Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)
2 other identifiers
interventional
382
10 countries
82
Brief Summary
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
82 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
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 22, 2015
CompletedStudy Start
First participant enrolled
July 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2017
CompletedResults Posted
Study results publicly available
September 14, 2018
CompletedJanuary 5, 2021
October 1, 2018
1.3 years
June 11, 2015
June 5, 2018
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Complete Hives Response (HSS7=0)
The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
Week 12
Secondary Outcomes (12)
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
Week 12
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
Week 12
HSS7=0 Response: at Week 20 Measured Over 7 Days
Week 20
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
Week 20
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
Week 12
- +7 more secondary outcomes
Study Arms (6)
QGE031 24 mg s.c. q4w
EXPERIMENTALligelizumab 24 mg injection subcutaneous every 4 weeks
QGE031 72 mg s.c. q4w
EXPERIMENTALligelizumab 72 mg injection subcutaneous every 4 weeks
QGE031 240 mg s.c. q4w
EXPERIMENTALligelizumab 240 mg injection subcutaneous every 4 weeks
Omalizumab 300 mg s.c. q4w
ACTIVE COMPARATORomalizumab 300 mg injection subcutaneous every 4 weeks
Placebo s.c. q4w
PLACEBO COMPARATORplacebo injection subcutaneous every 4 weeks
QGE031 120 mg s.c. s.d.
EXPERIMENTALligelizumab 120 mg injection subcutaneous single dose
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic spontaneous urticaria for at least 6 months
- Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
You may not qualify if:
- Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
- Evidence of parasitic infection
- Any other skin disease with chronic itching
- Previous treatment with omalizumab or QGE031
- 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
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
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
Huntington Beach, California, 92647, United States
Novartis Investigative Site
Mission Viejo, California, 92691, United States
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Sarasota, Florida, 34233, United States
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Evansville, Indiana, 47713, United States
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Louisville, Kentucky, 40291, United States
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Owensboro, Kentucky, 42301, United States
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Waldorf, Maryland, 20602, United States
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Minneapolis, Minnesota, 55402, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63141, United States
Novartis Investigative Site
Forest Hills, New York, 11375, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28801, United States
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Cincinnati, Ohio, 45231, United States
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Toledo, Ohio, 43617, United States
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Lake Oswego, Oregon, 97035, United States
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Providence, Rhode Island, 02906, United States
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Dallas, Texas, 75230, United States
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Fort Worth, Texas, 76132, United States
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Katy, Texas, 77450, United States
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South Burlington, Vermont, 05403, United States
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Spokane, Washington, 99204, United States
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Campbelltown, New South Wales, 2560, Australia
Novartis Investigative Site
Sydney, New South Wales, 2010, Australia
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Woolloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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East Melbourne, Victoria, 3002, Australia
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Toronto, Ontario, M4V 1R2, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Québec, G1V 4W2, Canada
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Munich, Bavaria, 80802, Germany
Novartis Investigative Site
Berlin, 10117, Germany
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Dresden, 01307, Germany
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Freiburg im Breisgau, 79106, Germany
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Hanover, 30625, Germany
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Mainz, 55131, Germany
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Münster, 48149, Germany
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Haidari Athens, Greece, 12462, Greece
Novartis Investigative Site
Athens, GR, 115 27, Greece
Novartis Investigative Site
Athens, 11527, Greece
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Hiroshima, Hiroshima, 734-8551, Japan
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
Kazan', Tatarstan Republic, 420012, Russia
Novartis Investigative Site
Chelyabinsk, 454092, Russia
Novartis Investigative Site
Moscow, 107076, 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
Sant Joan Despí, Barcelona, 08970, 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
A Coruña, Galicia, 15006, Spain
Novartis Investigative Site
Alcorcón, Madrid, 28922, Spain
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223, 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
Novartis Investigative Site
Leeds, LS9 7TF, United Kingdom
Novartis Investigative Site
London, SE1 9RT, United Kingdom
Related Publications (3)
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: 34773261DERIVEDMaurer M, Gimenez-Arnau AM, Sussman G, Metz M, Baker DR, Bauer A, Bernstein JA, Brehler R, Chu CY, Chung WH, Danilycheva I, Grattan C, Hebert J, Katelaris C, Makris M, Meshkova R, Savic S, Sinclair R, Sitz K, Staubach P, Wedi B, Loffler J, Barve A, Kobayashi K, Hua E, Severin T, Janocha R. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019 Oct 3;381(14):1321-1332. doi: 10.1056/NEJMoa1900408.
PMID: 31577874DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure Office
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 22, 2015
Study Start
July 15, 2015
Primary Completion
November 2, 2016
Study Completion
June 12, 2017
Last Updated
January 5, 2021
Results First Posted
September 14, 2018
Record last verified: 2018-10