalTrials.gov Identifier: NCT06097260
Recruitment Status : Recruiting
First Posted : October 24, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: PLN-74809 Drug: Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 16, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in absolute FVC (mL) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: Up to 52 weeks ]
    Time 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 52

  2. Change from baseline in absolute FVC (mL) at Week 52 [ Time Frame: 52 weeks ]
    • In participants on background therapy at baseline
    • In participants not on background therapy at baseline

  3. Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52 [ Time Frame: Up to 52 weeks ]
  4. Proportion of participants with treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 54 weeks ]
  5. Time to disease progression, defined as time to first occurrence of adjudicated respiratory-related hospitalization, adjudicated acute IPF exacerbation or all-cause mortality [ Time Frame: Up to 52 weeks ]
  6. Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score [ Time Frame: 52 Weeks ]
    The 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.

  7. Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score [ Time Frame: 52 Weeks ]
    The 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 status

  8. Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%) [ Time Frame: 52 Weeks ]
  9. To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment [ Time Frame: 52 Weeks ]
    Number of participants with Adverse Events (AEs) Number of participants with Serious AEs (SAEs)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 40 years of age prior to screening
  2. IPF diagnosis ≤ 7 years prior to screening
  3. FVCpp ≥ 45%
  4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and < 90%
  5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
  6. 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:

  1. Receiving pharmacologic therapy for pulmonary hypertension
  2. Self-reported smoking of any kind (not limited to tobacco)
  3. 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
  4. Hepatic impairment or end-stage liver disease
  5. Renal impairment or end-stage kidney disease requiring dialysis
  6. Pregnant or lactating female participant
  7. Uncontrolled systemic arterial hypertension
  8. Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
  9. Prior administration of bexotegrast
  10. Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
  11. Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 at screening
  12. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
  13. Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06097260


Contacts
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Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com

Locations
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Sponsors and Collaborators
Pliant Therapeutics, Inc.
Investigators
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Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
More Information
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Additional Information:

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Responsible Party: Pliant Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06097260    
Other Study ID Numbers: PLN-74809-IPF-206
BEACON-IPF ( Other Identifier: Pliant Therapeutics Inc )
First Posted: October 24, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pliant Therapeutics, Inc.:
IPF
idiopathic pulmonary fibrosis
pulmonary fibrosis
 bexotegrast
Beacon
BEACON-IPF
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases