Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Launched by NOVARTIS PHARMACEUTICALS · Dec 29, 2014
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, Korea, Korea, Republic Of
Shinagawa Ku, Tokyo, Japan
Daegu, , Korea, Republic Of
Suwon, Gyeonggi Do, Korea, Republic Of
Hiroshima City, Hiroshima, Japan
Seongnam, Gyeonggi, Korea, Republic Of
Busan, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Incheon, , Korea, Republic Of
Saitama City, Saitama, Japan
Ota Ku, Tokyo, Japan
Kobe City, Hyogo, Japan
Wonju, Gangwon, Korea, Republic Of
Toyoake City, Aichi, Japan
Yokosuka City, Kanagawa, Japan
Hitachi City, Ibaraki, Japan
Kawasaki City, Kanagawa, Japan
Kofu City, Yamanashi, Japan
Nishinomiya City, Hyogo, Japan
Takamatsu City, Kagawa, Japan
Yokohama City, Kanagawa, Japan
Kamimashi Gun, Kumamoto, Japan
Nagano City, Nagano, Japan
Osaka City, Osaka, Japan
Sakai City, Osaka, Japan
Izumo City, Shimane, Japan
Kodaira City, Tokyo, Japan
Machida City, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Hwaseong Si, Gyeonggi Do, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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