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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
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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
0
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0
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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
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
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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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - 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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - 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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - 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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - 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
1. - Mild (1-6 hives/12 hours)
2. - Moderate (7-12 hives/12 hours)
3. - 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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - 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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - 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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - 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
1. - Mild (minimal awareness, easily tolerated)
2. - Moderate (definite awareness, bothersome but tolerable)
3. - 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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Leeds
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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/study/NCT02477332
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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.
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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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Phone
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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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
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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 not provided in
https://clinicaltrials.gov/study/NCT02477332