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

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175065
• Other study ID #: RLS-0071-204
• Status: Recruiting
• Phase: Phase 2
• Start date: January 25, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: ReAlta Life Sciences, Inc.
• Contact: Claire Whitaker
• Phone: 757-901-0322
• Email: cwhitaker[@]realtals.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• RLS-0071
RLS-0071, will be administered as an IV infusion 10 mg/kg. Planned infusion duration is 8 minutes.
• Placebo
Placebo control (commercial sterile saline), will be administered as an IV infusion. Planned infusion duration is 8 minutes.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ReAlta Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)		Day 1 to Day 60
Secondary	Time to reach maximum observed serum concentration (Tmax) for RLS-0071		Day 1 and Day 3
Secondary	Maximum Observed Serum Concentration (Cmax) for RLS-0071		Day 1 and Day 3
Secondary	Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071		Day 1 and Day 3
Secondary	Terminal Phase Elimination Half-Life (t1/2) for RLS-0071		Day 1 and Day 3
Secondary	Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.		Day 0 up to Day 5.
Secondary	Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.		Day 0 up to Day 5.
Secondary	Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.		Day 0 up to Day 5.
Secondary	Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.		Day 0 up to Day 5.
Secondary	Number of days participant was hospitalized (length of stay).		Day 1 - Day 60
Secondary	Number of participants rehospitalized for COPD up to Day 60		Day 1 to Day 60
Secondary	Number of participants that progressed to mechanical ventilation		Day 1 - Day 5
Secondary	Mortality rate of participants at 60 days after discharge		Day 1 to Day 60
Secondary	Measure heart rate via beats per minute daily		Day 1 - Up to Day 5
Secondary	Measure respiratory rate by measuring breaths per minute daily		Day 1 - Up to Day 5
Secondary	Measure the % O2 saturation via pulse oximetry daily		Day 1 - Up to Day 5