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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/NCT02649218




Registration number
NCT02649218
Ethics application status
Date submitted
15/12/2015
Date registered
7/01/2016
Date last updated
11/10/2021

Titles & IDs
Public title
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
Scientific title
An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria Patients Who Completed Study CQGE031C2201
Secondary ID [1] 0 0
2015-003636-13
Secondary ID [2] 0 0
CQGE031C2201E1
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 - Ligelizumab

Experimental: Ligelizumab - QGE031 240 mg s.c. q4w x 13 treatments


Other interventions: Ligelizumab
QGE031 240 mg s.c. q4w
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
Timepoint [1] 0 0
Within 16 weeks after Week 48
Secondary outcome [1] 0 0
Percentage of Subjects Having Achieved UAS7 = 6
Timepoint [1] 0 0
Baseline, Week 52 and Week 100
Secondary outcome [2] 0 0
Number and Proportion of Participants Who Achieved UAS7= 6
Timepoint [2] 0 0
Baseline, Week 52, Week 100

Eligibility
Key inclusion criteria
- Patients eligible for inclusion in this study have to fulfill all of the following
criteria:

1. Written informed consent must be obtained before any assessment is performed.

2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at
least Visit 203 (Week 32 of the follow-up epoch, =16 weeks after last injection)
and present with active disease as defined by UAS7 =12.

3. Patients must not have any missing eDiary entries in the 7 days prior to Visit
301 (patients are allowed to repeat until this criterion is met).

4. Willing and able to complete a daily symptom eDiary for the duration of the study
and adhere to the study visit schedules.
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 diseases than chronic spontaneous urticaria with chronic itching

- 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
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
24/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/05/2019
Sample size
Target
Accrual to date
Final
226
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Vermont
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Freiburg
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Germany
State/province [22] 0 0
Hannover
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Germany
State/province [23] 0 0
Mainz
Country [24] 0 0
Germany
State/province [24] 0 0
Muenster
Country [25] 0 0
Greece
State/province [25] 0 0
GR
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Greece
State/province [26] 0 0
Athens
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Japan
State/province [27] 0 0
Hokkaido
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Japan
State/province [28] 0 0
Hyogo
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Kumamoto
Country [31] 0 0
Japan
State/province [31] 0 0
Kyoto
Country [32] 0 0
Japan
State/province [32] 0 0
Osaka
Country [33] 0 0
Japan
State/province [33] 0 0
Saitama
Country [34] 0 0
Japan
State/province [34] 0 0
Tokyo
Country [35] 0 0
Japan
State/province [35] 0 0
Hiroshima
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Chelyabinsk
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Smolensk
Country [39] 0 0
Russian Federation
State/province [39] 0 0
St Petersburg
Country [40] 0 0
Russian Federation
State/province [40] 0 0
St.-Petersburg
Country [41] 0 0
Spain
State/province [41] 0 0
Andalucia
Country [42] 0 0
Spain
State/province [42] 0 0
Cataluna
Country [43] 0 0
Spain
State/province [43] 0 0
Catalunya
Country [44] 0 0
Spain
State/province [44] 0 0
Comunidad Valenciana
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taichung
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Tao Yuan
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Somerset

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4
weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study
CQGE031C2201
Trial website
https://clinicaltrials.gov/ct2/show/NCT02649218
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02649218