Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma
NCT ID: NCT03207243
Last Updated: 2020-03-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2017-09-14
2019-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy.
NCT00603746
A 12-Week Study in Adult Subjects With Asthma
NCT01516086
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.
NCT00603278
12-Week Study in Adult Subjects With Asthma
NCT01516073
Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)
NCT03393806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subjects receiving GSK3772847
Eligible subjects will receive GSK3772847 once every 4 weeks via IV route along with 500/50 mcg FP/Sal twice daily for first 2 weeks and dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation.
GSK3772847
GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.
Fluticasone propionate/salmeterol
FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
Fluticasone propionate
FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.
Subjects receiving placebo drug
Eligible subjects will receive placebo once every 4 weeks via IV route along with 500/50 mcg FP/Sal twice daily for first 2 weeks and dose of FP was reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation.
Placebo
Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.
Fluticasone propionate/salmeterol
FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
Fluticasone propionate
FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GSK3772847
GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.
Placebo
Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.
Fluticasone propionate/salmeterol
FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
Fluticasone propionate
FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Males and females: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow highly effective contraceptive methods from 4 weeks prior to the first dose of study medication and until at least 16 weeks after the last dose of study medication and completion of the follow-up visit.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
* A subject with a documented diagnosis of moderate severe asthma based on Global Initiative for Asthma (GINA) 2016 Guidelines, whose asthma has been managed with regular treatment of high dose ICS defined as FP 500 mcg twice daily (i.e. 1000 mcg total daily dose) or equivalent, and LABA for at least 4 months. Additional therapy with a leukotriene receptor antagonist (LTRA) is permissible.
* Airway reversibility of at least 12 percent and 200 milliliter (mL) in FEV1 at Screening (Visit 1), or documented reversibility prior to Screening (Visit 1), or documented history of bronchial hyper reactivity (e.g. fall in FEV1 from baseline of more than or equal to 20percent with standard doses of methacholine or histamine, or more than or equal to 15 percent with standardized hyperventilation, hypertonic saline or mannitol challenge) from a bronchoprovocation study \[e.g. methacholine challenge prior to Screening (Visit 1)\].
* ACQ-5 score more than or equal to 1.0 and less than 4.0 at Screening (Visit 1).
* Had at least one asthma exacerbation within 12 months prior to screening that required treatment with systemic corticosteroid and/or hospitalization.
* All subjects must be able to replace their current Short-Acting Beta2-Agonists (SABA) treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, per product label, for the duration of the study.
* ACQ-5 score more than or equal to 1.0 and less than 4.0 at Visit 2.
* Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on more than or equal to 4 of the last 7 days during the run-in period.
Exclusion Criteria
* Presence of a known pre-existing, clinically important respiratory conditions (e.g. pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma.
* A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Screening (Visit 1).
* Subjects with a diagnosis of malignancy or in the process of investigation for a malignancy. Subjects with carcinoma that have not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment.
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at Screening (Visit 1) or within 3 months prior to first dose of study treatment.
* Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of subject eligibility.
* Weight: less than 50 kilograms (kg) and more than 150 kg.
* Regular use of systemic corticosteroids for conditions including asthma within 3 months prior to Screening (Visit 1).
* Subjects with high parasympathetic tone (e.g. trained athletes with baseline bradycardia) or chronic conditions associated with parasympathetic surges (e.g. migraines).
* Other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1).
* Clinically significant organic heart disease \[e.g. Coronary artery disease (CAD), New York Heart Association (NYHA) Class III/IV heart failure\].
* Ongoing infections (i.e. not resolved within 7 days prior to Screening \[Visit 1\]) or recurrent infections (i.e. requiring treatment for an identical diagnosis within 3 months) requiring systemic antibiotics Known, pre-existing parasitic infestations within 6 months prior to Screening.
* A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
* A known immunodeficiency such as human immunodeficiency virus infection.
* Subjects with allergy or intolerance to a monoclonal antibody or biologic or to any components of the formulation used in this study.
* Subjects with a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Screening (Visit 1).
* Subjects who are unable to follow study instructions such as visit schedule, dosing directions, study eDiary completion, or use of a standard metered dose inhaler. Subjects who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
* Subjects who have previously participated in a study of GSK3772847.
* Use of the prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study. Potential subjects should not be washed out of their medication solely for the purpose on enrolling in the trial.
* A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator.
* In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a diary card/questionnaire.
* Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
* Evidence of clinically significant abnormal laboratory tests during screening which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
* Evidence of clinically significant abnormal ECG findings at Visit 2.
* An abnormal and significant finding from 24-hour Holter monitoring at Screening (Visit 1). Investigators will be provided with Holter reviews conducted by an independent cardiologist to assist in evaluation of subject eligibility.
* Liver function at screening (Visit 1): ALT more than 2 x upper limit of normal (ULN) and bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percent); Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Subjects with ongoing asthma exacerbation at the time of Visit 2.
* A pre-bronchodilator FEV1 less than 50 percent predicted of normal value at Visit 2.
* Positive pregnancy test at Visit 0, Screening (Visit 1) or Visit 2.
* Ongoing or recurrent infections requiring systemic antibiotics.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Scottsboro, Alabama, United States
GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Newport Beach, California, United States
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Winter Park, Florida, United States
GSK Investigational Site
Adairsville, Georgia, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Chapel Hill, North Carolina, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Mooresville, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Toledo, Ohio, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Medford, Oregon, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Boerne, Texas, United States
GSK Investigational Site
Williamsburg, Virginia, United States
GSK Investigational Site
Madison, Wisconsin, United States
GSK Investigational Site
Woodville South, South Australia, Australia
GSK Investigational Site
Clayton, Victoria, Australia
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Parkville, Victoria, Australia
GSK Investigational Site
Sherwood Park, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Hamilton, Ontario, Canada
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Trois-Rivières, Quebec, Canada
GSK Investigational Site
Québec, , Canada
GSK Investigational Site
Guadalajara, Jalisco, Mexico
GSK Investigational Site
Cuernavaca, Morelos, Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico
GSK Investigational Site
Villahermosa, Tabasco, Mexico
GSK Investigational Site
Mérida, Yucatán, Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
México DF, , Mexico
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Kemerovo, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Samara, , Russia
GSK Investigational Site
Tomsk, , Russia
GSK Investigational Site
Ulyanovsk, , Russia
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-001072-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
207597
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.