Chronic Spontaneous Uriticaria Clinical Trial
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
| Verified date | September 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry of Food and Drug Safety |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 218 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Novartis Investigative Site | Hiroshima-city | Hiroshima |
| Japan | Novartis Investigative Site | Hitachi-city | Ibaraki |
| Japan | Novartis Investigative Site | Izumo-city | Shimane |
| Japan | Novartis Investigative Site | Kamimashi-gun | Kumamoto |
| Japan | Novartis Investigative Site | Kawasaki-city | Kanagawa |
| Japan | Novartis Investigative Site | Kobe-city | Hyogo |
| Japan | Novartis Investigative Site | Kodaira-city | Tokyo |
| Japan | Novartis Investigative Site | Kofu-city | Yamanashi |
| Japan | Novartis Investigative Site | Machida-city | Tokyo |
| Japan | Novartis Investigative Site | Meguro-ku | Tokyo |
| Japan | Novartis Investigative Site | Minato-ku | Tokyo |
| Japan | Novartis Investigative Site | Nagano-city | Nagano |
| Japan | Novartis Investigative Site | Nishinomiya-city | Hyogo |
| Japan | Novartis Investigative Site | Osaka-city | Osaka |
| Japan | Novartis Investigative Site | Ota-ku | Tokyo |
| Japan | Novartis Investigative Site | Saitama-city | Saitama |
| Japan | Novartis Investigative Site | Sakai-city | Osaka |
| Japan | Novartis Investigative Site | Shinagawa-ku | Tokyo |
| Japan | Novartis Investigative Site | Shinjuku-ku | Tokyo |
| Japan | Novartis Investigative Site | Takamatsu-city | Kagawa |
| Japan | Novartis Investigative Site | Toyoake-city | Aichi |
| Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
| Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
| Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
| Japan | Novartis Investigative Site | Yokosuka-city | Kanagawa |
| Korea, Republic of | Novartis Investigative Site | Busan | |
| Korea, Republic of | Novartis Investigative Site | Daegu | |
| Korea, Republic of | Novartis Investigative Site | Gwangju | |
| Korea, Republic of | Novartis Investigative Site | Hwaseong-si | Gyeonggi-do |
| Korea, Republic of | Novartis Investigative Site | Incheon | |
| Korea, Republic of | Novartis Investigative Site | Seongnam | Gyeonggi |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Suwon | Gyeonggi-do |
| Korea, Republic of | Novartis Investigative Site | Wonju | Gangwon |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Japan, Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in the Weekly Itch Severity Score at 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. | Baseline to Week 12 | No |
| Secondary | Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at 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. | Baseline to Week 12 | No |
| Secondary | 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. | Baseline to Week 12 | No |
| Secondary | Percentage of Participants With a UAS7 Score = 6 at 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. | Week 12 | No |
| Secondary | Change From Baseline in the Weekly Size of the Largest Hive Score at 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. | Baseline to Week 12 | No |
| Secondary | Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12 | Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of = 5 points. | Week 12 | No |
| Secondary | Percentage of Complete Responders (UAS7 = 0) at Week 12 | Complete responders are defined as participants who achieved UAS7 = 0. | Week 12 | No |
| Secondary | 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. 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. | Baseline to Week 12 | No |
| Secondary | Percentage of Participants With Production of Anti-omalizumab Antibody | Serum samples were collected for anti-omalizumab antibody testing. | Week 24 | Yes |