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This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | Participants will receive open-label omalizumab treatment at 300 mg SC Q4W for 24 weeks. After 24 weeks open-label treatment, eligible participants will be randomized to receive omalizumab treatment at 300 mg SC Q4W for next 24 weeks (up to Week 48). Participants randomized to omalizumab may, at the discretion of the investigator, be transitioned from blinded study drug to open-label omalizumab at 300 mg SC Q4W if they experience clinically significant worsening in their CIU (as judged by the investigator). Participants who are transitioned to open-label omalizumab will continue to receive open-label omalizumab as study drug until Week 48. |
|
| Placebo | Placebo Comparator | Participants will receive open-label omalizumab treatment at 300 mg SC Q4W for 24 weeks. After 24 weeks open-label treatment, eligible participants will be randomized to receive placebo SC Q4W for next 24 weeks (up to Week 48). Participants randomized to placebo may, at the discretion of the investigator, be transitioned from blinded study drug to open-label omalizumab at 300 mg SC Q4W if they experience clinically significant worsening in their CIU (as judged by the investigator). Participants who are transitioned to open-label omalizumab will continue to receive open-label omalizumab as study drug until Week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | Omalizumab 300 mg administered SC Q4W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks) | Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48. | From randomization (Week 24) to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. |
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Inclusion Criteria:
Exclusion Criteria:
regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G or plasmapheresis
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy and Asthma Relief Experts | Granada Hills | California | 91344 | United States | ||
| Allergy & Asthma Care Center of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31034999 | Derived | Casale TB, Murphy TR, Holden M, Rajput Y, Yoo B, Bernstein JA. Impact of omalizumab on patient-reported outcomes in chronic idiopathic urticaria: Results from a randomized study (XTEND-CIU). J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2487-2490.e1. doi: 10.1016/j.jaip.2019.04.020. Epub 2019 Apr 26. No abstract available. |
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A total of 206 participants were enrolled in the study, but only 205 participants received at least one dose of any study treatment. Results include only the treated 205 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab (Non-Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 milligrams (mg) via subcutaneous (SC) injection every 4 weeks (Q4W) for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2016 | Feb 21, 2018 |
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| Placebo | Drug | Placebo matched to omalizumab administered SC Q4W. |
|
| From randomization (Week 24) to Week 48 |
| Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48. | From randomization (Week 24) to Week 48 |
| Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score (Week 48 score minus Week 24 score) indicates improvement. | Week 24 (randomization) and Week 48 |
| Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score indicates improvement. | At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60) |
| Long Beach |
| California |
| 90808 |
| United States |
| Dermatology Research Associate | Los Angeles | California | 90045 | United States |
| Southern California Research Center | Mission Viejo | California | 92691 | United States |
| Choc Psf, Amc | Orange | California | 92868 | United States |
| Allergy & Asthma Consultants | Redwood City | California | 94063 | United States |
| Allergy and Asthma Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| Colorado Allergy & Asthma Centers, Pc | Denver | Colorado | 80230 | United States |
| Florida Center for Allergy and Asthma Research | Aventura | Florida | 33180 | United States |
| Florida Ctr-Allergy & Asthma | Miami | Florida | 33173 | United States |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Clinical Research Center of Southern Illinois LLC | Shiloh | Illinois | 62269 | United States |
| Deaconess Clinic | Evansville | Indiana | 47713 | United States |
| Dawes Fretzin Clinical Res LLC | Indianapolis | Indiana | 46256 | United States |
| Abraham Research PLLC | Fort Mitchell | Kentucky | 41017 | United States |
| Dermatology Specialists Research, LLC | Louisville | Kentucky | 40241 | United States |
| Allergy & Asthma Specialists, PSC | Owensboro | Kentucky | 42301 | United States |
| Asthma, Allergy & Sinus Center | Baltimore | Maryland | 21236 | United States |
| Institute for Asthma & Allergy | Chevy Chase | Maryland | 20815 | United States |
| Respiratory Medicine Research; Institue of Michigan P.L.C. | Ypsilanti | Michigan | 48197 | United States |
| James Q. Del Rosso, DO, LLC | Las Vegas | Nevada | 89117 | United States |
| Ocean Allergy & Resp Res Ctr | Brick | New Jersey | 08724 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Aair Research Center | Rochester | New York | 14618 | United States |
| University of Rochester Medical Center; University Dermatology Associates | Rochester | New York | 14642 | United States |
| Montefiore Medical Group;Department of Medicine | The Bronx | New York | 10461 | United States |
| Allergy Partners of Western NC | Asheville | North Carolina | 28801 | United States |
| Allergy & Respiratory Center | Canton | Ohio | 44718 | United States |
| Bernstein Clinical Research Center Llc | Cincinnati | Ohio | 45231 | United States |
