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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04210843




Registration number
NCT04210843
Ethics application status
Date submitted
17/12/2019
Date registered
26/12/2019
Date last updated
20/06/2024

Titles & IDs
Public title
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Scientific title
A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Secondary ID [1] 0 0
2019-001792-37
Secondary ID [2] 0 0
CQGE031C2302E1
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: Drugs - Ligelizumab

Experimental: Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS - Participants received 72 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).

Experimental: Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFS - Participants received 120 mg of ligelizumab liquid in vial (LIVI) subcutaneously every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS) subcutaneously every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2).


Treatment: Drugs: Ligelizumab
For the first 12 weeks of treatment: i) participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg LIVI s.c. Q4W were treated with the same dose regimen in a double-blind manner; ii) all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg LIVI s.c. Q4W in a double-blind manner; iii) participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg LIVI s.c. Q4W in an open-label manner.

Thereafter, all participants were switched to ligelizumab 120 mg s.c. PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab.

The longest possible treatment was 104 weeks, however this treatment might not be continuous and might span over a period of 156 weeks due to the possibility of entering the intervening observation period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 = 6) at Week 12
Timepoint [1] 0 0
Week 12 of the extension study
Primary outcome [2] 0 0
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7= 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 = 6) at Week 12 of the Extension Study
Timepoint [2] 0 0
Week 12 of the extension study
Secondary outcome [1] 0 0
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12
Timepoint [1] 0 0
Week 12 of the extension study
Secondary outcome [2] 0 0
Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Timepoint [2] 0 0
Extension study baseline (Week 0), Week 12 of the extension study
Secondary outcome [3] 0 0
Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Timepoint [3] 0 0
Extension study baseline (Week 0), Week 12 of the extension study
Secondary outcome [4] 0 0
Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Timepoint [4] 0 0
Extension study baseline (Week 0), Week 12 of the extension study
Secondary outcome [5] 0 0
Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies
Timepoint [5] 0 0
From extension study baseline (Week 0) up to Week 12 of the extension study
Secondary outcome [6] 0 0
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12
Timepoint [6] 0 0
Week 12 of the extension study
Secondary outcome [7] 0 0
Percentage of Subjects With Well-controlled Disease (UAS7 = 6) 12 Weeks After Starting Self-administration
Timepoint [7] 0 0
Week 24 of the extension study

Eligibility
Key inclusion criteria
Key

* Written informed consent
* Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878)
* Male and female, adult and adolescent subjects =12 years of age
* Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment
* Use of omalizumab within 16 weeks of Screening
* History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes
* New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356) or CQGE031C2202 (NCT03437278).
* Diseases with possible symptoms of urticaria or angioedema
* Subjects with evidence of helminthic parasitic infection
* Documented history of anaphylaxis
* Pregnant or nursing (lactating) women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2022
Sample size
Target
Accrual to date
Final
1033
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3002 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Hanoi
Country [201] 0 0
Vietnam
State/province [201] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
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Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment.

This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
Trial website
https://clinicaltrials.gov/study/NCT04210843
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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/study/NCT04210843