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Monoclonal Antibodies

Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFS for Chronic Urticaria

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 of the extension study
Awards & highlights

Study Summary

This trial is to establish the efficacy and safety of ligelizumab for people with chronic spontaneous urticaria who have relapsed despite standard treatment. A subset of subjects will just receive ligelizumab to assess safety and efficacy.

Eligible Conditions
  • Chronic Urticaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 of the extension study
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 of the extension study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
Secondary outcome measures
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
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
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
+4 more

Side effects data

From 2022 Phase 3 trial • 1078 Patients • NCT03580356
8%
Nasopharyngitis
7%
Headache
4%
COVID-19
3%
Arthralgia
3%
Migraine
3%
Diarrhoea
3%
Injection site swelling
3%
Influenza
2%
Myalgia
2%
Injection site urticaria
2%
Chronic spontaneous urticaria
2%
Anaemia
2%
Toothache
2%
Gastritis
2%
Injection site erythema
2%
Pyrexia
2%
Back pain
2%
Dysmenorrhoea
2%
Oropharyngeal pain
1%
Dermatitis contact
1%
Angioedema
1%
Hypertension
1%
Pharyngitis
1%
Oral herpes
1%
Fatigue
1%
Abdominal pain
1%
Bronchitis
1%
Injection site reaction
1%
Urticaria
1%
Upper respiratory tract infection
1%
Urinary tract infection
1%
SARS-CoV-2 test negative
1%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transitioned to Ligelizumab 120mg (Adults)
Placebo Only (Adults)
Ligelizumab 72mg (Adults)
Ligelizumab 120 mg (Adolescents)
Ligelizumab 72mg (Adolescents)
Ligelizumab 72mg (Adults+Adolescents)
Ligelizumab 120 mg (Adults)
Omalizumab 300mg (Adults)
Omalizumab 300mg (Adolescents)
Placebo Only (Adolescents)
Placebo Only (Adults+Adolescents)
Transitioned to Ligelizumab 120mg (Adults+Adolescents)
Ligelizumab 120 mg (Adults+Adolescents)
Omalizumab 300mg (Adults+Adolescents)
Transitioned to Ligelizumab 120mg (Adolescents)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ligelizumab 72 mg LIVI -ligelizumab 120 mg PFSExperimental Treatment1 Intervention
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).
Group II: Ligelizumab 120 mg LIVI -ligelizumab 120 mg PFSExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Ligelizumab
2019
Completed Phase 3
~2500

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,857 Previous Clinical Trials
4,196,768 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,091 Patients Enrolled for Chronic Urticaria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
2020. "Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210843.
~207 spots leftby Apr 2025
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