A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of PRA-216 in Participants With Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
University of the Sunshine Coast
RECRUITING
Birtinya
Emeritus Research Sydney
RECRUITING
Botany
Emeritus Research Camberwell
RECRUITING
Camberwell
Campbelltown Hospital
NOT_YET_RECRUITING
Campbelltown
Griffith University
RECRUITING
Southport
Time Frame
Start Date: 2026-08-25
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Active PRA-216
Participants with moderate to severe COPD will be randomized to receive PRA-216
Placebo_comparator: Placebo
Participants with moderate to severe COPD will be randomized to receive placebo
Related Therapeutic Areas
Sponsors
Leads: Prana Therapies Inc