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

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: Recruiting
• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: RLS-0071; Drug: Placebo

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: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Claire Whitaker; Phone Number: 757-901-0322; Email: cwhitaker@realtals.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Recruiting
      • Temple University
      • Contact: Gerald Criner, MD; Phone Number: 215-707-1359; Email: breathe@tuhs.temple.edu
      • Principal Investigator: Gerald Criner, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	Day 1 to Day 60

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to reach maximum observed serum concentration (Tmax) for RLS-0071	Day 1 and Day 3
Maximum Observed Serum Concentration (Cmax) for RLS-0071	Day 1 and Day 3
Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071	Day 1 and Day 3
Terminal Phase Elimination Half-Life (t1/2) for RLS-0071	Day 1 and Day 3
Evaluate the change in plasma neutrophil counts from 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.	Day 0 up to Day 5.
Evaluate the change from baseline in erythrocyte sedimentation rate from 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.	Day 0 up to Day 5.
Number of days participant was hospitalized (length of stay).	Day 1 - Day 60
Number of participants rehospitalized for COPD up to Day 60	Day 1 to Day 60
Number of participants that progressed to mechanical ventilation	Day 1 - Day 5
Mortality rate of participants at 60 days after discharge	Day 1 to Day 60
Measure heart rate via beats per minute daily	Day 1 - Up to Day 5
Measure respiratory rate by measuring breaths per minute daily	Day 1 - Up to Day 5
Measure the % O2 saturation via pulse oximetry daily	Day 1 - Up to Day 5

Collaborators and Investigators

• Sponsor: ReAlta Life Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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