A Phase 2 interventional study of PLN-74809 and Placebo in Acute Respiratory Distress Syndrome and SARS-CoV-2, sponsored by Pliant Therapeutics, Inc.. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Pliant Therapeutics, Inc. · Phase 2, Interventional, and Treatment
Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio).
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Pliant Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose Level 1 of PLN-74809
Drug: PLN-74809 · Drug: Placebo
Dose Level 2 of PLN-74809
Drug: PLN-74809 · Drug: Placebo
Dose Level 3 of PLN-74809
Drug: PLN-74809 · Drug: Placebo
PLN-74809
Placebo
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.
Time frame: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit
The study was discontinued prior to completion of enrollment of Dose 1 due to the lack of participant availability following the introduction of COVID-19 vaccines as well as the increased and successful measures to contain the virus leading to a dramatic decrease in the number of severe and critical COVID-19 patients with ARDS.
| Milestone | PLN-74809: Dose 1 (40 mg) | PLN-74809: Dose 2 (80 mg) | PLN-74809: Dose 3 (160 mg) | Placebo |
|---|---|---|---|---|
| Started | 5 | 0 | 0 | 1 |
| Completed | 5 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 1 |
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.
| participants | PLN-74809: Dose Level 1 (40 mg) | PLN-74809: Dose Level 2 (80 mg) | PLN-74809: Dose Level 3 (160 mg) | Placebo |
|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0 | 0 | — | — | 0 |
Collected over Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PLN-74809: Dose Level 1 (40 mg) | 0/5 (0%) | 3/5 (60%) | 5/5 (100%) |
| PLN-74809: Dose Level 2 (80 mg) | — | — | — |
| PLN-74809: Dose Level 3 (160 mg) | — | — | — |
| Placebo | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Event | PLN-74809: Dose Level 1 (40 mg) | PLN-74809: Dose Level 2 (80 mg) | PLN-74809: Dose Level 3 (160 mg) | Placebo |
|---|---|---|---|---|
| Respiratory rate increasedInvestigations | 0/5 | — | — | 1/1 |
| Intestinal DilatationGastrointestinal disorders | 0/5 | — | — | 1/1 |
| Abdominal Compartment SyndromeGastrointestinal disorders | 0/5 | — | — | 1/1 |
| Ventricular TachycardiaCardiac disorders | 0/5 | — | — | 1/1 |
| Cardiac ArrestCardiac disorders | 0/5 | — | — | 1/1 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 2/5 | — | — | 0/1 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/5 | — | — | 0/1 |
| Event | PLN-74809: Dose Level 1 (40 mg) | PLN-74809: Dose Level 2 (80 mg) | PLN-74809: Dose Level 3 (160 mg) | Placebo |
|---|---|---|---|---|
| Lower Respiratory Tract InfectionInfections and infestations | 0/5 | — | — | 1/1 |
| Fluid OverloadMetabolism and nutrition disorders | 0/5 | — | — | 1/1 |
| Acute Kidney InjuryRenal and urinary disorders | 1/5 | — | — | 1/1 |
| Aspartate Aminotransferase IncreasedInvestigations | 2/5 | — | — | 0/1 |
| BradycardiaCardiac disorders | 1/5 | — | — | 0/1 |
| Cardiac AneurysmCardiac disorders | 1/5 | — | — | 0/1 |
| Coronary Artery DiseaseCardiac disorders | 1/5 | — | — | 0/1 |
| ConjunctivitisInfections and infestations | 1/5 | — | — | 0/1 |
| Urinary Tract InfectionInfections and infestations | 1/5 | — | — | 0/1 |
| Alanine Aminotransferase IncreasedInvestigations | 1/5 | — | — | 0/1 |
Study was discontinued before completion of enrollment of Dose 1.
| Age, Continuous(years) | PLN-74809: Dose 1 (40 mg) | PLN-74809: Dose 2 (80 mg) | PLN-74809: Dose 3 (160 mg) | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 57.4 ± 6.54 | — | — | 58.0 ± 0 | 57.5 ± 5.86 |
| Sex: Female, Male(Participants) | PLN-74809: Dose 1 (40 mg) | PLN-74809: Dose 2 (80 mg) | PLN-74809: Dose 3 (160 mg) | Placebo | Total |
|---|---|---|---|---|---|
| Female | 3 | — | — | 0 | 3 |
| Male | 2 | — | — | 1 | 3 |
| Race (NIH/OMB)(Participants) | PLN-74809: Dose 1 (40 mg) | PLN-74809: Dose 2 (80 mg) | PLN-74809: Dose 3 (160 mg) | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | 0 | 0 |
| Asian | 0 | — | — | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | 0 | 0 |
| Black or African American | 1 | — | — | 0 | 1 |
| White | 4 | — | — | 1 | 5 |
| More than one race | 0 | — | — | 0 | 0 |
| Unknown or Not Reported | 0 | — | — | 0 | 0 |
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Respiratory Distress Syndrome→
Pliant Therapeutics, Inc.