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Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

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ClinicalTrials.gov Identifier: NCT02329223
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : September 20, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This was a 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 participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Uriticaria Biological: Omalizumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Omalizumab 300 mg
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
Biological: Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Other Name: Xolair

Experimental: Omalizumab 150 mg
Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
Biological: Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
Other Name: Xolair

Placebo Comparator: Placebo
Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
Other: Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.




Primary Outcome Measures :
  1. Change From Baseline in the Weekly Itch Severity Score at Week 12 [ Time Frame: Baseline to Week 12 ]
    The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. 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 from baseline indicates improvement.


Secondary Outcome Measures :
  1. Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 [ Time Frame: Baseline to Week 12 ]
    The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.

  2. Change From Baseline in the Weekly Number of Hives Score at Week 12 [ Time Frame: Baseline to 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.

  3. Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 [ Time Frame: Week 12 ]
    The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria 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 urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.

  4. Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 [ Time Frame: Baseline to Week 12 ]
    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 from baseline indicates a reduction in hive size.

  5. Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12 [ Time Frame: Week 12 ]
    Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.

  6. Percentage of Complete Responders (UAS7 = 0) at Week 12 [ Time Frame: Week 12 ]
    Complete responders are defined as participants who achieved UAS7 = 0.

  7. Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 [ Time Frame: Baseline to Week 12 ]
    The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants 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 from baseline indicates improvement.

  8. Percentage of Participants With Production of Anti-omalizumab Antibody [ Time Frame: Week 24 ]
    Serum samples were collected for anti-omalizumab antibody testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
  • Chronic spontaneous urticaria diagnosis for 6 months

Key Exclusion Criteria:

  • Weight less than 20 kg
  • Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
  • Evidence of parasitic infection
  • Any other skin diseases than chronic spontaneous urticaria with chronic itching
  • Previous treatment with omalizumab
  • Contraindications to diphenhydramine
  • History of anaphylactic shock
  • History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
  • History of hypersensitivity to omalizumab or to drugs of similar chemical classes
  • Pregnant or nursing (lactating) women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329223


Locations
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Japan
Novartis Investigative Site
Toyoake-city, Aichi, Japan, 470-1192
Novartis Investigative Site
Hiroshima-city, Hiroshima, Japan, 734-8551
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site
Nishinomiya-city, Hyogo, Japan, 663-8186
Novartis Investigative Site
Hitachi-city, Ibaraki, Japan, 317-0077
Novartis Investigative Site
Takamatsu-city, Kagawa, Japan, 760-0017
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 213-8507
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 221-0825
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 231-0868
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 236-0004
Novartis Investigative Site
Yokosuka-city, Kanagawa, Japan, 238-8558
Novartis Investigative Site
Kamimashi-gun, Kumamoto, Japan, 861-3101
Novartis Investigative Site
Nagano-city, Nagano, Japan, 381-8551
Novartis Investigative Site
Osaka-city, Osaka, Japan, 532-0003
Novartis Investigative Site
Sakai-city, Osaka, Japan, 593-8324
Novartis Investigative Site
Saitama-city, Saitama, Japan, 330-0854
Novartis Investigative Site
Izumo-city, Shimane, Japan, 693-8501
Novartis Investigative Site
Kodaira-city, Tokyo, Japan, 187-8510
Novartis Investigative Site
Machida-city, Tokyo, Japan, 194-0013
Novartis Investigative Site
Meguro-ku, Tokyo, Japan, 153-8515
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 107-6206
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 143-0023
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-8625
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 161-8521
Novartis Investigative Site
Kofu-city, Yamanashi, Japan, 400-8506
Korea, Republic of
Novartis Investigative Site
Wonju, Gangwon, Korea, Republic of, 220-701
Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, Korea, Republic of, 445-170
Novartis Investigative Site
Suwon, Gyeonggi-do, Korea, Republic of, 443-380
Novartis Investigative Site
Seongnam, Gyeonggi, Korea, Republic of, 13620
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 06591
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 152-703
Novartis Investigative Site
Busan, Korea, Republic of, 602-715
Novartis Investigative Site
Daegu, Korea, Republic of, 705-703
Novartis Investigative Site
Gwangju, Korea, Republic of, 501-757
Novartis Investigative Site
Incheon, Korea, Republic of, 405-760
Novartis Investigative Site
Seoul, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Republic of, 130-872
Novartis Investigative Site
Seoul, Korea, Republic of, 156-755
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02329223    
Other Study ID Numbers: CIGE025E2306
First Posted: December 31, 2014    Key Record Dates
Results First Posted: September 20, 2016
Last Update Posted: September 21, 2016
Last Verified: September 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic spontaneous uriticaria
Omalizumab
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents