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Trial details imported from ClinicalTrials.gov

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


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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Complete Hives Response (HSS7=0) - 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.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days - 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)
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 - 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)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
HSS7=0 Response: at Week 20 Measured Over 7 Days - 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)
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 - 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)
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 - 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)
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 - 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)
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 - UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
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 - UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
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 - 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.
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
UAS7=0 Response: at Week 20 Measured Over 7 Days - 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.
Timepoint [10] 0 0
Week 20
Secondary outcome [11] 0 0
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days - 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)
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
ISS7=0 Response: at Week 20 Measured Over 7 Days - 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)
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
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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
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
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
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
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
Country [30] 0 0
Greece
State/province [30] 0 0
Haidari Athens
Country [31] 0 0
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
Country [36] 0 0
Japan
State/province [36] 0 0
Kyoto
Country [37] 0 0
Japan
State/province [37] 0 0
Osaka
Country [38] 0 0
Japan
State/province [38] 0 0
Saitama
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Tatarstan Republic
Country [41] 0 0
Russian Federation
State/province [41] 0 0
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
State/province [50] 0 0
Comunidad Valenciana
Country [51] 0 0
Spain
State/province [51] 0 0
Galicia
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Taiwan
State/province [53] 0 0
Taichung
Country [54] 0 0
Taiwan
State/province [54] 0 0
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
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/show/NCT02477332
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

Summary results
Other publications