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Chronic Idiopathic UrticariaPhase 3NCT01287117

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

A Phase 3 study testing Omalizumab in people with Chronic Idiopathic Urticaria, run by Genentech, Inc. at 66 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
319 participants
Where
66 sitesin 8 countries
Study dates
Feb 2011to Oct 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) 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 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

66 sites in 8 countries.

66 sites in 8 countries

United States40 sites

  • Study site

    Baltimore, Massachusetts, 21224

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Edison, New Jersey, 08820

  • Study site

    Fort Worth, Texas, 76123

  • Study site

    Houston, Texas, 77054

  • Study site

    Huntington Beach, California, 92647

  • Study site

    Indianapolis, Indiana, 46208

  • Study site

    La Crosse, Wisconsin, 54601

  • Study site

    Long Beach, California, 90808

  • Study site

    Los Angeles, California, 90027

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Palmdale, California, 93551

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Portland, Oregon, 97210

  • Study site

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Jose, California, 95117-1840

  • Study site

    Sandy City, Utah, 84070

  • Study site

    Sarasota, Florida, 34233

  • Study site

    Skillman, New Jersey, 08558

  • Study site

    Springfield, Illinois, 62703

  • Study site

    Springfield, Virginia, 22152

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Staten Island, New York, 10304

  • Study site

    Studio City, California, 91607

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    The Bronx, New York, 10465

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Upland, Pennsylvania, 19013

  • Study site

    Waco, Texas, 76712

  • Study site

    Washington D.C., District of Columbia, 20037

Other trials in United States

Germany8 sites

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 10249

  • Study site

    Berlin, D-13585

  • Study site

    Dresden, D-01062

  • Study site

    Freiburg im Breisgau, 79098

  • Study site

    Heidelberg, 69115

  • Study site

    München, 80337

  • Study site

    Münster, 48149

Other trials in Germany

Poland4 sites

  • Study site

    Krakow, 31-531

  • Study site

    Lodz, 90-153

  • Study site

    Lublin, 20-718

  • Study site

    Wroclaw, 51-124

Other trials in Poland

France3 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Marseille, 13385

  • Study site

    Reims, 51092

Other trials in France

Italy3 sites

  • Study site

    Perugia, 06159

  • Study site

    Roma, 00167

  • Study site

    Terni, 05100

Other trials in Italy

Spain3 sites

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08041

  • Study site

    Pamplona, 31003

Other trials in Spain

Turkey (Türkiye)3 sites

  • Study site

    Ankara, 06500

  • Study site

    Bursa, 16059

  • Study site

    Istanbul, 35100

Other trials in Turkey (Türkiye)

Denmark2 sites

  • Study site

    Copenhagen, 2400

  • Study site

    Odense, 5000

Other trials in Denmark

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) 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-dose H1 antihistamine treatment.

Read the detailed description

Type I Error Rate Control Plan

Primary Outcome Measure

In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value < 0.05 is only considered statistically significant if statistical significance was 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

Secondary Outcome Measures

A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value < 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.

  • Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7)
  • Stage 2: Change from Baseline to Week 12 in the weekly number of hives score
  • Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12
  • Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12
  • Stage 5: Percentage of weekly itch severity score MID responders at Week 12
  • Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score
  • Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
  • Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
  • Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12
Being tested
Omalizumab, Placebo
Medical subject headings
Chronic Urticaria

What participants receive

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

  • OmalizumabDrug

    Also called Xolair

    Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

  • PlaceboDrug

    Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Study groups in NCT01287117
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Receives: Drug: Placebo
Omalizumab 75 mgExperimentalParticipants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
Receives: Drug: Omalizumab
Omalizumab 150 mgExperimentalParticipants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
Receives: Drug: Omalizumab
Omalizumab 300 mgExperimentalParticipants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Receives: Drug: Omalizumab

What is being measured

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

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

    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 to Week 12

Secondary outcomes (9)

  1. Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)

    The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.

    Measured: Baseline to Week 12

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

    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 to Week 12

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

    The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.

    Measured: Baseline to Week 12

  4. Percentage of Participants With a UAS7 Score ≤ 6 at Week 12

    The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.

    Measured: Week 12

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

    The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.

    Measured: Baseline to Week 12

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

    The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated 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 to Week 12

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

    The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated 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 to 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 for which a patient responded "No" to the angioedema question 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

  9. Percentage of Complete Responders (UAS7 = 0) at Week 12

    A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.

    Measured: 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 posted1 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2012
  4. Study completionOct 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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01287117
Sponsor's protocol ID
Q4881g
Other IDs
GA00887
Status last verified
Nov 2013
First submitted
27 Jan 2011
Last updated
27 Nov 2013

Publications

  • Mosnaim G, Seetasith A, Holden M, Trzaskoma BL, Saini SS. Matching-adjusted indirect comparison analysis of omalizumab versus dupilumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol Glob. 2026 Feb 14;5(3):100668. doi: 10.1016/j.jacig.2026.100668. eCollection 2026 May.

    PubMed 41847564

  • 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

  • Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bulbul Baskan E, Bradley MS, Canvin J, Rahmaoui A, Georgiou P, Alpan O, Spector S, Rosen K. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015 Jan;135(1):67-75. doi: 10.1038/jid.2014.306. Epub 2014 Jul 21.

    PubMed 25046337

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 66 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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Germany, Poland, France, Italy 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. Some participants in this study may receive a placebo. 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 18 Oct 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 to Week 12 in the Weekly Itch Severity Score (time frame: Baseline to 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 NCT01287117, which also lists 9 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 27 Nov 2013.

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