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Monoclonal Antibodies

Ligelizumab for Chronic Urticaria (PEARL-PROVOKE Trial)

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 12
Awards & highlights
Pivotal Trial

Summary

This trial will test if the drug ligelizumab is effective and safe for people with chronic inducible urticaria who haven't been helped by H1-antihistamines.

Eligible Conditions
  • Chronic Urticaria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria
Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria
Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism
Secondary study objectives
Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria
Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism
Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0
+3 more

Side effects data

From 2022 Phase 3 trial • 1078 Patients • NCT03580356
7%
Nasopharyngitis
6%
Headache
4%
COVID-19
3%
Migraine
3%
Injection site swelling
3%
Influenza
3%
Diarrhoea
3%
Arthralgia
2%
Injection site erythema
2%
Injection site urticaria
2%
Back pain
2%
Pyrexia
2%
Pharyngitis
2%
Chronic spontaneous urticaria
2%
Anaemia
2%
Toothache
2%
Myalgia
2%
Urticaria
2%
Oropharyngeal pain
2%
Gastritis
2%
Dysmenorrhoea
1%
Urinary tract infection
1%
Hypertension
1%
Dermatitis contact
1%
Upper respiratory tract infection
1%
SARS-CoV-2 test negative
1%
Injection site reaction
1%
Oral herpes
1%
Bronchitis
1%
Acne
1%
Angioedema
1%
Abdominal pain
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transitioned to Ligelizumab 120mg (Adults+Adolescents)
Transitioned to Ligelizumab 120mg (Adults)
Placebo Only (Adults+Adolescents)
Transitioned to Ligelizumab 120mg (Adolescents)
Ligelizumab 120 mg (Adolescents)
Placebo Only (Adolescents)
Omalizumab 300mg (Adolescents)
Ligelizumab 72mg (Adults)
Ligelizumab 72mg (Adults+Adolescents)
Ligelizumab 72mg (Adolescents)
Omalizumab 300mg (Adults)
Ligelizumab 120 mg (Adults)
Placebo Only (Adults)
Ligelizumab 120 mg (Adults+Adolescents)
Omalizumab 300mg (Adults+Adolescents)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Ligelizumab low dose, symptomatic dermographism groupExperimental Treatment1 Intervention
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Group II: Ligelizumab low dose, cold urticariaExperimental Treatment1 Intervention
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria
Group III: Ligelizumab high dose, symptomatic dermographismExperimental Treatment1 Intervention
Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Group IV: Ligelizumab high dose, cold urticariaExperimental Treatment1 Intervention
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria
Group V: Ligelizumab high dose, cholinergic urticariaExperimental Treatment1 Intervention
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Group VI: Placebo SC q4w, cholinergic urticariaPlacebo Group1 Intervention
Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Group VII: Placebo SC q4w, cold urticariaPlacebo Group1 Intervention
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria
Group VIII: Placebo SC q4W, symptomatic dermographismPlacebo Group1 Intervention
Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism
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
2,911 Previous Clinical Trials
4,250,616 Total Patients Enrolled
28 Trials studying Chronic Urticaria
8,812 Patients Enrolled for Chronic Urticaria
~10 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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