Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

May 7, 2025 updated by: ReAlta Life Sciences, Inc.

A Phase 2a Randomized, Doubled-Blind, Placebo-Controlled Trial to Evaluate Safety, Pharmacokinetics and Pharmacokinetic-Pharmacodynamic Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL). RLS-0071 is a novel peptide being developed for the treatment of AECOPD. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of adults with moderate exacerbations of COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo controlled trial in hospitalized participants with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of RLS-0071 compared to Placebo in the treatment of AECOPD. The dosing regimen will be 3 times a day for at least 3 days and up to 5 days total if still hospitalized. Participants will be followed for efficacy and safety for 30 and 60 days after the final dose. RLS-0071 or Placebo will be given as add-on therapy to SOC management for acute exacerbations of COPD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • Site 02
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Site 03
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Site 04
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Site 01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized participants with a prior diagnosis of COPD including spirometry within the prior year documenting a postbronchodilator FEV1/FVC ≤ 0.7 and an FEV1

    ≤ 80%, and a clinician identified admitting diagnosis of AECOPD: acute increase in dyspnea, sputum volume or purulence - without other attributable cause.

  • Participants must have a moderate exacerbation of COPD according to the Rome guidelines
  • ≥ 10 pack-years smoking history.

Exclusion Criteria:

  • Endotracheal intubation or mechanical ventilation.
  • Participants with severe exacerbation of COPD according to the Rome guidelines
  • Participants with signs and symptoms consistent with an alternative diagnosis for worsening of pulmonary status
  • Interstitial lung disease.
  • Current or prior history of asthma.
  • Known hypersensitivity, allergy, or reaction to polyethylene glycol (PEG)
  • Preexisting autoimmune disease: History of autoimmune disease and/or use of chronic steroids of >10mg/d (prednisone or equivalent) for more than 14 days prior to enrollment
  • Current renal dialysis or renal dialysis planned or anticipated in the next 7 days.

  • Has confounding medical conditions, including:

    1. diabetic coma,
    2. uncontrolled New York Heart Association Class IV congestive heart failure,
    3. uncontrolled angina,
    4. stroke or transient ischemic attack (TIA) within 4 weeks before study entry,
    5. clinically significant arrhythmias not controlled by medication, or
    6. idiopathic pulmonary fibrosis,
  • Has a weight >120 kg at Screening.
  • Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
  • Has systemic immunosuppression/immune deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RLS-0071
Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days
Drug: RLS-0071
RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.
Placebo Comparator: Placebo
Doses of Placebo for RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days
Drug: Placebo
Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 to Day 60
Day 1 to Day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to reach maximum observed serum concentration (Tmax) for RLS-0071
Time Frame: Day 1 and Day 3
Day 1 and Day 3
Maximum Observed Serum Concentration (Cmax) for RLS-0071
Time Frame: Day 1 and Day 3
Day 1 and Day 3
Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071
Time Frame: Day 1 and Day 3
Day 1 and Day 3
Terminal Phase Elimination Half-Life (t1/2) for RLS-0071
Time Frame: Day 1 and Day 3
Day 1 and Day 3
Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.
Time Frame: Day 0 up to Day 5.
Day 0 up to Day 5.
Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.
Time Frame: Day 0 up to Day 5.
Day 0 up to Day 5.
Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.
Time Frame: Day 0 up to Day 5.
Day 0 up to Day 5.
Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.
Time Frame: Day 0 up to Day 5.
Day 0 up to Day 5.
Number of days participant was hospitalized (length of stay).
Time Frame: Day 1 - Day 60
Day 1 - Day 60
Number of participants rehospitalized for COPD up to Day 60
Time Frame: Day 1 to Day 60
Day 1 to Day 60
Number of participants that progressed to mechanical ventilation
Time Frame: Day 1 - Day 5
Day 1 - Day 5
Mortality rate of participants at 60 days after discharge
Time Frame: Day 1 to Day 60
Day 1 to Day 60
Measure heart rate via beats per minute daily
Time Frame: Day 1 - Up to Day 5
Day 1 - Up to Day 5
Measure respiratory rate by measuring breaths per minute daily
Time Frame: Day 1 - Up to Day 5
Day 1 - Up to Day 5
Measure the % O2 saturation via pulse oximetry daily
Time Frame: Day 1 - Up to Day 5
Day 1 - Up to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ReAlta Life Sciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RLS-0071-204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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