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Search / Trial NCT02329223

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 05, 2025

Completed

Keywords

Chronic Spontaneous Uriticaria Omalizumab

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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