PRA-216 COPD safety and biomarkers study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial evaluating PRA-216 given by subcutaneous injection in people with moderate to severe COPD on stable dual or triple inhaled therapy. Participants are randomized 1:1 to receive PRA-216 or placebo four times during the study. The study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity, with a focus on how the drug behaves in the body and its effects on inflammatory biomarkers. Approximately 40 participants will be enrolled across sites in Australia. The trial is sponsored by Prana Therapies Inc with collaboration across three research sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 40-80
* Willing and able to attend all study visits, comply with study requirements.
* Able and willing to provide written informed consent
* Documented COPD diagnosis prior for at least 12 months prior to screening.
* Currently receiving maintenance COPD medications at a stable dose for at least 3 months prior to visit 1

Exclusion Criteria:

* Evidence of clinically significant pulmonary condition or disease other than COPD
* Any physical or psychological condition that prohibits study completion
* Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Major surgery occurring within 8 weeks months prior to first dose of investigational product.
* Use of any marketed or investigational monoclonal or polyclonal antibody therapy within 4 months or 5 half-lives prior to visit 1.

Where it's running

• Emeritus Research Sydney
  Botany, New South Wales, Australia Recruiting
• University of the Sunshine Coast
  Birtinya, Queensland, Australia Recruiting
• Griffith University
  Southport, Queensland, Australia Recruiting
• Emeritus Research Camberwell
  Camberwell, Victoria, Australia Recruiting
• Campbelltown Hospital
  Campbelltown, New South Wales, Australia Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• IOS-based platform to screen, diagnose, and manage COPD and asthma

  This study tests an Impulse Oscillometry system to screen for and diagnose COPD and asthma and to help predict flare-ups over about a year, involving adults in China.

  Recruiting Beijing Chao Yang Hospital · Beijing, Beijing Municipality · NCT07910409

• Targeted NMES to improve breathing and leg/extra muscle strength in COPD

  This study tests whether targeted neuromuscular electrical stimulation helps people with COPD see improvements in breathing muscle function and overall muscle strength.

  Recruiting Universitas Padjadjaran · Bandung, West Java · NCT07910006

• AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer

  This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.

  Recruiting Phase 2 AeroRx Therapeutics Inc. · London and 1 other locations · NCT07896252

• PBMT with a pulmonary rehab program for COPD patients

  A small randomized trial tests whether adding photobiomodulation therapy before exercise in a COPD pulmonary rehab program helps improve functional capacity.

  Recruiting Federal University of Health Science of Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT07878884

• Controlled versus standard oxygen therapy for ICU COPD with acute exacerbation

  This trial tests whether keeping oxygen levels at 88-92% helps ICU patients with an acute COPD flare more than keeping levels above 94%.

  Recruiting Hôpital Universitaire Taher Sfar · Mahdia, Mahdia Governorate and 1 other locations · NCT07842510

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.