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

October 7, 2021 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Novartis Investigative Site
      • Sydney, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1V 4W2
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M4V 1R2
        • Novartis Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
    • Bayern
      • Muenchen, Bayern, Germany, 80377
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Novartis Investigative Site
      • Athens, Greece, 12462
        • Novartis Investigative Site
    • GR
      • Athens, GR, Greece, 115 27
        • Novartis Investigative Site
  • Japan
      • Hiroshima, Japan, 734-8551
        • Novartis Investigative Site
    • Hokkaido
      • Obihiro, Hokkaido, Japan, 080 0013
        • Novartis Investigative Site
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 221-0825
        • Novartis Investigative Site
    • Kumamoto
      • Kamimashi-gun, Kumamoto, Japan, 861-3101
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 602-8566
        • Novartis Investigative Site
    • Osaka
      • Sakai, Osaka, Japan, 593-8324
        • Novartis Investigative Site
    • Saitama
      • Saitama-city, Saitama, Japan, 330-0854
        • Novartis Investigative Site
    • Tokyo
      • Machida-city, Tokyo, Japan, 194-0013
        • Novartis Investigative Site
      • Ota-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
      • Shinagawa ku, Tokyo, Japan, 141 8625
        • Novartis Investigative Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454092
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115478
        • Novartis Investigative Site
      • Smolensk, Russian Federation, 214019
        • Novartis Investigative Site
      • St Petersburg, Russian Federation, 194223
        • Novartis Investigative Site
      • St.-Petersburg, Russian Federation, 195112
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29009
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08003
        • Novartis Investigative Site
      • Barcelona, Cataluna, Spain, 08035
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46015
        • Novartis Investigative Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 407
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Tao Yuan, Taiwan, 333
        • Novartis Investigative Site
  • United Kingdom
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Novartis Investigative Site
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novartis Investigative Site
    • Florida
      • Sarasota, Florida, United States, 34233
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Novartis Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
    • Maryland
      • Waldorf, Maryland, United States, 20602
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novartis Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Novartis Investigative Site
      • Toledo, Ohio, United States, 43617
        • Novartis Investigative Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Novartis Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76132
        • Novartis Investigative Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ligelizumab
QGE031 240 mg s.c. q4w x 13 treatments
Biological: Ligelizumab
QGE031 240 mg s.c. q4w
Other Names:
  • QGE031

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
Time Frame: Within 16 weeks after Week 48
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Having Achieved UAS7 ≤ 6
Time Frame: Baseline, Week 52 and Week 100

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
Number and Proportion of Participants Who Achieved UAS7≤ 6
Time Frame: Baseline, Week 52, Week 100
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2016

Primary Completion (Actual)

May 2, 2019

Study Completion (Actual)

May 2, 2019

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGE031C2201E1
  • 2015-003636-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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