Clinical trial NCT06175065: Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead sponsor: ReAlta Life Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 to Day 60
Secondary outcomes:
measure: Time to reach maximum observed serum concentration (Tmax) for RLS-0071
timeFrame: Day 1 and Day 3
measure: Maximum Observed Serum Concentration (Cmax) for RLS-0071
timeFrame: Day 1 and Day 3
measure: Area Under the Curve From Time 0 to Infinity (AUC [0 - infinity]) for RLS-0071
timeFrame: Day 1 and Day 3
measure: Terminal Phase Elimination Half-Life (t1/2) for RLS-0071
timeFrame: Day 1 and Day 3
measure: Evaluate the change in plasma neutrophil counts from Day 0 up to Day 5.
timeFrame: Day 0 up to Day 5.
measure: Evaluate the change from baseline in eosinophil counts from Day 0 up to Day 5.
timeFrame: Day 0 up to Day 5.
measure: Evaluate the change from baseline in erythrocyte sedimentation rate from Day 0 up to Day 5.
timeFrame: Day 0 up to Day 5.
measure: Evaluate the change in baseline in c-reactive protein in blood from Day 0 up to Day 5.
timeFrame: Day 0 up to Day 5.
measure: Number of days participant was hospitalized (length of stay).
timeFrame: Day 1 - Day 60
measure: Number of participants rehospitalized for COPD up to Day 60
timeFrame: Day 1 to Day 60
measure: Number of participants that progressed to mechanical ventilation
timeFrame: Day 1 - Day 5
measure: Mortality rate of participants at 60 days after discharge
timeFrame: Day 1 to Day 60
measure: Measure heart rate via beats per minute daily
timeFrame: Day 1 - Up to Day 5
measure: Measure respiratory rate by measuring breaths per minute daily
timeFrame: Day 1 - Up to Day 5
measure: Measure the % O2 saturation via pulse oximetry daily
timeFrame: Day 1 - Up to Day 5
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Site 02
state: Florida
city: Glen Burnie
country: United States
facility: Site 03
state: Maryland
city: Omaha
country: United States
facility: Site 04
state: Nebraska
city: Philadelphia
country: United States
facility: Site 01
state: Pennsylvania
Study officials:
References: