NCT02814630

Brief Summary

This is a single center, non-comparative exploratory study, to investigate the effect of omalizumab over a 3-month treatment period in adult (≥18 years) patients with chronic idiopathic urticaria who had remained symptomatic despite the use of high dose H1-antihistamines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 31, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

May 31, 2016

Last Update Submit

January 22, 2019

Conditions

Chronic Idiopathic Urticaria

Outcome Measures

Primary Outcomes (1)

  • miRNAs in the blood differentially expressed after treatment with Xolair® in patients with chronic idiopathic urticaria.

    Identification of specific miRNA(s) that are novel biomarker(s) predicting response to Xolair® treatment in 20 patients with chronic idiopathic urticaria.

    12 week period of Xolair® treatment

Study Arms (1)

Open-label Xolair

OTHER

The patients will receive one subcutaneous injection of omalizumab at a dose of 300 mg on Days 1, 30, and 60. There is no control drug.

Biological: Xolair

Interventions

XolairBIOLOGICAL

The patients will receive one subcutaneous injection of Xolair® (omalizumab) at a dose of 300 mg on Days 1, 30, and 60. This dose is based on the results of the international, multicenter, randomized, double-blind, placebo-controlled study which demonstrated that omalizumab significantly decreased clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of H1-antihistamines (Maurer et al., 2013)

Also known as: Omalizumab
Open-label Xolair

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 6 weeks of chronic idiopathic urticaria with itching despite current use of up to x4 H1-antihistamines (Kaplan, 2004)
  • an urticaria activity score (UAS) during a 7-day period (UAS7) of 16 or more (on a scale ranging from 0 to 42, with higher scores indicating greater activity and a minimally important difference \[MID\] of 9.5 to 10.5) (Mathias et al., 2012)
  • a weekly itch-severity score (ISS) of 8 or more (on a scale ranging from 0 to 21, with higher scores indicating more severe itching and an MID of ≥5) during the 7 days before first treatment with omalizumab.
  • All females of childbearing potential must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative urine pregnancy test.\*

You may not qualify if:

  • a clearly defined underlying cause for chronic urticaria (e.g., physical urticaria)
  • routine administration (i.e., daily or every other day for ≥5 consecutive days) of systemic glucocorticoids, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, or intravenous immune globulin within the previous 30 days
  • the use of any H2-antihistamine or leukotriene-receptor antagonist within 7 days preceding the screening visit
  • a history of cancer
  • a known hypersensitivity to omalizumab
  • treatment with omalizumab within the previous year, or
  • pregnant or nursing females\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASTHMA Inc Clinical Research Center

Seattle, Washington, 98115, United States

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

  • William Henderson, MD

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 28, 2016

Study Start

September 1, 2016

Primary Completion

November 2, 2018

Study Completion

November 2, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

US(1)