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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

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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
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Minnesota
Country [10] 0 0
United States of America
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Missouri
Country [11] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [14] 0 0
United States of America
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Oregon
Country [15] 0 0
United States of America
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Rhode Island
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United States of America
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Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Vermont
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Germany
State/province [21] 0 0
Bayern
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Dresden
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Mainz
Country [27] 0 0
Germany
State/province [27] 0 0
Muenster
Country [28] 0 0
Greece
State/province [28] 0 0
GR
Country [29] 0 0
Greece
State/province [29] 0 0
Athens
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Greece
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Haidari Athens
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Japan
State/province [31] 0 0
Hiroshima
Country [32] 0 0
Japan
State/province [32] 0 0
Hokkaido
Country [33] 0 0
Japan
State/province [33] 0 0
Hyogo
Country [34] 0 0
Japan
State/province [34] 0 0
Kanagawa
Country [35] 0 0
Japan
State/province [35] 0 0
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
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Tatarstan Republic
Country [41] 0 0
Russian Federation
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Chelyabinsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Smolensk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
St Petersburg
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St.-Petersburg
Country [46] 0 0
Spain
State/province [46] 0 0
Andalucia
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Cataluna
Country [49] 0 0
Spain
State/province [49] 0 0
Catalunya
Country [50] 0 0
Spain
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Comunidad Valenciana
Country [51] 0 0
Spain
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Galicia
Country [52] 0 0
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
Country [55] 0 0
Taiwan
State/province [55] 0 0
Tao-Yuan
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Somerset
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Leeds
Country [58] 0 0
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02477332