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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03085797


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT03085797
Ethics application status
Date submitted
15/03/2017
Date registered
21/03/2017

Titles & IDs
Public title
Effect of Mepolizumab in Severe Bilateral Nasal Polyps
Scientific title
A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps - SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)
Secondary ID [1] 0 0
2016-004255-70
Secondary ID [2] 0 0
205687
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasal Polyps 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mepolizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Mometasone furoate

Experimental: Mepolizumab 100 mg SC + MF - Participants will receive total thirteen doses of 100 mg SC of mepolizumab in thigh, abdomen or upper arm every 4 weeks for 52 weeks on top of SoC which includes daily nasal spray of mometasone furoate.

Placebo comparator: Placebo SC + MF - Participants will receive total thirteen doses of SC matching placebo in thigh, abdomen or upper arm every 4 weeks for 52 weeks on top of SoC which includes daily nasal spray of mometasone furoate.


Treatment: Drugs: Mepolizumab
Mepolizumab injection 100 mg/millilitre (mL) is a clear to opalescent, colorless to pale yellow to pale brown sterile solution for SC injection in a single-use, safety syringe.

Treatment: Drugs: Placebo
Placebo is a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe.

Treatment: Drugs: Mometasone furoate
All participants will receive mometasone furoate usually 400 micrograms (mcg), 2 actuations (50 mcg/actuation) in each nostril twice daily. Intolerant participants will use 200g (2 actuations \[50 g/actuation\] in each nostril once daily).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 52
Timepoint [1] 0 0
Baseline (Day 1) and Week 52
Primary outcome [2] 0 0
Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52
Timepoint [2] 0 0
Baseline and Weeks 49 to 52
Secondary outcome [1] 0 0
Percentage of Participants With Nasal Surgery Over Time
Timepoint [1] 0 0
Weeks 8, 16, 24, 32, 40, 48 and 52
Secondary outcome [2] 0 0
Change From Baseline in Overall VAS Score During the 4 Weeks Prior to Week 52
Timepoint [2] 0 0
Baseline and Weeks 49 to 52
Secondary outcome [3] 0 0
Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52
Timepoint [3] 0 0
Baseline (Day 1) and Week 52
Secondary outcome [4] 0 0
Percentage of Participants Requiring at Least One Course of Systemic Steroids for Nasal Polyps up to Week 52
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
Change From Baseline in the Composite VAS Score (Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell) During the 4 Weeks Prior to Week 52
Timepoint [5] 0 0
Baseline and Weeks 49 to 52
Secondary outcome [6] 0 0
Change From Baseline in Individual VAS Symptom Score: Loss of Smell During the 4 Weeks Prior to Week 52
Timepoint [6] 0 0
Baseline and Weeks 49 to 52

Eligibility
Key inclusion criteria
Inclusion Criteria

* 18 years of age and older inclusive, at the time of signing the informed consent.
* Body weight greater or equal to 40 kilogram (kg).
* Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study. To be eligible for entry into the study, woman of childbearing potential (WOCBP) must commit to consistent and correct use of an acceptable method of birth control from the time of consent, for the duration of the trial, and for 105 days after last study drug administration.
* Participants who have had at least one previous surgery in the previous 10 years for the removal of NP. NP Surgery is defined as any procedure involving instruments with resulting incision (cutting open) and removal of polyp tissue from the nasal cavity (polypectomy). For the purpose of inclusion into this study, any procedure involving instrumentation in the nasal cavity resulting in dilatation of the nasal passage such as balloon sinuplasty, insertion of coated stents or direct injection of steroids or other medication without any removal of NP tissue is not accepted.
* Participants with bilateral NP as diagnosed by endoscopy or computed tomography (CT) scan.
* Presence of at least two of the following symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip) and either nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell for at least 12 weeks prior to screening.
* Participants with severe NP symptoms defined as an obstruction VAS symptom score of >5.
* Severity consistent with a need for surgery as described by:

