Dose-Finding Study of Nemiralisib
Research type
Research Study
Full title
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)
IRAS ID
232772
Contact name
Elizabeth Sapey
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2017-001074-42
Duration of Study in the UK
1 years, 1 months, 17 days
Research summary
GlaxoSmithKline is conducting a study to evaluate the effectiveness and safety profile of different doses of Nemiralisib on lung function and in treating acute exacerbations of chronic obstructive pulmonary disease (COPD). Nemiralisib is a powder inhaled through the ELLIPTA™ inhaler. Information obtained from this study will be used to select the most effective and well tolerated dose of Nemiralisib for further studies. In addition, this study will further assess and confirm the pharmacokinetic [drug absorption, distribution, metabolism, and excretion] profile of Nemiralisib.
Nemiralisib is a phosphoinositide-3-kinase delta (PI3Kd) inhibitor that is being developed as an anti-inflammatory treatment (a treatment that reduces inflammation) for inflammatory airways (lung) diseases, like COPD.
This study will look at how people react to and how the body uses Nemiralisib at different doses added to their usual treatment (called standard of care [SoC]) compared to placebo (dummy drug) and SoC alone. Patients will either receive one of the 5 dose regimens of Nemiralisib or a placebo, in addition to SoC treatments for their COPD. Short-acting bronchodilators (albuterol/salbutamol) will not be allowed, unless given to the patient to use for treatment of acute exacerbation COPD during the study.
This study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week
Post-Treatment Follow-Up Period. Patients will visit the hospital 9 times (if Screening and Randomisation visit combined then 8 times) during the 24-week study period.All study treatments will be administered once-daily in the morning via the ELLIPTA
inhaler with the clip-on Propeller Sensor.Assessments include: Medical History, Chest X-Ray / CT Scan, physical exam, breathing tests, ECG, pregnancy test (if applicable), blood tests (including PK samples at specific sites), smoking cessation counselling and using an eDiary to complete several questionnaires.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0616
Date of REC Opinion
5 Dec 2017
REC opinion
Favourable Opinion