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Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

NCT ID: NCT02477332

Last Updated: 2021-01-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-15

Study Completion Date

2017-06-12

Brief Summary

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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.

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Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)

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Detailed Description

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Conditions

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Chronic Spontaneous Urticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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QGE031 24 mg s.c. q4w

ligelizumab 24 mg injection subcutaneous every 4 weeks

Group Type EXPERIMENTAL

QGE031

Intervention Type BIOLOGICAL

QGE031 72 mg s.c. q4w

ligelizumab 72 mg injection subcutaneous every 4 weeks

Group Type EXPERIMENTAL

QGE031

Intervention Type BIOLOGICAL

QGE031 240 mg s.c. q4w

ligelizumab 240 mg injection subcutaneous every 4 weeks

Group Type EXPERIMENTAL

QGE031

Intervention Type BIOLOGICAL

Omalizumab 300 mg s.c. q4w

omalizumab 300 mg injection subcutaneous every 4 weeks

Group Type ACTIVE_COMPARATOR

Omalizumab

Intervention Type BIOLOGICAL

Placebo s.c. q4w

placebo injection subcutaneous every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

QGE031 120 mg s.c. s.d.

ligelizumab 120 mg injection subcutaneous single dose

Group Type EXPERIMENTAL

QGE031

Intervention Type BIOLOGICAL

Interventions

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QGE031

Intervention Type BIOLOGICAL

Omalizumab

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of chronic spontaneous urticaria for at least 6 months
* Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Machida, Tokyo, Japan

Site Status

Novartis Investigative Site

Ōta-ku, Tokyo, Japan

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Shinagawa-ku, Tokyo, Japan

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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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Huntington Beach, California, United States

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Mission Viejo, California, United States

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Sarasota, Florida, United States

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Evansville, Indiana, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Waldorf, Maryland, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Forest Hills, New York, United States

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The Bronx, New York, 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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Katy, Texas, United States

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South Burlington, Vermont, United States

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Spokane, Washington, 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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Haidari Athens, Greece, Greece

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Athens, GR, Greece

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Athens, , Greece

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Hiroshima, Hiroshima, Japan

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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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Kazan', Tatarstan Republic, Russia

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Chelyabinsk, , Russia

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Moscow, , 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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Sant Joan Despí, Barcelona, 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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A Coruña, Galicia, Spain

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Alcorcón, Madrid, Spain

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Pozuelo de Alarcón, 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

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Leeds, , United Kingdom

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London, , United Kingdom

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Countries

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United States Australia Canada Germany Greece Japan Russia Spain Taiwan United Kingdom

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.

Reference Type DERIVED
PMID: 36440464 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34773261 (View on PubMed)

Maurer 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.

Reference Type DERIVED
PMID: 31577874 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=364

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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2014-005559-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQGE031C2201

Identifier Type: -

Identifier Source: org_study_id

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