1. Participants with an overall VAS symptom score >7,
2. Participants with an endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
* Treatment with intranasal corticosteroids (INCS) for at least 8 weeks prior to screening.
* Capable of giving signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
* As a result of medical interview, physical examination, or screening investigation, the physician responsible considers the participant unfit for the study.
* Cystic fibrosis
* Eosinophilic granulomatosis with polyangiitis (also known as churg strauss syndrome), young's, kartagener's or dyskinetic ciliary syndromes.
* Antrochoanal polyps
* Nasal septal deviation occluding one nostril
* Acute sinusitis or upper respiratory track infection (URTI) at screening or in 2 weeks prior to screening
* Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis)
* Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening.
* Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior Visit 1.
* Participants where NP surgery is contraindicated in the opinion of the Investigator.
* Participants with a known medical history of human immunodeficiency virus (HIV) infection.
* Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
* Participants who are currently receiving, or have received within 3 months (or 5 half lives - whatever is the longest) prior to first mepolizumab dose, chemotherapy, radiotherapy or investigational medications/therapies.
* Participants with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK medical monitor, contraindicates their participation. Aspirin-sensitive participants are acceptable.
* Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.
* Participants on a waiting list for NP surgery while at screening
* Participants that have taken part in previous mepolizumab, reslizumab, dupilumab or benralizumab studies.
* Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (intranasal corticosteroid is accepted) within 4 weeks prior to Screening or planned use of such medications during the double-blind period.
* INCS dose changes within 1 month prior to screening.
* Treatments with biological or immunosuppressive treatment (other than omalizumab) treatment within 5 terminal phase half lives of Visit 1.
* Omalizumab treatment in the 130 days prior to Visit 1.
* Commencement of leukotriene antagonist treatment less than 30 days prior to Visit 1.
* Allergen immunotherapy within the previous 3 months.
* Women who are pregnant or lactating or are planning on becoming pregnant during the study.
* Participants who currently smoke or have smoked in the last 6 months.
* Any participant who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any participant who has any other condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
* Participants who have known, pre-existing, clinically significant endocrine, autoimmune, cardiovascular, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment.
* Immunocompromized, other than that explained by the use of corticosteroids taken as therapy.
* A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening. Participants with successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, with no evidence of recurrence may participate in the study.
* Current active liver or biliary disease (with the exception of gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
* Corrected QT interval (QTc) >450 milliseconds (msec) or QTc >480 msec in participants with bundle branch block at visit 1.
* A known or suspected history of alcohol or drug abuse within 2 years prior to Screening (Visit 1) that in the opinion of the investigator would prevent the participant from completing the study procedures.
* An investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
* In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/12/2019
Sample size
Target
Accrual to date
Final
414
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3169 - Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Santa Fe
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma de Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad Autónoma de Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Mendoza
Country [27] 0 0
Argentina
State/province [27] 0 0
San Miguel de Tucumán
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
Country [32] 0 0
Canada
State/province [32] 0 0
Québec
Country [33] 0 0
Germany
State/province [33] 0 0
Baden-Wuerttemberg
Country [34] 0 0
Germany
State/province [34] 0 0
Bayern
Country [35] 0 0
Germany
State/province [35] 0 0
Hessen
Country [36] 0 0
Germany
State/province [36] 0 0
Nordrhein-Westfalen
Country [37] 0 0
Germany
State/province [37] 0 0
Sachsen
Country [38] 0 0
Germany
State/province [38] 0 0
Schleswig-Holstein
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Incheon
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seongnam-si Gyeonggi-do
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Netherlands
State/province [43] 0 0
Amsterdam
Country [44] 0 0
Romania
State/province [44] 0 0
Brasov
Country [45] 0 0
Romania
State/province [45] 0 0
Bucuresti
Country [46] 0 0
Romania
State/province [46] 0 0
Cluj Napoca
Country [47] 0 0
Romania
State/province [47] 0 0
Targu Mures
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Moscow
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint-Peterburgh
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saint-Petersburg
Country [51] 0 0
Russian Federation
State/province [51] 0 0
St. Petersburg
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Yaroslavl
Country [53] 0 0
Sweden
State/province [53] 0 0
Göteborg
Country [54] 0 0
Sweden
State/province [54] 0 0
Helsingborg
Country [55] 0 0
Sweden
State/province [55] 0 0
Lund
Country [56] 0 0
Sweden
State/province [56] 0 0
Stockholm
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Durham
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Merseyside
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Manchester
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Newcastle upon Tyne
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Rotherham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CRF health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Bristol-Myers Squibb
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=20845


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03085797

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,WA,VIC
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
GlaxoSmithKline
Primary sponsor address
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
 
Public notes
Australian Investigators:
Chady Sader, TrialsWest, Western Australia, Murdoch, Australia, 6150
Andrew Gillman, Alfred Hospital, Victoria, Melbourne, Australia, 3004
Richard Harvey, Sydney Ear Nose and Throat Clinic, New South Wales, Darlinghurst, Australia, 2010
Sara Barnes, Monash Medical Centre, Victoria, Clayton, Australia, 3169
Narinder Singh, Westmead Hospital, New South Wales, Westmead, Australia, 2145

Contacts
Principal investigator
Title 33 0
Name 33 0
Address 33 0
Country 33 0
Phone 33 0
Fax 33 0
Email 33 0
Contact person for public queries
Title 34 0
Name 34 0
Address 34 0
Country 34 0
Phone 34 0
Fax 34 0
Email 34 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries
Title 35 0
Name 35 0
Address 35 0
Country 35 0
Phone 35 0
Fax 35 0
Email 35 0
GSKClinicalSupportHD@gsk.com