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Not yet recruiting NCT07730281

PRA-216 COPD Safety and Biomarker Study

Phase II Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRA-216, Placebo.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug PRA-216
    biologic
  • Drug Placebo
    matching placebo for PRA-216

Primary outcome measures

  • Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [Time frame: 40 weeks]
Secondary outcome measures (5)
  • 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: T1/2 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]

Eligibility criteria

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 2 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 drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism within 12 months prior to the first dose of study agent
  • History of severe allergic reactions or hypersensitivity
  • Receipt of immunosuppressant therapies for asthma within 3 months of screening
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07730281 · PRA-216-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