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

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ClinicalTrials.gov Identifier: NCT02649218
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 patients who completed study CQGE031C2201

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Biological: QGE031 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 24, 2016
Estimated Primary Completion Date : May 6, 2019
Estimated Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: Arm 1
QGE031 every 4 weeks x 13 treatments
Biological: QGE031
QGE031




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (AEs) [ Time Frame: 2 years ]
    The primary objective of this study is to assess the long-term safety of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with AEs of non-serious and serious adverse events including any events of special interest.


Secondary Outcome Measures :
  1. Number of participants with sustained remission [ Time Frame: 2 years ]

    The secondary objective of this study is 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 UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch.




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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649218


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Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02649218     History of Changes
Other Study ID Numbers: CQGE031C2201E1
2015-003636-13 ( EudraCT Number )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QGE031
chronic
spontaneous
Urticaria
CSU
adults
Safety

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases