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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02649218




Registration number
NCT02649218
Ethics application status
Date submitted
15/12/2015
Date registered
7/01/2016

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
Treatment: Other - Ligelizumab

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


Treatment: Other: Ligelizumab
QGE031 240 mg s.c. q4w
Intervention code [1] 0 0
Treatment: Other
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
NA
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
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United States of America
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Arizona
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United States of America
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Arkansas
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Florida
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Indiana
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Kentucky
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Maryland
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Minnesota
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Missouri
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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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United States of America
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Texas
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United States of America
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Vermont
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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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Japan
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Hokkaido
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Hyogo
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Japan
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Kanagawa
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Kumamoto
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Kyoto
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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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Japan
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Hiroshima
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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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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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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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Madrid
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Spain
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Barcelona
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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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02649218