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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03580356




Registration number
NCT03580356
Ethics application status
Date submitted
26/06/2018
Date registered
9/07/2018
Date last updated
25/03/2024

Titles & IDs
Public title
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Scientific title
A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Secondary ID [1] 0 0
2018-000840-24
Secondary ID [2] 0 0
CQGE031C2303
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
Other interventions - Ligelizumab
Other interventions - Omalizumab
Other interventions - Placebo

Experimental: Ligelizumab 120 mg - Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Experimental: Ligelizumab 72 mg - Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Active Comparator: Omalizumab 300 mg - Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Placebo Comparator: Placebo - Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48


Other interventions: Ligelizumab
Liquid in vial

Other interventions: Omalizumab
Lyophilized powder for solution in vial

Other interventions: Placebo
Liquid in vial
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
Timepoint [6] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
Key

- Signed informed consent must be obtained prior to participation in the study. The
subject's, parent's or legal guardian's signed written informed consent and child's
assent, if appropriate, must be obtained before any assessment is performed. Of note,
if the subject reaches age of consent (age as per local law) during the study, they
will also need to sign the corresponding study Informed Consent Form (ICF) at the next
study visit.

- Male and female subjects = 12 years of age at the time of screening.

- CSU diagnosis for = 6 months.

- Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization,
as defined by all of the following:

- The presence of itch and hives for = 6 consecutive weeks at any time prior to Visit 1
(Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine

- UAS7 score (range 0-42) = 16 and HSS7 (range 0-21) = 8 during the 7 days prior to
randomization (Visit 110, Day 1)

- Subjects must be on H1-antihistamine at only locally label approved doses for
treatment of CSU starting at Visit 1 (Day -28 to Day -14)

- Willing and able to complete a daily symptom eDiary for the duration of the study and
adhere to the study visit schedules.

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of hypersensitivity to any of the study drugs or their excipients or to drugs
of similar chemical classes (i.e. to murine, chimeric or human antibodies).

- Subjects having a clearly defined cause of their chronic urticaria, other than CSU.
This includes, but is not limited to, the following: symptomatic dermographism
(urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-,
cholinergic- or contact-urticaria.

- Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as
urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria
pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor
deficiency).

- Subjects with evidence of helminthic parasitic infection as evidenced by stools being
positive for a pathogenic organism according to local guidelines. All subjects will be
screened at Visit 1. If stool testing is positive for pathogenic organism, the subject
will not be randomized and will not be allowed to rescreen.

- Any other skin disease associated with chronic itching that might influence in the
investigators opinion the study evaluations and results (e.g. atopic dermatitis,
bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).

- Prior exposure to ligelizumab or omalizumab.

- H1-AH used as background medication at greater than locally label-approved doses after
visit 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2022
Sample size
Target
Accrual to date
Final
1078
Recruitment in Australia
Recruitment state(s)
SA,VIC
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Novartis Investigative Site - Adelaide
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Novartis Investigative Site - East Melbourne
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Novartis Investigative Site - Parkville
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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 study was to establish efficacy and safety of ligelizumab in adolescent
and adult subjects with CSU who remained symptomatic despite standard of care treatment by
demonstrating better efficacy over omalizumab and over placebo.

The study population consisted of 1,079 male and female subjects aged = 12 years who were
diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.

This was a multi-center, randomized, double-blind, active- and placebo-controlled,
parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind
treatment period, and a 12 week post-treatment follow-up period.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03580356
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/ct2/show/NCT03580356