Community Influenza

• Register: EUCTR
• Last refreshed on: 17 October 2016
• Main ID: EUCTR2014-004068-39-LV
• Date of registration: 11/11/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: Community Influenza
• Scientific title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study of 2 Dose Levels of VX 787 Administered as Monotherapy and One Dose Level of VX-787 Administered in Combination With Oseltamivir for the Treatment of Acute Uncomplicated Seasonal Influenza A in Adult Subjects
• Date of first enrolment: 19/12/2014
• Target sample size: 1610
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004068-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Canada, Estonia, Germany, Latvia, South Africa, United States

Contacts

• Name: Clinical Trials and Medical Info
• Affiliation: Vertex Pharmaceuticals Incorporated

• Name: Clinical Trials and Medical Info
• Affiliation: Vertex Pharmaceuticals Incorporated

Key inclusion & exclusion criteria

Inclusion criteria:
• Willing and able to comply with study requirements including treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
• Subjects have an oral temperature of =38°C (100.4°F) within the prior 24 hours and at least 1 respiratory and at least 1 systemic symptom
• Subjects have a documented oral temperature of =38°C (100.4°F) during the screening visit unless antipyretic medication had been administered within the past 6 hours, in which case a normal temperature at screening is acceptable, so long as the patient had a fever =38°C at some time prior to taking the medication , and at least 1 respiratory and at least 1 systemic symptom, both scored as at least “moderate” when self-assessed with a symptom assessment scale.
• The onset of flu-like symptoms must be =48 hours before receiving study drug.
• Subjects must be positive for influenza A with a rapid influenza diagnostic test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1610
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Any history of illness, comorbidity or lab abnormality, particularly pulmonary, cardiac or diabetes that might confound the results of the study or pose an additional risk in administering study drug to the subject.
• Use of a live attenuated intranasal spray vaccine (e.g. Flumist©) in the 3 weeks before study entry.
• Subjects who have taken antiviral medication within 14 days before screening.
• Pregnant and nursing females, sexually active subjects or reproductive potential who are not willing to follow the contraception requirements.
• Subjects may not participate in an investigational study drug until the completion of this study.
• Subjects with bacterial infections requiring systemic antibacterial agents at the time of screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Influenza A
MedDRA version: 18.1 Level: HLT Classification code 10022005 Term: Influenza viral infections System Organ Class: 100000004862

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: VX-787
Product Code: VX-787
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-787
Other descriptive name: VX-787
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: VX-787
Product Code: VX-787
Pharmaceutical Form: Tablet
INN or Proposed INN: VX-787
Other descriptive name: VX-787
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Tamiflu
Product Name: Tamiflu
Pharmaceutical Form: Capsule
INN or Proposed INN: OSELTAMIVIR
CAS Number: 196618-13-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Through day 14

Main Objective: The primary objectives of the study is to evaluate the time to resolution of influenza symptoms in adults with acute uncomplicated seasonal influenza A following administration of VX-787, with and without concomitant oseltamivir.

Secondary Objective: The secondary objectives are to evaluate:
• Safety and tolerability of administration of VX-787 with and without concurrent oseltamivir in adults with acute uncomplicated seasonal influenza A
• Antiviral effect, as measured by viral titer in nasal secretions, of administration of 2 dose levels of VX-787 as a monotherapy and of 1 dose level of VX-787 in combination with oseltamivir in adults with acute uncomplicated seasonal influenza A
• Change in the duration and severity of clinical symptoms
• Pharmacokinetics of VX-787, administered as a monotherapy and in combination with oseltamivir
• Assessment of viral sequences for changes that may be associated with resistance to VX-787 and/or oseltamivir

Primary end point(s): The primary endpoint is the time from initiation of VX-787 dosing to resolution of influenza symptoms as assessed by clinical symptom scores.

Secondary Outcome(s)

Secondary end point(s): • Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs
• Antiviral effect and viral kinetics in relation to:
o Duration of viral shedding in nasal secretions by qRT-PCR and viral culture
o Viral area under the concentration time curve (AUC) calculated by qRT-PCR and viral culture of nasal secretions, from baseline to Day 8
o Peak viral shedding titer by qRT-PCR and viral culture
• Clinical symptom scores
o Composite symptom score AUC
o Time to peak of composite symptom score,
o Duration and time to resolution of composite symptom score from peak
• PK parameters of VX-787, as determined by population analysis
• Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir

Timepoint(s) of evaluation of this end point: Through day 14

Secondary ID(s)

2014-004068-39-EE

VX14-787-103

Source(s) of Monetary Support

Janssen Research & Development