Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT07730281
PRA-216 COPD Safety and Biomarker Study
A Phase 2 study testing PRA-216 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Prana Therapies Inc at 5 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- PRA-216
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesAustralia
- Study dates
- 25 Aug 2026to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
University of the Sunshine Coast
Birtinya, Queensland, 4575
Peter de Wet, MBBS, FRACGP, (07) 5456 3549, pdewet@usc.edu.au
Alessandra Franceconi, MBBS FRACP
- Recruiting
Emeritus Research Sydney
Botany, New South Wales, 2019
Ronald Lok Yeung Mak, +61 (02) 8964 8186, sydneyinfo@emeritusresearch.com
Ronald Lok Yeung Mak, MBBS
- Recruiting
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Sewa Rijal, +61 (03) 9509 6166, info@emeritusresearch.com
Sewa Rijal, MD
- Not yet recruiting
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Nesiya Pallippattu Hassan, (02) 46342931, Nesiya.PallippattuHassan@health.nsw.gov.au
Shondell Tilden, (02) 46342931, Shondell.Tilden@health.nsw.gov.au
- Recruiting
Griffith University
Southport, Queensland, 4222
Hannah Smith, 0479178535, Hannah.smith@griffith.edu.au
Taryn Houghton, 0479178535, t.houghton@griffith.edu.au
About this study
Official title: 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
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of PRA-216, administered by SC injection in participants with moderate to severe COPD who are on standard of care treatment consisting of dual (ICS/LAMA or ICS/LABA) or triple inhaled maintenance therapy (ICS, LABA and LAMA).
The study will enroll approximately 40 participants at multiple study site and participants will be randomized 1:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.
- Being tested
- PRA-216, Placebo
- Keywords
- Inflammatory response, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRA-216Drug
biologic
PlaceboDrug
matching placebo for PRA-216
| Study group | Role | What they receive |
|---|---|---|
| Active PRA-216 | Active comparator | Participants with moderate to severe COPD will be randomized to receive PRA-216 Receives: Drug: PRA-216 |
| Placebo | Placebo comparator | Participants with moderate to severe COPD will be randomized to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe COPD
Measured: 40 weeks
Secondary outcomes (5)
The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants
FeNO is a non-invasive biomarker of airway inflammation in COPD. A higher number indicates higher inflammation. A reduction in FeNO levels might indicate functional activity of PRA-216.
Measured: 40 weeks
Pharmacokinetics of PRA-216: Tmax in patients with COPD
Time of maximum observed concentration of PRA-216 in plasma
Measured: 40 weeks
Pharmacokinetics of PRA-216: AUC in patients with COPD
Area under the curve of PRA-216 in plasma
Measured: 40 weeks
Pharmacokinetics of PRA-216: Cmax in patients with COPD
Maximum concentration of PRA-216 in plasma.
Measured: 40 weeks
Immunogenicity of PRA-216: ADA in patients with COPD
Incidence of anti-drug antibody following PRA-216 administration
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start25 Aug 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prana Therapies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730281
- Sponsor's protocol ID
- PRA-216-201
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07730281
- Acronym / sponsor ID
- PRA-216-201
- Keywords
- Inflammatory response, pharmacokinetics, pharmacodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prana Therapies IncIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of PRA-216, administered by SC injection in participants with moderate to severe COPD who are on standard of care treatment consisting of dual (ICS/LAMA or ICS/LABA) or triple inhaled maintenance therapy (ICS, LABA and LAMA).
The study will enroll approximately 40 participants at multiple study site and participants will be randomized 1:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PRA-216 | Active comparator | Drug: PRA-216Participants with moderate to severe COPD will be randomized to receive PRA-216 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with moderate to severe COPD will be randomized to receive placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRA-216biologic | Drug | Active PRA-216 |
| Placebomatching placebo for PRA-216 | Drug | Placebo |
Primary outcome
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 40 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe COPD
5 secondary outcomes
The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants
Time frame: 40 weeks
Pharmacokinetics of PRA-216: Tmax in patients with COPD
Time frame: 40 weeks
Pharmacokinetics of PRA-216: AUC in patients with COPD
Time frame: 40 weeks
Pharmacokinetics of PRA-216: Cmax in patients with COPD
Time frame: 40 weeks
Immunogenicity of PRA-216: ADA in patients with COPD
Time frame: 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRA-216 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Prana Therapies Inc at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.