NCT02166151

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

May 28, 2014

Last Update Submit

June 17, 2014

Conditions

Chronic Idiopathic Urticaria

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)

    3 months

Study Arms (1)

Omalizumab

EXPERIMENTAL

Omalizimab 150 mg S.C. once a month for consecutive 3 months

Drug: Omalizimab

Interventions

OmalizimabDRUG

Omalizimab 150 mg S.C. once a month for consecutive 3 months

Also known as: Xolair
Omalizumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel, 49100, Israel

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

UrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Michael David, Prof

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Michael David

Study Record Dates

First Submitted

May 28, 2014

First Posted

June 18, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 18, 2014

Record last verified: 2014-06

Locations

IL(1)