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

TerminatedPhase 2

Sponsor: Pliant Therapeutics, Inc.

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: PLN-74809, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China

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).

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (268)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
New Port Beach, California, United States
Palm Springs, California, United States
Palo Alto, California, United States
Redding, California, United States
Sacramento, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Danbury, Connecticut, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Leesburg, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Indianapolis, Indiana, United States
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