Acute Respiratory Distress SyndromePhase 2NCT04565249

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

A Phase 2 study testing PLN-74809 in people with Acute Respiratory Distress Syndrome and SARS-CoV-2, run by Pliant Therapeutics, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Respiratory Distress Syndrome, SARS-CoV-2
What is being tested?: PLN-74809
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 6 sitesUnited States
Study dates: 22 Oct 2020to 2 Aug 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of ARDS (Berlin Criteria)
Hospitalized with at least severe COVID-19 (FDA 2020)
Receiving support for acute lung injury/respiratory distress via supplemental oxygen
Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine aminotransferase (ALT) concentration ≤ 150 U/L
Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis

Who cannot join

Greater than 72 hours since time of onset of ARDS.
Greater than 7 days since start of mechanical ventilation.
Currently receiving or anticipated to receive extracorporeal life support (ECLS), extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation
Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6 mL/kg of predicted body weight and prone positioning) and fluid management protocol (Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local institutional standards (HFOV).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Augusta University Medical Center
Augusta, Georgia, 30912
National Jewish Health
Denver, Colorado, 80206
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Advent Health
Orlando, Florida, 32803
Valleywise Health Medical Center
Phoenix, Arizona, 85008
Atlantic Health System
Summit, New Jersey, 07960

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a 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 (INTEGRIS-ARDS)

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

Read the detailed description

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).

In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD
In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD
In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD

Conditions: Acute Respiratory Distress Syndrome, SARS-CoV-2
Being tested: PLN-74809, Placebo
Medical subject headings: Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PLN-74809Drug
PLN-74809
PlaceboDrug
Placebo

Study groups in NCT04565249
Study group	Role	What they receive
PLN-74809 Dose Level1	Experimental	Dose Level 1 of PLN-74809 Receives: Drug: PLN-74809; Drug: Placebo
PLN-74809 Dose Level 2	Experimental	Dose Level 2 of PLN-74809 Receives: Drug: PLN-74809; Drug: Placebo
PLN74809 Dose Level 3	Experimental	Dose Level 3 of PLN-74809 Receives: Drug: PLN-74809; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 20202 Aug 2021

First posted25 Sep 2020
Study start22 Oct 2020
Primary completion1 Jun 2021
Study completion2 Aug 2021

Why it stopped: Study halted and will not resume; participants are no longer being examined or receiving intervention

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04565249
Sponsor's protocol ID: PLN-74809-ARDS-204
Status last verified: Sep 2020
First submitted: 15 Sep 2020
Last updated: 17 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a 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 (INTEGRIS-ARDS)
ClinicalTrials.gov ID: NCT04565249
Acronym / sponsor ID: PLN-74809-ARDS-204
Conditions: Acute Respiratory Distress Syndrome, SARS-CoV-2
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study halted and will not resume; participants are no longer being examined or receiving intervention
Enrolment: 6 participants (actual)
Lead sponsor: Pliant Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 22 Oct 2020 (actual)
Primary completion: 1 Jun 2021 (actual)
Study completion: 2 Aug 2021 (actual)
First posted: 25 Sep 2020 (actual)
Results: Posted 17 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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).

In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD
In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD
In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PLN-74809 Dose Level1	Experimental	Drug: PLN-74809, Drug: PlaceboDose Level 1 of PLN-74809
PLN-74809 Dose Level 2	Experimental	Drug: PLN-74809, Drug: PlaceboDose Level 2 of PLN-74809
PLN74809 Dose Level 3	Experimental	Drug: PLN-74809, Drug: PlaceboDose Level 3 of PLN-74809

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of ARDS (Berlin Criteria)
Hospitalized with at least severe COVID-19 (FDA 2020)
Receiving support for acute lung injury/respiratory distress via supplemental oxygen
Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine aminotransferase (ALT) concentration ≤ 150 U/L
Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis

Key exclusion criteria (4 listed)

Greater than 72 hours since time of onset of ARDS.
Greater than 7 days since start of mechanical ventilation.
Currently receiving or anticipated to receive extracorporeal life support (ECLS), extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation
Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6 mL/kg of predicted body weight and prone positioning) and fluid management protocol (Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local institutional standards (HFOV).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PLN-74809PLN-74809	Drug	PLN-74809 Dose Level 2, PLN-74809 Dose Level1, PLN74809 Dose Level 3
PlaceboPlacebo	Drug	PLN-74809 Dose Level 2, PLN-74809 Dose Level1, PLN74809 Dose Level 3

Primary outcome

Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0
Time frame: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit
Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities which was Assessed by CTCAE V5.

Results and safety

Results posted to the registry on 17 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PLN-74809: Dose 1 (40 mg)	5	5
PLN-74809: Dose 2 (80 mg)	0	0
PLN-74809: Dose 3 (160 mg)	0	0
Placebo	1	0

Primary outcome: Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0

Time frame: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit. Number. Unit: participants

Measure	PLN-74809: Dose Level 1 (40 mg) n = 5	PLN-74809: Dose Level 2 (80 mg) n = 0	PLN-74809: Dose Level 3 (160 mg) n = 0	Placebo n = 1
Value	0	–	–	0

Population analysed: 5 Participant received PLN-74809 and 1 participant received Placebo

Adverse events

Time frame: Adverse events were collected from the time the Informed Consent Form was completed until Day 28 study visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLN-74809: Dose Level 1 (40 mg)	3 of 5 (60%)	5 of 5 (100%)	0 of 5
PLN-74809: Dose Level 2 (80 mg)	0 of 0	0 of 0	0
PLN-74809: Dose Level 3 (160 mg)	0 of 0	0 of 0	0
Placebo	1 of 1 (100%)	1 of 1 (100%)	1 of 1

Limitations and caveats (from the sponsor): 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. As a result, the study did not reach the target number of participants needed to achieve target power and statistically reliable results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pliant Therapeutics study director

Pliant Therapeutics, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLN-74809 in people with Acute Respiratory Distress Syndrome and SARS-CoV-2, run by Pliant Therapeutics, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events and Laboratory Abnormalities, Assessed by CTCAE V5.0 (time frame: Adverse events were collected from the time the participant signed the Informed Consent Form until the Day 28 study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04565249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.