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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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2014-005559-16
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Secondary ID [2]
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CQGE031C2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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0
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Allergies
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - QGE031
Other interventions - Omalizumab
Other interventions - Placebo
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
Other interventions: QGE031
Other interventions: Omalizumab
Other interventions: Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Complete Hives Response (HSS7=0)
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Assessment method [1]
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The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).
Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.
Hives Severity Score scale:
0 - None
- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)
To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
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Assessment method [1]
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Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Complete hives response defined as HSS7 = 0.
Hives Severity Score scale:
0 - None
- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
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Assessment method [2]
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Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Hives Severity Score scale:
0 - None
- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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HSS7=0 Response: at Week 20 Measured Over 7 Days
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Assessment method [3]
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Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Complete hives response defined as HSS7 = 0.
Hives Severity Score scale:
0 - None
- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)
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Timepoint [3]
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Week 20
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Secondary outcome [4]
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Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
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Assessment method [4]
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Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Hives Severity Score scale:
0 - None
- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)
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Timepoint [4]
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Week 20
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Secondary outcome [5]
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Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
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Assessment method [5]
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Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Itch Severity Score scale:
0 - None
- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
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Assessment method [6]
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Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Itch Severity Score scale:
0 - None
- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)
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Timepoint [6]
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Week 20
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Secondary outcome [7]
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Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
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Assessment method [7]
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UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
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Assessment method [8]
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UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
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Timepoint [8]
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Week 20
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Secondary outcome [9]
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Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
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Assessment method [9]
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UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Complete urticaria activity response is defined as UAS7 = 0.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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UAS7=0 Response: at Week 20 Measured Over 7 Days
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Assessment method [10]
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UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Complete urticaria activity response is defined as UAS7 = 0.
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Timepoint [10]
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Week 20
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Secondary outcome [11]
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Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
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Assessment method [11]
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Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Complete itch response defined as ISS7 = 0.
Itch Severity Score scale:
0 - None
- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)
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Timepoint [11]
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Week 12
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Secondary outcome [12]
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ISS7=0 Response: at Week 20 Measured Over 7 Days
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Assessment method [12]
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Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.
Complete itch response defined as ISS7 = 0.
Itch Severity Score scale:
0 - None
- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)
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Timepoint [12]
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Week 20
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/06/2017
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Sample size
Target
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Accrual to date
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Final
382
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Campbelltown
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Recruitment hospital [2]
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Novartis Investigative Site - Sydney
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Recruitment hospital [3]
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Novartis Investigative Site - Woolloongabba
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Recruitment hospital [4]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [5]
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Novartis Investigative Site - East Melbourne
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Kentucky
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Maryland
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Missouri
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Bayern
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Kyoto
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Osaka
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Leeds
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02477332
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02477332
Download to PDF