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Chronic Idiopathic UrticariaPhase 3NCT01292473

A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

A Phase 3 study testing Omalizumab in people with Chronic Idiopathic Urticaria, run by Genentech, Inc. at 61 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU… Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Chronic Idiopathic Urticaria
What is being tested?
Omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
323 participants
Where
61 sitesin 8 countries
Study dates
Mar 2011to Jun 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) CIU/CSU refractory to H1 antihistamines at the time of randomization.

Who cannot join

  • Treatment with an investigational agent within 30 days prior to screening.
  • Weight < 20 kg (44 lbs).
  • Clearly defined underlying etiology for chronic urticarias other than CIU.
  • Evidence of parasitic infection.
  • Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch.
  • Previous treatment with omalizumab within a year prior to screening.
Show all 18Show fewer
  • Routine doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
  • Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
  • Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.
  • Any H2 antihistamine use within 7 days prior to screening.
  • Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to screening.
  • Any H1 antihistamines at greater than approved doses within 3 days prior to screening.
  • Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
  • Hypersensitivity to omalizumab or any component of the formulation.
  • History of anaphylactic shock.
  • Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
  • Evidence of current drug or alcohol abuse.
  • Nursing women or women of childbearing potential, unless they meet the following definition of post-menopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 milli-international units per milliliter (mIU/mL) or 6 weeks post surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods.

Trial locations and contacts

61 sites in 8 countries.

61 sites in 8 countries

United States36 sites

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Bayside, New York, 11361

  • Study site

    Brick, New Jersey, 08724

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Canton, Ohio, 44718

  • Study site

    Cincinnati, Ohio, 45231

  • Study site

    Denver, Colorado, 80206

  • Study site

    El Paso, Texas, 79903

  • Study site

    Indianapolis, Indiana, 46256

  • Study site

    La Jolla, California, 92037

  • Study site

    Los Angeles, California, 90045

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Miami, Florida, 33173

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    North Syracuse, New York, 13212

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Overland Park, Kansas, 66210

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Redwood City, California, 94063

  • Study site

    Rochester, New York, 14642

  • Study site

    Rockville Centre, New York, 11570

  • Study site

    Sandy City, Utah, 84070

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Seattle, Washington, 98105

  • Study site

    Shiloh, Illinois, 62269

  • Study site

    Spokane, Washington, 99204

  • Study site

    The Bronx, New York, 10461

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Wheaton, Maryland, 20902

  • Study site

    Woodstock, Georgia, 30188

  • Study site

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany6 sites

  • Study site

    Bonn, 53127

  • Study site

    Hanover, 30449

  • Study site

    Leipzig, D-'04103

  • Study site

    Mainz, 55131

  • Study site

    München, 80802

  • Study site

    Münster, 48149

Other trials in Germany

Poland5 sites

  • Study site

    Gdansk, 80-211

  • Study site

    Krakow, 31-913

  • Study site

    Lodz, 90-265

  • Study site

    Warsaw, 02-256

  • Study site

    Wroclaw, 54-239

Other trials in Poland

Turkey (Türkiye)4 sites

  • Study site

    Ankara, 06100

  • Study site

    Istanbul, 34372

  • Study site

    Izmir, 35100

  • Study site

    Kayseri, 38039

Other trials in Turkey (Türkiye)

France3 sites

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06200

  • Study site

    Paris, 75475

Other trials in France

Italy3 sites

  • Study site

    Genova, 16132

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

Other trials in Italy

Denmark2 sites

  • Study site

    Aarhus, 8000

  • Study site

    Copenhagen, 2900

Other trials in Denmark

Spain2 sites

  • Study site

    Barcelona, 08003

  • Study site

    Madrid, 28041

Other trials in Spain

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.

Read the detailed description

The trial incorporated a Type I error control plan, as follows:

The testing of the primary endpoint was conducted in the following hierarchical order. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.

  • Stage 1: Omalizumab 300-mg group vs. placebo
  • Stage 2: Omalizumab 150-mg group vs. placebo
  • Stage 3: Omalizumab 75-mg group vs. placebo

A hierarchical analysis of the secondary endpoints was performed for each dose found to be significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.

