Clinical Trial Results:
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications

Trial information Top of page
Trial identification
Sponsor protocol code	63623872FLZ3002
Additional study identifiers
ISRCTN number	-
US NCT number	NCT03381196
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Janssen Research & Development, LLC
Sponsor organisation address	920 Route 202, Raritan, United States, NJ 08869
Public contact	Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
Scientific contact	Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	Yes
EMA paediatric investigation plan number(s)	EMEA-001975-PIP01-16
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	24 Aug 2020
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	24 Aug 2020
Was the trial ended prematurely?	Yes
General information about the trial
Main objective of the trial	The primary objective is to evaluate superiority of pimodivir (Pi) in combination with standard-of-care (SOC) treatment (tmt) compared to placebo in combination with SOC treatment, with respect to the time to resolution of influenza-related symptoms.
Protection of trial subjects	Safety assessments included AE, laboratory parameters, electrocardiogram [ECG], and vital signs.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	20 Dec 2017
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Poland: 3
Country: Number of subjects enrolled	Spain: 2
Country: Number of subjects enrolled	Sweden: 1
Country: Number of subjects enrolled	United Kingdom: 1
Country: Number of subjects enrolled	Austria: 3
Country: Number of subjects enrolled	Belgium: 4
Country: Number of subjects enrolled	Bulgaria: 10
Country: Number of subjects enrolled	Estonia: 1
Country: Number of subjects enrolled	France: 2
Country: Number of subjects enrolled	Germany: 4
Country: Number of subjects enrolled	Hungary: 2
Country: Number of subjects enrolled	Italy: 3
Country: Number of subjects enrolled	Latvia: 1
Country: Number of subjects enrolled	Lithuania: 11
Country: Number of subjects enrolled	Argentina: 25
Country: Number of subjects enrolled	Brazil: 1
Country: Number of subjects enrolled	Canada: 4
Country: Number of subjects enrolled	India: 8
Country: Number of subjects enrolled	Korea, Republic of: 2
Country: Number of subjects enrolled	Mexico: 7
Country: Number of subjects enrolled	Malaysia: 1
Country: Number of subjects enrolled	Russian Federation: 2
Country: Number of subjects enrolled	South Africa: 58
Country: Number of subjects enrolled	Taiwan: 6
Country: Number of subjects enrolled	Thailand: 13
Country: Number of subjects enrolled	Turkey: 4
Country: Number of subjects enrolled	Ukraine: 10
Country: Number of subjects enrolled	United States: 355
Worldwide total number of subjects	544
EEA total number of subjects	47
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	17
Adults (18-64 years)	395
From 65 to 84 years	132
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	Study started on 24 January 2018 and completed on 24 August 2020.
Period 1
Period 1 title	Overall Period
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Pimodivir + SOC
Arm description	Subjects received pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for subjects who received only 1 dose of pimodivir on Day 1 [evening], dosing continued until the morning of Day 6) along with Standard-of-Care (SOC) treatment.
Arm type	Experimental
Investigational medicinal product name	Pimodivir
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	Pimodivir tablet was administered.
Arm title	Placebo + SOC
Arm description	Subjects received placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for subjects who received only 1 dose of placebo on Day 1 [evening], dosing continued until the morning of Day 6) along with SOC treatment.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	Placebo was administered.
Number of subjects in period 1 Pimodivir + SOC Placebo + SOC Started 273 271 Completed 261 263 Not completed 12 8      Consent withdrawn by subject 7 6      Other 5 2

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Pimodivir + SOC
Reporting group description	Subjects received pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for subjects who received only 1 dose of pimodivir on Day 1 [evening], dosing continued until the morning of Day 6) along with Standard-of-Care (SOC) treatment.
Reporting group title	Placebo + SOC
Reporting group description	Subjects received placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for subjects who received only 1 dose of placebo on Day 1 [evening], dosing continued until the morning of Day 6) along with SOC treatment.

End points Top of page

Primary: Time to Resolution of 7 Primary Influenza-related Symptoms Top of page
End point title	Time to Resolution of 7 Primary Influenza-related Symptoms
End point description
End point type	Primary
End point timeframe	Up to Day 28
End point values Pimodivir + SOC Placebo + SOC Number of subjects analysed 223 223 Units: hours     median (confidence interval 95%) 92.62 (77.60 to 104.20) 105.13 (92.73 to 128.63)
Statistical analysis title	Statistical Analysis
Comparison groups	Pimodivir + SOC v Placebo + SOC
Number of subjects included in analysis	446
Analysis specification	Pre-specified
Analysis type	other
P-value	= 0.0216
Method	Gehan-Wilcoxon test
Confidence interval

Primary: Time to Resolution of 7 Primary Influenza-related Symptoms Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	Up to Day 28
Adverse event reporting additional description	The limited results for this early terminated trial are available in the attached CSR synopsis.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	21.1
Reporting groups
Reporting group title	Pimodivir + SOC
Reporting group description	-
Reporting group title	Placebo+SOC
Reporting group description	-
Serious adverse events Pimodivir + SOC Placebo+SOC Total subjects affected by serious adverse events      subjects affected / exposed 0 / 273 (0.00%) 0 / 271 (0.00%)      number of deaths (all causes) 0 0      number of deaths resulting from adverse events
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Pimodivir + SOC Placebo+SOC Total subjects affected by non serious adverse events      subjects affected / exposed 0 / 273 (0.00%) 0 / 271 (0.00%)
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events reported.

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
The limited results for this early terminated trial are available in the attached CSR synopsis.

More information Top of page