Trial from ClinicalTrials.gov

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Trial ID
NCT02477332
Ethics application status
Date submitted
11/06/2015
Date registered
11/06/2015
Date last updated
2/08/2017

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - QGE031
Other interventions - Omalizumab
Other interventions - Placebo

Experimental: QGE031 Arm 1 -

Experimental: QGE031 Arm 2 -

Experimental: QGE031 Arm 3 -

Experimental: QGE031 Arm 4 -

Active Comparator: Omalizumab -

Placebo Comparator: Placebo -


Other interventions: QGE031


Other interventions: Omalizumab


Other interventions: Placebo


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete hives response (HSS7=0) - Complete hives response is defined as Hives Severity Score (HSS7) of 0.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Complete hives response (HSS7=0) compared with omalizumab - Complete hives response is defined as Hives Severity Score (HSS7=0)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Complete hives response (HSS7=0) of individual QGE031 doses compared with omalizumab - Complete hives response is defined as Hives Severity Score (HSS7) of 0.
Timepoint [2] 0 0
Week 20
Secondary outcome [3] 0 0
Change from baseline in hives severity score (HSS7)
Timepoint [3] 0 0
Baseline, Week 12 and Week 20
Secondary outcome [4] 0 0
Change from baseline in itch severity score (ISS7)
Timepoint [4] 0 0
Baseline, Week 12, and Week 20
Secondary outcome [5] 0 0
Change from baseline in urticaria severity score (UAS7)
Timepoint [5] 0 0
Baseline, Week 12 and Week 20
Secondary outcome [6] 0 0
Number of participants with adverse events as a measure of safety and tolerability
Timepoint [6] 0 0
Week 20 and Week 44

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
Gender
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 diseases than chronic spontaneous urticaria with chronic itching

- Previous treatment with omalizumab or QGE031

- Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
epinephrine

- History of anaphylactic shock

- 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
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
State/province [5] 0 0
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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Nebraska
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New Jersey
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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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United States of America
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Vermont
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United States of America
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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
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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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Ishikawa
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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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Saint-Petersburg
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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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Spain
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Navarra
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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
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London
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United Kingdom
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Newcastle Upon Tyne

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
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
Contact person responsible for updating information