A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
NCT ID: NCT01264939
Last Updated: 2013-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
336 participants
INTERVENTIONAL
2011-02-28
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
Diphenhydramine
Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
Diphenhydramine
Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
Interventions
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Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist
Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
Diphenhydramine
Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine (up to 4 times the approved dosage), H2 blocker, and/or LTRA treatment during this time.
* Urticaria activity score over 7 days (UAS7) score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Week 0).
* In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1).
* For women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study.
Exclusion Criteria
* Weight less than 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.
* 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.
* 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.
12 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Edward R. Conner, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Brookline, Massachusetts, United States
Brookline, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Bozeman, Montana, United States
Missoula, Montana, United States
Brick, New Jersey, United States
Mineola, New York, United States
Rochester, New York, United States
High Point, North Carolina, United States
Sylvania, Ohio, United States
Lake Oswego, Oregon, United States
Rochester, Minnesota, United States
Scottsdale, Arizona, United States
Mission Viejo, California, United States
Napa, California, United States
Orange, California, United States
Sacramento, California, United States
San Diego, California, United States
Miami, Florida, United States
North Palm Beach, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Evansville, Indiana, United States
Iowa City, Iowa, United States
Crescent Springs, Kentucky, United States
Owensboro, Kentucky, United States
Wheaton, Maryland, United States
Altoona, Pennsylvania, United States
Blue Bell, Pennsylvania, United States
Hershey, Pennsylvania, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
South Burlington, Vermont, United States
Richmond, Virginia, United States
Canberra, Australian Capital Territory, Australia
Brisbane, Queensland, Australia
Carlton, Victoria, Australia
Melbourne, Victoria, Australia
Berlin, , Germany
Cologne, , Germany
Erlangen, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Lübeck, , Germany
Mainz, , Germany
Marburg, , Germany
Tübingen, , Germany
Auckland, , New Zealand
Beckenham, , New Zealand
Tauranga, , New Zealand
Wellington, , New Zealand
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Warsaw, , Poland
Singapore, , Singapore
Singapore, , Singapore
Aarau, , Switzerland
Bern, , Switzerland
Sankt Gallen, , Switzerland
Cambridge, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Norwich, , United Kingdom
Oxford, , United Kingdom
Sheffield, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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GA00889
Identifier Type: OTHER
Identifier Source: secondary_id
Q4883g
Identifier Type: -
Identifier Source: org_study_id