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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02477332




Registration number
NCT02477332
Ethics application status
Date submitted
11/06/2015
Date registered
22/06/2015
Date last updated
5/01/2021

Titles & IDs
Public title
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Scientific 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)
Secondary ID [1] 0 0
2014-005559-16
Secondary ID [2] 0 0
CQGE031C2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: QGE031 24 mg s.c. q4w - ligelizumab 24 mg injection subcutaneous every 4 weeks

Experimental: QGE031 72 mg s.c. q4w - ligelizumab 72 mg injection subcutaneous every 4 weeks

Experimental: QGE031 240 mg s.c. q4w - ligelizumab 240 mg injection subcutaneous every 4 weeks

Active comparator: Omalizumab 300 mg s.c. q4w - omalizumab 300 mg injection subcutaneous every 4 weeks

Placebo comparator: Placebo s.c. q4w - placebo injection subcutaneous every 4 weeks

Experimental: QGE031 120 mg s.c. s.d. - ligelizumab 120 mg injection subcutaneous single dose
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Complete Hives Response (HSS7=0)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
HSS7=0 Response: at Week 20 Measured Over 7 Days
Timepoint [3] 0 0
Week 20
Secondary outcome [4] 0 0
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
Timepoint [4] 0 0
Week 20
Secondary outcome [5] 0 0
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
Timepoint [6] 0 0
Week 20
Secondary outcome [7] 0 0
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
Timepoint [8] 0 0
Week 20
Secondary outcome [9] 0 0
Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
UAS7=0 Response: at Week 20 Measured Over 7 Days
Timepoint [10] 0 0
Week 20
Secondary outcome [11] 0 0
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
ISS7=0 Response: at Week 20 Measured Over 7 Days
Timepoint [12] 0 0
Week 20

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/06/2017
Sample size
Target
Accrual to date
Final
382
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Campbelltown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [3] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [4] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [5] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Maryland
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Rhode Island
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Texas
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Vermont
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Washington
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Canada
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Ontario
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Canada
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Quebec
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Germany
State/province [21] 0 0
Bayern
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Freiburg
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Germany
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Hannover
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Germany
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Mainz
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Germany
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Muenster
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Greece
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GR
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Greece
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Athens
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Greece
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Haidari Athens
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Russian Federation
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Tatarstan Republic
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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St.-Petersburg
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Cataluna
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Madrid
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Tao-Yuan
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United Kingdom
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Somerset
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United Kingdom
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Leeds
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United Kingdom
State/province [58] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02477332
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02477332