Chronic Idiopathic UrticariaNCT02814630
Three-month, Single-center Study to Identify Biomarkers/Response to Xolair Therapy in Chronic Idiopathic Urticaria
A study testing Xolair in people with Chronic Idiopathic Urticaria, run by Asthma Inc Clinical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- Xolair
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 2 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.*
Who cannot join
- • 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*
Trial locations and contacts
1 site in 1 country.
United States1 site
ASTHMA Inc Clinical Research Center
Seattle, Washington, 98115
About this study
Official title: Three-month, Single-center Study to Identify Biomarkers (Plasma Exosomal miRNAs) and Mechanism of Response (Basophil Transcriptome Analysis) to Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria
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.
Read the detailed description
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. After an initial screening visit within two weeks of the Day 1 baseline visit, patients receive one subcutaneous injection of omalizumab at a dose of 300 mg on Days 1, 30, and 60. Patients will return for clinical assessments and blood draws on Day 3 and Day 30 (study conclusion). Blood will be collected at the screening visit (Day -14), baseline (Day 1, prior to omalizumab injection), Day 14, Day 30 (prior to omalizumab injection), Day 60 (prior to omalizumab injection), and Day 90 (study completion) for microsomal miRNA extraction, basophil isolation, and also stored at -70oC for later periostin assays for a total of 275ml of blood over the course of the study (25ml at screening and 50ml for each of the 5 subsequent visits (i.e., Days 1, 14, 30, 60, and 90). Plasma exosomal miRNA bioinformatics analyses will be conducted in early (i.e., Day 14) and later (i.e., Day 30, 60, 90) responder groups. The 2 wk time point will capture the early responders and the 4, 8, and 12 wk time points will capture the remaining responder groups based on the following: Two Phase III, global, multicenter, randomized, double-blind, placebo-controlled trials (Appendix B, CIU Study 1 and CIU Study 2 data) and data of CIU patients with a starting UAS7 score of 25.3 ± 2.0 (mean ± SEM) treated with Xolair® outside of clinical trials (Metz et al., 2014), where 57% attained complete response within one week of their first treatment and a further 29% within 4 weeks (Metz et al., 2014).
To address the role/mechanism of basophils in the immunopathogenesis of chronic urticaria, we will do basophil mRNA/miRNA arrays.
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- Xolair
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairBiological
Also called Omalizumab
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Xolair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 week period of Xolair® treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2016
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asthma Inc Clinical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- William Henderson, MD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814630
- Sponsor's protocol ID
- CIGE025EUS44T
- Status last verified
- Jan 2019
- First submitted
- 31 May 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: A paper may be written but individual participant data will not be made available
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-month, Single-center Study to Identify Biomarkers (Plasma Exosomal miRNAs) and Mechanism of Response (Basophil Transcriptome Analysis) to Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria
- ClinicalTrials.gov ID
- NCT02814630
- Acronym / sponsor ID
- CIGE025EUS44T
- Conditions
- Chronic Idiopathic Urticaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asthma Inc Clinical Research CenterUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Sep 2016 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. After an initial screening visit within two weeks of the Day 1 baseline visit, patients receive one subcutaneous injection of omalizumab at a dose of 300 mg on Days 1, 30, and 60. Patients will return for clinical assessments and blood draws on Day 3 and Day 30 (study conclusion). Blood will be collected at the screening visit (Day -14), baseline (Day 1, prior to omalizumab injection), Day 14, Day 30 (prior to omalizumab injection), Day 60 (prior to omalizumab injection), and Day 90 (study completion) for microsomal miRNA extraction, basophil isolation, and also stored at -70oC for later periostin assays for a total of 275ml of blood over the course of the study (25ml at screening and 50ml for each of the 5 subsequent visits (i.e., Days 1, 14, 30, 60, and 90). Plasma exosomal miRNA bioinformatics analyses will be conducted in early (i.e., Day 14) and later (i.e., Day 30, 60, 90) responder groups. The 2 wk time point will capture the early responders and the 4, 8, and 12 wk time points will capture the remaining responder groups based on the following: Two Phase III, global, multicenter, randomized, double-blind, placebo-controlled trials (Appendix B, CIU Study 1 and CIU Study 2 data) and data of CIU patients with a starting UAS7 score of 25.3 ± 2.0 (mean ± SEM) treated with Xolair® outside of clinical trials (Metz et al., 2014), where 57% attained complete response within one week of their first treatment and a further 29% within 4 weeks (Metz et al., 2014).
To address the role/mechanism of basophils in the immunopathogenesis of chronic urticaria, we will do basophil mRNA/miRNA arrays.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Xolair | Other | Biological: XolairThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • at least 6 weeks of chronic idiopathic urticaria with itching despite current use of up to x4 H1-antihistamines (Kaplan, 2004)
Key exclusion criteria (7 listed)
- • a clearly defined underlying cause for chronic urticaria (e.g., physical urticaria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairAlso: OmalizumabThe 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) | Biological | Open-label Xolair |
Primary outcome
miRNAs in the blood differentially expressed after treatment with Xolair® in patients with chronic idiopathic urticaria.
Time frame: 12 week period of Xolair® treatment
Identification of specific miRNA(s) that are novel biomarker(s) predicting response to Xolair® treatment in 20 patients with chronic idiopathic urticaria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: Undecided. A paper may be written but individual participant data will not be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Henderson, MD study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xolair in people with Chronic Idiopathic Urticaria, run by Asthma Inc Clinical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNAs in the blood differentially expressed after treatment with Xolair® in patients with chronic idiopathic urticaria. (time frame: 12 week period of Xolair® treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.