Efficacy and Safety of Omalizumab in Chronic Idiopathic U... | NCT02166151

Studies
Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

NCT02166151

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Jun 18, 2014Estimated

Enrollment

20Estimated

Phase

Phase 3

Conditions

Chronic Idiopathic Urticaria

Interventions

Omalizimab

Countries

Israel

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Jun 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

May 28, 2014

First Submission Date that Met QC Criteria

Jun 17, 2014

First Posted Date

Jun 18, 2014Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2014

Last Update Posted Date

Jun 18, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is designed to assess the efficacy and safety of monthly injections of Omalizumab 150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive to convetional therapy by antihistamins or oral corticosteroids.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omalizumab	Experimental	Omalizimab 150 mg S.C. once a month for consecutive 3 months	Drug: Omalizimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omalizimab	Drug	Omalizimab 150 mg S.C. once a month for consecutive 3 months	Omalizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of chronic idiopathic urticaria for 3 months
failure on treatment with at least 2 antihistamins and systemic corticosteroids or cyclosporin

Exclusion Criteria:

physical or cholinergic urticaria
past treatment in Omalizumab i nprevious year
parasitic infection
malignancy in last 5 years
known sensitivity to Omalizumab

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael David, Prof	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center		Petah Tikva	Israel	49100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000080223	Chronic Urticaria

Ancestor Terms

ID	Term
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069444	Omalizumab

Ancestor Terms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided