Trial Outcomes & Findings for Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809) (NCT NCT05621252)

Last Updated: 2025-12-05

Results Overview

Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	PLN-74809 PLN-74809: 160 mg PLN-74809	Placebo Placebo: Matching placebo
Overall Study STARTED	7	3
Overall Study COMPLETED	7	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PLN-74809 n=7 Participants 160 mg PLN-74809 PLN-74809: 160 mg PLN-74809	Placebo n=3 Participants Placebo Placebo: Matching placebo	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=37 Participants	0 Participants n=37 Participants	2 Participants n=74 Participants
Age, Categorical >=65 years	5 Participants n=37 Participants	3 Participants n=37 Participants	8 Participants n=74 Participants
Sex: Female, Male Female	1 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants
Sex: Female, Male Male	6 Participants n=37 Participants	3 Participants n=37 Participants	9 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=37 Participants	3 Participants n=37 Participants	10 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Asian	1 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) White	6 Participants n=37 Participants	3 Participants n=37 Participants	9 Participants n=74 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	PLN-74809 n=7 Participants PLN-74809: 160 mg PLN-74809	Placebo n=3 Participants Placebo: Matching placebo
Primary Outcome	-0.0147 Unitless Standard Deviation 0.10145	0.0740 Unitless Standard Deviation 0.11839

SECONDARY outcome

Timeframe: From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose

Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.

Outcome measures

Outcome measures
Measure	PLN-74809 n=7 Participants PLN-74809: 160 mg PLN-74809	Placebo n=3 Participants Placebo: Matching placebo
Secondary Safety and Tolerability	6 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Change from baseline in Forced vital capacity at 12 weeks.

Outcome measures

Outcome measures
Measure	PLN-74809 n=7 Participants PLN-74809: 160 mg PLN-74809	Placebo n=3 Participants Placebo: Matching placebo
Exploratory 1	21.4 mL Standard Deviation 86.49	-120.0 mL Standard Deviation 84.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Change from baseline in Cough Severity Visual Analog Scale at 12 weeks. Cough severity is assessed on a 100-mm linear scale ranging from "no cough" (0mm) to "worst cough" (100mm). Higher score means worse outcome.

Outcome measures

Outcome measures
Measure	PLN-74809 n=7 Participants PLN-74809: 160 mg PLN-74809	Placebo n=3 Participants Placebo: Matching placebo
Exploratory 2	-25.1 Mm Standard Deviation 29.11	40.3 Mm Standard Deviation 34.65

Adverse Events

PLN-74809

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pliant Therapeutics Medical Monitor

Pliant Therapeutics

Phone: 650-481-6770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	PLN-74809 n=7 participants at risk PLN-74809: 160 mg PLN-74809	Placebo n=3 participants at risk Placebo: Matching placebo
Respiratory, thoracic and mediastinal disorders Cough	57.1% 4/7 • Number of events 4 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	42.9% 3/7 • Number of events 3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Investigations Amylase increased	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/7 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Investigations Lipase increased	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 2 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/3 • Bexotegrast Group: 84.9 [2.04] days; Placebo Group: 84.7 [0.58] days Adverse Events: Safety population included all randomized participants who received at least 1 dose of study drug.