Safety, Tolerability and Pharmacokinetics of Multiple Dos... | NCT00929968

Studies
Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis

NCT00929968

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

35Actual

Phase

Phase 2

Conditions

Allergic Rhinitis

Interventions

Placebo
VAK694
Fluticasone

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Feb 2011Actual

Completion Date

Not provided

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Jun 29, 2009

First Posted Date

Jun 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

May 2, 2012

Certification/Extension First Submitted that Passed QC Review

May 2, 2012

Certification/Extension First Posted Date

May 4, 2012Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 19, 2020Actual

Description Module

Brief Summary

This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo to VAK694	Placebo Comparator	Biological: Placebo
VAK694	Experimental	Biological: VAK694
Fluticasone propionate	Active Comparator	Drug: Fluticasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Biological		Placebo to VAK694
VAK694

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects		12 weeks
Change in serum levels of total and antigen specific IgE and total and antigen specific IgG		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects between ages of 18 to 60 in good health
History of atopy for at least 2 years and positive skin prick test to ragweed allergen

Exclusion criteria:

History of asthma treated with corticosteroids
Smokers with a smoking history of > 10 pack/years or smoking in the past year
History of chronic obstructive pulmonary disease

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altoona Center for Clinical Research		Duncansville	Pennsylvania	16635	United States
Novartis Investigative Site

References Module

Citations

Not provided

ID	Term
D065631	Rhinitis, Allergic
D006255	Rhinitis, Allergic, Seasonal

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473