A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201
2 other identifiers
interventional
226
10 countries
67
Brief Summary
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Typical duration for phase_2
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedStudy Start
First participant enrolled
May 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2019
CompletedResults Posted
Study results publicly available
August 14, 2020
CompletedOctober 11, 2021
October 1, 2021
2.9 years
December 15, 2015
April 28, 2020
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.
Within 16 weeks after Week 48
Secondary Outcomes (2)
Percentage of Subjects Having Achieved UAS7 ≤ 6
Baseline, Week 52 and Week 100
Number and Proportion of Participants Who Achieved UAS7≤ 6
Baseline, Week 52, Week 100
Study Arms (1)
Ligelizumab
EXPERIMENTALQGE031 240 mg s.c. q4w x 13 treatments
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained before any assessment is performed.
- 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.
- 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).
- Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Novartis Investigative Site
Birmingham, Alabama, 35209, United States
Novartis Investigative Site
Scottsdale, Arizona, 85251, United States
Novartis Investigative Site
Little Rock, Arkansas, 72205, United States
Novartis Investigative Site
Sarasota, Florida, 34233, United States
Novartis Investigative Site
Evansville, Indiana, 47713, United States
Novartis Investigative Site
Owensboro, Kentucky, 42301, United States
Novartis Investigative Site
Waldorf, Maryland, 20602, United States
Novartis Investigative Site
Rochester, Minnesota, 55905, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Asheville, North Carolina, 28801, United States
Novartis Investigative Site
Cincinnati, Ohio, 45231, United States
Novartis Investigative Site
Toledo, Ohio, 43617, United States
Novartis Investigative Site
Lake Oswego, Oregon, 97035, United States
Novartis Investigative Site
Providence, Rhode Island, 02906, United States
Novartis Investigative Site
Dallas, Texas, 75230, United States
Novartis Investigative Site
Fort Worth, Texas, 76132, United States
Novartis Investigative Site
South Burlington, Vermont, 05403, United States
Novartis Investigative Site
Campbelltown, New South Wales, 2560, Australia
Novartis Investigative Site
Sydney, New South Wales, 2010, Australia
Novartis Investigative Site
Woolloongabba, Queensland, 4102, Australia
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
Novartis Investigative Site
East Melbourne, Victoria, 3002, Australia
Novartis Investigative Site
Toronto, Ontario, M4V 1R2, Canada
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4, Canada
Novartis Investigative Site
Québec, G1V 4W2, Canada
Novartis Investigative Site
Munich, Bavaria, 80377, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Münster, 48149, Germany
Novartis Investigative Site
Athens, GR, 115 27, Greece
Novartis Investigative Site
Athens, 115 27, Greece
Novartis Investigative Site
Athens, 12462, Greece
Novartis Investigative Site
Obihiro, Hokkaido, 080 0013, Japan
Novartis Investigative Site
Kobe, Hyōgo, 650-0017, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825, Japan
Novartis Investigative Site
Kamimashi-gun, Kumamoto, 861-3101, Japan
Novartis Investigative Site
Kyoto, Kyoto, 602-8566, Japan
Novartis Investigative Site
Sakai, Osaka, 593-8324, Japan
Novartis Investigative Site
Saitama, Saitama, 330-0854, Japan
Novartis Investigative Site
Machida, Tokyo, 194-0013, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023, Japan
Novartis Investigative Site
Shinagawa Ku, Tokyo, 141 8625, Japan
Novartis Investigative Site
Hiroshima, 734-8551, Japan
Novartis Investigative Site
Chelyabinsk, 454092, Russia
Novartis Investigative Site
Moscow, 115478, Russia
Novartis Investigative Site
Saint Petersburg, 194223, Russia
Novartis Investigative Site
Saint Petersburg, 195112, Russia
Novartis Investigative Site
Smolensk, 214019, Russia
Novartis Investigative Site
Córdoba, Andalusia, 14004, Spain
Novartis Investigative Site
Málaga, Andalusia, 29009, Spain
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08003, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08036, Spain
Novartis Investigative Site
Alcorcón, Madrid, 28922, Spain
Novartis Investigative Site
Alicante, Valencia, 03010, Spain
Novartis Investigative Site
Valencia, Valencia, 46015, Spain
Novartis Investigative Site
Barcelona, 08041, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Madrid, 28041, Spain
Novartis Investigative Site
Taoyuan District, Taiwan, 333, Taiwan
Novartis Investigative Site
Taichung, 407, Taiwan
Novartis Investigative Site
Taipei, 10002, Taiwan
Novartis Investigative Site
Yeovil, Somerset, BA21 4AT, United Kingdom
Related Publications (2)
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.
PMID: 36440464DERIVEDMaurer 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.
PMID: 34773261DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Lead
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
January 7, 2016
Study Start
May 24, 2016
Primary Completion
May 2, 2019
Study Completion
May 2, 2019
Last Updated
October 11, 2021
Results First Posted
August 14, 2020
Record last verified: 2021-10