| Toledo Inst of Clin Research | Toledo | Ohio | 43617 | United States |
| Vital Prospects Clin Res Pc | Tulsa | Oklahoma | 74136 | United States |
| Asthma, Nasal Disease, and Allergy Research Center of New England | East Providence | Rhode Island | 02914 | United States |
| National Allergy and Asthma Research | Charleston | South Carolina | 29407 | United States |
| Live Oak Allergy & Asthma Clinic | Live Oak | Texas | 78233 | United States |
| Allergy & Asthma Research Center | San Antonio | Texas | 78229 | United States |
| Timber Lane Allergy-Asth Res | South Burlington | Vermont | 05403 | United States |
| O & O Alpan, LLC | Fairfax | Virginia | 22030 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Omalizumab (Randomized Participants) |
Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their chronic idiopathic urticaria (CIU) (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. |
| FG002 | Placebo (Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety evaluable population included all participants who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab (Non-Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit). |
| BG001 | Omalizumab (Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. |
| BG002 | Placebo (Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks) | Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48. | Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of blinded study drug, and achieved one post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization (Week 24) to Week 48 |
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| Secondary | Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley. | Analysis was performed on mITT population. | Posted | Median | 95% Confidence Interval | weeks | From randomization (Week 24) to Week 48 |
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| Secondary | Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48. | Analysis was performed on mITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization (Week 24) to Week 48 |
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| Secondary | Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score (Week 48 score minus Week 24 score) indicates improvement. | Analysis was performed on participants in mITT population who received total 48 weeks of treatment with omalizumab. If UAS7 data was missing, last observation carry forward (LOCF) method was used post-Week 24 for the closest non-missing UAS7 data up to Week 48. | Posted | Mean | Standard Deviation | units on a scale | Week 24 (randomization) and Week 48 |
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| Secondary | Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score indicates improvement. | Analysis was performed on participants in mITT population who were randomized to placebo arm and who were retreated with open-label omalizumab after randomization. Here, 'Number Analyzed' signifies number of participants with available data for this outcome at specified time-point. | Posted | Mean | Standard Deviation | units on a scale | At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60) |
|
From start of study drug until 112 days (approximately 5 drug half-lives) after the last dose of study drug or study discontinuation/termination, whichever is later (up to Week 64)
Analysis was performed on safety evaluable population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omalizumab (Non-Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After Week 24, participants did not receive any treatment and only returned for a final follow-up visit (12 weeks after Week 24 visit). | 0 | 71 | 0 | 71 | 22 | 71 |
| EG001 | Omalizumab (Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with omalizumab 300 mg via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. | 0 | 81 | 2 | 81 | 28 | 81 |
| EG002 | Placebo (Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. | 0 | 53 | 3 | 53 | 22 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Chronic spontaneous urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment | The participants at risk for this sex-specific adverse event were male participants and not all participants. |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2017 | Feb 21, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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| Race: Asian |
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| Race: Black or African American |
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| Race: White |
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| Race: Mixed/Unknown |
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| Ethnicity: Hispanic or Latino |
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| Ethnicity: Not Hispanic or Latino |
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| Ethnicity: Unknown |
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| OG001 | Placebo (Randomized Participants) | Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. |
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Participants received open-label omalizumab treatment at a dose of 300 mg via SC injection Q4W for 24 weeks. After 24 weeks of open-label treatment, participants received randomized treatment with placebo matching to omalizumab via SC injection Q4W for a further 24 weeks (up to Week 48). Participants, at the discretion of the investigator, could have been transitioned from blinded study drug to open-label omalizumab at a dose of 300 mg via SC injection Q4W if they experienced clinically significant worsening in their CIU (as judged by the investigator). Participants who were transitioned to open-label omalizumab continued to receive open-label omalizumab until Week 48. |
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