  • Stage 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 12
  • Stage 2: Change from baseline in the weekly number of hives score at Week 12
  • Stage 3: Time to weekly itch severity score Minimally Important Difference (MID) response at Week 12
  • Stage 4: Proportion of patients with UAS7 ≤ 6 at Week 12
  • Stage 5: Proportion of weekly itch severity score MID Responders at Week 12
  • Stage 6: Change from baseline in weekly size of the largest hive score at Week 12
  • Stage 7: Change from baseline in overall Dermatology Life Quality Index (DLQI) score at Week 12
  • Stage 8: Proportion of angioedema-free days from Week 4 to Week 12
Being tested
Placebo, Omalizumab
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo was supplied lyophilized in vials.

  • OmalizumabDrug

    Also called Xolair

    Omalizumab was supplied lyophilized in vials.

Study groups in NCT01292473
Study groupRoleWhat they receive
PlaceboExperimentalPlacebo subcutaneously (sc) every 4 weeks
Receives: Drug: Placebo; Drug: Omalizumab
Omalizumab 75 mgExperimentalOmalizumab 75 mg sc every 4 weeks
Receives: Drug: Omalizumab
Omalizumab 150 mgExperimentalOmalizumab 150 mg sc every 4 weeks
Receives: Drug: Omalizumab
Omalizumab 300 mgExperimentalOmalizumab 300 mg sc every 4 weeks.
Receives: Drug: Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Weekly Itch Severity Score at Week 12

    The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.

    Measured: Baseline, Week 12

Secondary outcomes (8)

  1. Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12

    The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.

    Measured: Baseline, Week 12

  2. Change From Baseline in the Weekly Number of Hives Score at Week 12

    The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.

    Measured: Baseline, Week 12

  3. Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12

    The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.

    The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved.

    Measured: by Week 12

  4. Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12

    The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.

    Measured: Week 12

  5. Percentage of Weekly Itch Severity Score MID Responders at Week 12

    The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.

    The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline.

    Measured: Baseline, Week 12

  6. Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12

    The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.

    Measured: Baseline, Week 12

  7. Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12

    The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.

    Measured: Baseline, Week 12

  8. Percentage of Angioedema-free Days From Week 4 to Week 12

    The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.

    Measured: Week 4 to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01292473
Sponsor's protocol ID
Q4882g
Status last verified
Oct 2013
First submitted
7 Feb 2011
Last updated
11 Oct 2013
Data monitoring committee
No

Publications

  • Casale TB, Trzaskoma B, Holden M, Bernstein JA, Maurer M. Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab? World Allergy Organ J. 2024 Aug 5;17(8):100943. doi: 10.1016/j.waojou.2024.100943. eCollection 2024 Aug.

    PubMed 39193419

  • Ferrer M, Gimenez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, Risson V. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1191-1197.e5. doi: 10.1016/j.jaip.2018.04.003. Epub 2018 Apr 12.

    PubMed 29655772

  • Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: Review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017 Apr;118(4):500-504. doi: 10.1016/j.anai.2017.02.003.

    PubMed 28390587

  • Saini SS, Omachi TA, Trzaskoma B, Hulter HN, Rosen K, Sterba PM, Courneya JP, Lackey A, Chen H. Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria. J Invest Dermatol. 2017 Apr;137(4):958-961. doi: 10.1016/j.jid.2016.11.025. Epub 2016 Dec 6. No abstract available.

    PubMed 27939380

  • Gimenez-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosen K, Omachi TA, Stull D, Balp MM, Murphy T. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0. eCollection 2016.

    PubMed 27540466

  • Zazzali JL, Kaplan A, Maurer M, Raimundo K, Trzaskoma B, Solari PG, Antonova E, Mendelson M, Rosen KE. Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):370-377.e1. doi: 10.1016/j.anai.2016.06.024. Epub 2016 Jul 14.

    PubMed 27424128

  • Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, Grattan CE, Gimenez-Arnau A, Kaplan AP, Rosen K. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.

    PubMed 26054553

  • Maurer M, Rosen K, Hsieh HJ, Saini S, Grattan C, Gimenez-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24.

    PubMed 23432142

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omalizumab in people with Chronic Idiopathic Urticaria, run by Genentech, Inc. at 61 sites in 8 countries.

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 1 inclusion and 18 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 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Germany, Poland, Turkey (Türkiye), France and 3 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in the Weekly Itch Severity Score at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01292473, which also lists 8 linked publications.

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 11 Oct 2013.

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