PRA-216 COPD Safety and Biomarker Study

NCT07730281 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PRA-216-201
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Inflammatory response; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• 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

  40 weeks

Secondary Outcomes (5)

• The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants

  40 weeks

• Pharmacokinetics of PRA-216: T1/2 in patients with COPD

  40 weeks

• Pharmacokinetics of PRA-216: AUC in patients with COPD

  40 weeks

• Pharmacokinetics of PRA-216: Cmax in patients with COPD

  40 weeks

• Immunogenicity of PRA-216: ADA in patients with COPD

  40 weeks

Study Arms (2)

Active PRA-216

ACTIVE COMPARATOR

Participants with moderate to severe COPD will be randomized to receive PRA-216

Drug: PRA-216

Placebo

PLACEBO COMPARATOR

Participants with moderate to severe COPD will be randomized to receive placebo

Drug: Placebo

Interventions

PRA-216 DRUG

biologic

Active PRA-216

Placebo DRUG

matching placebo for PRA-216

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prana Therapies Inc: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07