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

NCT ID: NCT06175065

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2025-06-30

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RLS-0071

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

Group Type: EXPERIMENTAL

RLS-0071

Intervention Type: DRUG

RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.

Interventions

RLS-0071

RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.

Intervention Type: DRUG

Placebo

Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReAlta Life Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 02

St. Petersburg, Florida, United States

Site 03

Glen Burnie, Maryland, United States

Site 04

Omaha, Nebraska, United States

Site 01

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

RLS-0071-204

Identifier Type: -

Identifier Source: org_study_id