A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
NCT ID: NCT02649218
Last Updated: 2021-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2016-05-24
2019-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ligelizumab
QGE031 240 mg s.c. q4w x 13 treatments
Ligelizumab
QGE031 240 mg s.c. q4w
Interventions
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Ligelizumab
QGE031 240 mg s.c. q4w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Written informed consent must be obtained before any assessment is performed.
2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥12.
3. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
Exclusion Criteria
* Evidence of parasitic infection
* Any other skin diseases than chronic spontaneous urticaria with chronic itching
* Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
* History of anaphylaxis
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
* History of hypersensitivity to any of the study drugs or its components of similar chemical classes
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Sarasota, Florida, United States
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Evansville, Indiana, United States
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Owensboro, Kentucky, United States
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Waldorf, Maryland, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Asheville, North Carolina, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Lake Oswego, Oregon, United States
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Providence, Rhode Island, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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South Burlington, Vermont, United States
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Campbelltown, New South Wales, Australia
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Sydney, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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East Melbourne, Victoria, Australia
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Québec, , Canada
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Munich, Bavaria, Germany
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Berlin, , Germany
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Dresden, , Germany
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Freiburg im Breisgau, , Germany
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Hanover, , Germany
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Mainz, , Germany
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Münster, , Germany
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Athens, GR, Greece
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Athens, , Greece
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Athens, , Greece
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Obihiro, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Yokohama, Kanagawa, Japan
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Kamimashi-gun, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Sakai, Osaka, Japan
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Saitama, Saitama, Japan
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Machida, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Shinagawa Ku, Tokyo, Japan
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Hiroshima, , Japan
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Córdoba, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Alcorcón, Madrid, Spain
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Taoyuan District, Taiwan, Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Yeovil, Somerset, United Kingdom
Countries
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References
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Metz M, Bernstein JA, Gimenez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. doi: 10.1016/j.waojou.2022.100716. eCollection 2022 Nov.
Maurer M, Gimenez-Arnau A, Bernstein JA, Chu CY, Danilycheva I, Hide M, Makris M, Metz M, Savic S, Sitz K, Soong W, Staubach P, Sussman G, Barve A, Burciu A, Hua E, Janocha R, Severin T. Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. Allergy. 2022 Jul;77(7):2175-2184. doi: 10.1111/all.15175. Epub 2021 Nov 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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2015-003636-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQGE031C2201E1
Identifier Type: -
Identifier Source: org_study_id
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