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

• ClinicalTrials.gov Identifier: NCT06097260
• Recruitment Status: Recruiting
• First Posted: October 24, 2023
• Last Update Posted: May 20, 2024
• Sponsor: Pliant Therapeutics, Inc.
• Information provided by (Responsible Party): Pliant Therapeutics, Inc.

Tracking Information

• First Submitted Date: October 18, 2023
• First Posted Date: October 24, 2023
• Last Update Posted Date: May 20, 2024
• Actual Study Start Date: November 16, 2023
• Estimated Primary Completion Date: August 31, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 18, 2023): Change from baseline in absolute FVC (mL) [ Time Frame: 52 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 24, 2024)

• 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
• 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
• Change from baseline in Living with Pulmonary Fibrosis (L-PF) total score at Week 52 [ Time Frame: Up to 52 weeks ]
• Proportion of participants with treatment-emergent adverse events and serious adverse events [ Time Frame: Up 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 mortality [ Time Frame: Up to 52 weeks ]
• 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.
• 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
• Absolute change from baseline in quantitative lung fibrosis (QLF) extent (%) [ Time Frame: 52 Weeks ]
• 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)

Original Secondary Outcome Measures (submitted: October 18, 2023)

• 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
• 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
• Change from baseline in Living with Pulmonary Fibrosis total score at Week 52 [ Time Frame: Up to 52 weeks ]
• Proportion of participants with treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 54 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
• 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)
• 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).

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: PLN-74809
  PLN-74809
• Drug: Placebo
  Placebo

Study Arms

• Experimental: Placebo
  Placebo
  Intervention: Drug: Placebo
• Experimental: Bexotegrast (PLN-74809) 160 mg Dose
  Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
  Intervention: Drug: PLN-74809
• Experimental: Bexotegrast (PLN-74809) 320 mg Dose
  Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks
  Intervention: Drug: PLN-74809

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 11, 2024): 360
• Original Estimated Enrollment (submitted: October 18, 2023): 267
• Estimated Study Completion Date: September 30, 2025
• Estimated Primary Completion Date: August 31, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Taiwan, United States
• Removed Location Countries: Austria

Administrative Information

• NCT Number: NCT06097260
• Other Study ID Numbers: PLN-74809-IPF-206; BEACON-IPF ( Other Identifier: Pliant Therapeutics Inc )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pliant Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pliant Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pliant Therapeutics Medical Monitor; Pliant Therapeutics, Inc.

• PRS Account: Pliant Therapeutics, Inc.
• Verification Date: April 2024