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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04210843
Ethics application status
Date submitted
17/12/2019
Date registered
26/12/2019
Date last updated
30/03/2021

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ligelizumab

Experimental: Ligelizumab Dose 1 and 3 - Liquid in vial 72 mg/mL followed by 120 mg/mL PFS

Experimental: Ligelizumab Dose 2 and 3 - Liquid in vial 120 mg/mL followed by 120 mg/mL PFS


Treatment: Drugs: Ligelizumab
liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of subjects with well-controlled disease (UAS7 = 6) at Week 12 - The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).
The HSS, defined by number of hives (wheals), will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0 - 21.
The severity of the itch will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0-21 (maximum itch).
The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Complete control of chronic spontaneous urticaria (CSU) at Week 12 - Assessed as the proportion of subjects with completely controlled disease (UAS7 =0) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
A reduction from extension study baseline in the UAS7 at Week 12 - Assessed as absolute change from extension study baseline in the UAS7 at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
A reduction from extension study baseline in the ISS7 at Week 12 - Assessed as absolute change from extension study baseline in the ISS7 (weekly itch severity score) at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
A reduction from extension study baseline in the HSS7 at Week 12 - Assessed as absolute change from extension study baseline in the HSS7 (weekly hives severity score) at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Achieving an angioedema-free period at Week 12 - Assessed as cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Achieving Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 - Assessed as percentage of subjects achieving DLQI = 0-1 at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Efficacy of ligelizumab in the treatment of CSU, 12 weeks after starting self-administration - Assessed as the proportion of subjects with well-controlled disease (UAS7 = 6), 12 weeks after starting self-administration
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer - Occurence of Adverse Events for patients who self-administer
Timepoint [8] 0 0
from Week 24 to Week 104

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, CQGE031C2303, CQGE031C2202 or
CQGE031C1301

- 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
Gender
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, CQGE031C2303 or CQGE031C2202.

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

This study will also fulfill the Novartis commitment to provide post-trial access to patients
who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301
Trial website
https://clinicaltrials.gov/show/NCT04210843
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
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04210843