Trial Outcomes & Findings for Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/ (NCT NCT04072315)
NCT ID: NCT04072315
Last Updated: 2023-12-12
Results Overview
Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Following 1 day of dosing
Results posted on
2023-12-12
Participant Flow
The first participant on this study was enrolled in February 2020 and the last participant in May 2022. The enrollment period was prolonged due to the limited clinical trial operations at the research site, caused by COVID-19 pandemic.
Participant milestones
| Measure |
60 mg
PLN-74809: PLN-74809 (60 mg)
Knottin tracer: Radiotracer
|
120 mg and 240 mg
PLN-74809: PLN-74809 (120 mg and 240 mg)
Knottin tracer: Radiotracer
|
320 mg
PLN-74809: PLN-74809 (320 mg)
Knottin tracer: Radiotracer
|
240 mg and 320 mg
PLN-74809: PLN-74809 (240 mg and 320 mg)
Knottin tracer: Radiotracer
|
320 mg and 120 mg
PLN-74809: PLN-74809 (320 mg and 120 mg)
Knottin tracer: Radiotracer
|
80 mg and 240 mg
PLN-74809: PLN-74809 (80 mg and 240 mg)
|
80 mg and 120 mg
PLN-74809: PLN-74809 (80 mg and 120 mg)
|
120 mg and 320 mg
PLN-74809: PLN-74809 (120 mg and 320 mg)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Baseline characteristics by cohort
| Measure |
60 mg
n=1 Participants
PLN-74809: PLN-74809 (60 mg)
|
120 mg and 240 mg
n=1 Participants
PLN-74809: PLN-74809 (120 mg and 240 mg)
|
320 mg
n=1 Participants
PLN-74809: PLN-74809 (320 mg)
|
240 mg and 320 mg
n=2 Participants
PLN-74809: PLN-74809 (240 mg and 320 mg)
|
320 mg and 120 mg
n=1 Participants
PLN-74809: PLN-74809 (320 mg and120 mg)
|
80 mg and 240 mg
n=1 Participants
PLN-74809: PLN-74809 (80 mg and 240 mg)
|
80 mg and 120 mg
n=1 Participants
PLN-74809: PLN-74809 (80 mg and 120 mg)
|
120 mg and 320 mg
n=1 Participants
PLN-74809: PLN-74809 (120 mg and 320 mg)
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
|
Age, Continuous
|
77 Years
STANDARD_DEVIATION 0 • n=99 Participants
|
69 Years
STANDARD_DEVIATION 0 • n=107 Participants
|
76 Years
STANDARD_DEVIATION 0 • n=206 Participants
|
83.5 Years
STANDARD_DEVIATION .71 • n=157 Participants
|
77 Years
STANDARD_DEVIATION 0 • n=390 Participants
|
76 Years
STANDARD_DEVIATION 0 • n=16 Participants
|
77 Years
STANDARD_DEVIATION 0 • n=3 Participants
|
79 Years
STANDARD_DEVIATION 0 • n=6 Participants
|
77.6 Years
STANDARD_DEVIATION 4.36 • n=114 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Following 1 day of dosingAssessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.
Outcome measures
| Measure |
240 mg and 320 mg
n=2 Participants
PLN-74809: PLN-74809 (240 mg and 320 mg)
Knottin tracer: Radiotracer
|
320 mg and 120 mg
n=1 Participants
PLN-74809: PLN-74809 (320 mg and 120 mg)
Knottin tracer: Radiotracer
|
80 mg and 240 mg
n=1 Participants
PLN-74809: PLN-74809 (80 mg and 240 mg)
Knottin tracer: Radiotracer
|
80 mg and 120 mg
n=1 Participants
PLN-74809: PLN-74809 (80 mg and 120 mg)
Knottin tracer: Radiotracer
|
120 mg and 320 mg
n=1 Participants
PLN-74809: PLN-74809 (120 mg and 320 mg)
Knottin tracer: Radiotracer
|
60 mg
n=1 Participants
PLN-74809: PLN-74809 (60 mg)
|
120 mg and 240 mg
n=1 Participants
PLN-74809: PLN-74809 (120 mg and 240 mg)
|
320 mg
n=1 Participants
PLN-74809: PLN-74809 (320 mg)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening to 1 week following the administration of PLN-74809Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14).
Outcome measures
| Measure |
240 mg and 320 mg
n=2 Participants
PLN-74809: PLN-74809 (240 mg and 320 mg)
Knottin tracer: Radiotracer
|
320 mg and 120 mg
n=1 Participants
PLN-74809: PLN-74809 (320 mg and 120 mg)
Knottin tracer: Radiotracer
|
80 mg and 240 mg
n=1 Participants
PLN-74809: PLN-74809 (80 mg and 240 mg)
Knottin tracer: Radiotracer
|
80 mg and 120 mg
n=1 Participants
PLN-74809: PLN-74809 (80 mg and 120 mg)
Knottin tracer: Radiotracer
|
120 mg and 320 mg
n=1 Participants
PLN-74809: PLN-74809 (120 mg and 320 mg)
Knottin tracer: Radiotracer
|
60 mg
n=1 Participants
PLN-74809: PLN-74809 (60 mg)
|
120 mg and 240 mg
n=1 Participants
PLN-74809: PLN-74809 (120 mg and 240 mg)
|
320 mg
n=1 Participants
PLN-74809: PLN-74809 (320 mg)
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
60 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
120 mg and 240 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
320 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
240 mg and 320 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
320 mg and 120 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
80 mg and 240 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
80 mg and 120 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
120 mg and 320 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
60 mg
n=1 participants at risk
PLN-74809 (60 mg)
|
120 mg and 240 mg
n=1 participants at risk
PLN-74809 (120 mg and 240 mg)
|
320 mg
n=1 participants at risk
PLN-74809 (320 mg)
|
240 mg and 320 mg
n=2 participants at risk
PLN-74809 (240 mg and 320 mg)
|
320 mg and 120 mg
n=1 participants at risk
PLN-74809 (320 mg and 120 mg)
|
80 mg and 240 mg
n=1 participants at risk
PLN-74809 (80 mg and 240 mg)
|
80 mg and 120 mg
n=1 participants at risk
PLN-74809 (80 mg and 120 mg)
|
120 mg and 320 mg
n=1 participants at risk
PLN-74809 (120 mg and 320 mg)
|
|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Gamma-glutamyltransferase increased
|
0.00%
0/1 • 15 Days
|
0.00%
0/1 • 15 Days
|
100.0%
1/1 • Number of events 1 • 15 Days
|
0.00%
0/2 • 15 Days
|
0.00%
0/1 • 15 Days
|
0.00%
0/1 • 15 Days
|
0.00%
0/1 • 15 Days
|
0.00%
0/1 • 15 Days
|
|
Hepatobiliary disorders
Hepatic Enzyme Increased
|
0.00%
0/1 • 15 Days
|
0.00%
0/1 • 15 Days
|
100.0%
1/1 • Number of events 1 • 15 Days
|
0.00%
0/2 • 15 Days
|
0.00%
0/1 • 15 Days
|
100.0%
1/1 • Number of events 1 • 15 Days
|
0.00%
0/1 • 15 Days
|
0.00%
0/1 • 15 Days
|
Additional Information
Éric Lefebvre, M.D., Chief Medical Officer
Pliant Therapeutics, Inc.
Phone: 1-650-481-6779
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place