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

Phase 2

Active, not recruiting

• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Interventions: Drug: RLS-0071; Drug: Placebo

• Registration Number: NCT06175065
• Lead Sponsor: ReAlta Life Sciences, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Study Start: 2024-01-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RLS-0071	RLS-0071	Doses of RLS-0071, will be administered Q8H, three times a day, for at least 3 days and up to 5 days
Placebo	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to reach maximum observed serum concentration (Tmax) for RLS-0071	Day 1 and Day 3
Mortality rate of participants at 60 days after discharge	Day 1 to Day 60
Measure respiratory rate by measuring breaths per minute daily	Day 1 - Up to Day 5
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 from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.	Day 0 up to Day 5.
Number of participants rehospitalized for COPD up to Day 60	Day 1 to Day 60
Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.	Day 0 up to Day 5.
Measure the % O2 saturation via pulse oximetry daily	Day 1 - Up to Day 5
Maximum Observed Serum Concentration (Cmax) for RLS-0071	Day 1 and Day 3
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 participants that progressed to mechanical ventilation	Day 1 - Day 5
Measure heart rate via beats per minute daily	Day 1 - 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.
Number of days participant was hospitalized (length of stay).	Day 1 - Day 60

Trial Locations

Locations (4)

Site 02; 🇺🇸 Saint Petersburg, Florida, United States

Site 03; 🇺🇸 Glen Burnie, Maryland, United States

Site 04; 🇺🇸 Omaha, Nebraska, United States

Site 01; 🇺🇸 Philadelphia, Pennsylvania, United States