Clinical trial NCT02477332: Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Keywords: QGE031
ligelizumab
omalizumab
chronic
spontaneous
urticaria
adults
CSU
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Complete Hives Response (HSS7=0)
timeFrame: Week 12
Secondary outcomes:
measure: Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
timeFrame: Week 12
measure: Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
timeFrame: Week 12
measure: HSS7=0 Response: at Week 20 Measured Over 7 Days
timeFrame: Week 20
measure: Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
timeFrame: Week 20
measure: Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
timeFrame: Week 12
measure: Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
timeFrame: Week 20
measure: Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
timeFrame: Week 12
measure: Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
timeFrame: Week 20
measure: Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
timeFrame: Week 12
measure: UAS7=0 Response: at Week 20 Measured Over 7 Days
timeFrame: Week 20
measure: Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
timeFrame: Week 12
measure: ISS7=0 Response: at Week 20 Measured Over 7 Days
timeFrame: Week 20
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Scottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Mission Viejo
country: United States
facility: Novartis Investigative Site
state: California
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Owensboro
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Waldorf
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Forest Hills
country: United States
facility: Novartis Investigative Site
state: New York
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Lake Oswego
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Providence
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigative Site
state: Texas
city: Katy
country: United States
facility: Novartis Investigative Site
state: Texas
city: South Burlington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Campbelltown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: East Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Haidari Athens
country: Greece
facility: Novartis Investigative Site
city: Hiroshima city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Obihiro-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kamimashi-gun
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Sakai
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Saitama-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Machida-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
state: Tatarstan Republic
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sant Joan Despi
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Alcorcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Tao-Yuan
country: Taiwan
facility: Novartis Investigative Site
city: Yeovil
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.