A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Chronic Spontaneous Urticaria Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649218
• Other study ID #: CQGE031C2201E1
• Secondary ID: 2015-003636-13
• Status: Completed
• Phase: Phase 2
• Start date: May 24, 2016
• Est. completion date: May 2, 2019

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Biological:
• Ligelizumab
QGE031 240 mg s.c. q4w

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Campbelltown	New South Wales
Australia	Novartis Investigative Site	East Melbourne	Victoria
Australia	Novartis Investigative Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Woolloongabba	Queensland
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Muenchen	Bayern
Germany	Novartis Investigative Site	Muenster
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Kamimashi-gun	Kumamoto
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Machida-city	Tokyo
Japan	Novartis Investigative Site	Obihiro	Hokkaido
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Saitama-city	Saitama
Japan	Novartis Investigative Site	Sakai	Osaka
Japan	Novartis Investigative Site	Shinagawa ku	Tokyo
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St.-Petersburg
Spain	Novartis Investigative Site	Alcorcon	Madrid
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Tao Yuan
United Kingdom	Novartis Investigative Site	Yeovil	Somerset
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Evansville	Indiana
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Lake Oswego	Oregon
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Owensboro	Kentucky
United States	Novartis Investigative Site	Providence	Rhode Island
United States	Novartis Investigative Site	Rochester	Minnesota
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	South Burlington	Vermont
United States	Novartis Investigative Site	Toledo	Ohio
United States	Novartis Investigative Site	Waldorf	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Greece,  Japan,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One Treatment Emergent Adverse Event (AE)	The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest.	Within 16 weeks after Week 48
Secondary	Percentage of Subjects Having Achieved UAS7 = 6	The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations: Sustained remission defined as maintaining (Urticaria Activity Score) UAS7 = 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.	Baseline, Week 52 and Week 100
Secondary	Number and Proportion of Participants Who Achieved UAS7= 6	Summary of subjects with UAS7 = 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7= 6) at end of the treatment period (Week 52) and end of follow up period (Week 100).	Baseline, Week 52, Week 100

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com
•   Core study