A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed with an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) (study 200879)

A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed with an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) (study 200879) - 200879

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46452

Enrollment

Registered

2018-05-14

Start date

2018-01-29

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

Treatment with nemiralisib or placebo.

COPD

Exacerbation

GSK2269557

Nemiralisib

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Males and females 40 to 80 years of age. * Current or former cigarette smoker with a history of * 10 pack-years. * Acute exacerbation of COPD requiring an escalation in therapy to include oral or systemic corticosteroid(s) and antibiotic(s). See protocol pages 41-42 for details. * Body weight * 45 kg and BMI within the range 16 * 35 kg/m2 (inclusive). * Female participant of childbearing potential and male participant who agrees to follow the contraceptive guidance in appendix 5 of the protocol during the treatment period and for at least 60 hours after the last dose of study treatment.

Exclusion criteria

Exclusion criteria: * Asthma. * Acute respiratory acidosis, see protocol page 42 for details. * Moderate/severe exacerbation of COPD for which standard of care was started >48 hours since diagnosis. * Other clinically relevant lung diseases (other than COPD), see protocol page 43 for details. * Prior/Concomitant Therapies, see protocol page 44-45 for details. * History of regular alcohol consumption: Defined as an average weekly intake of >28 units for males or >21 units for females within 6 months. See protocol page 46 for details. * Prior/Concurrent Clinical Study Experience: see protocol page 45 for details. * Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Change from baseline in trough FEV1 at Day 84 measured post-bronchodilator.	—

Secondary

Measure	Time frame
COPD exacerbations over the 12 week treatment period. Time to next exacerbation. Trough FEV1 measured pre and post-bronchodilator at Days 14, 28, 56, and 84. Time to recovery from exacerbation. Severity of subsequent exacerbation(s). COPD Assessment Test (CAT). St. George*s Respiratory Questionnaire. Rescue medication use. PK parameters, adverse events..	—

Countries

Argentina, Australia, Canada, France, Germany, Italy, Korea (the Republic of), Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)