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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

PEARL-PROVOKE 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

PEARL-PROVOKE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
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)

PEARL-PROVOKE 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, cold urticariaPlacebo Group1 Intervention
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria
Group VII: Placebo SC q4w, cholinergic urticariaPlacebo Group1 Intervention
Placebo subcutaneous injections every 4 weeks in participants with cholinergic 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
2,856 Previous Clinical Trials
4,197,666 Total Patients Enrolled
28 Trials studying Chronic Urticaria
9,124 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.

Are new patients currently being enrolled in this clinical trial?

"Based on the information available through clinicaltrials.gov, this study is still looking for participants and actively recruiting. The trial was first posted on November 16th, 2021 and has had some updates made as recently as September 23rd, 2022."

Answered by AI

What other scientific research has been conducted using Ligelizumab?

"There are a total of two live clinical trials for Ligelizumab, both of which have progressed to Phase 3. In addition to the numerous studies being conducted in Odense, Pennsylvania; there are 121 other medical facilities running similar experiments."

Answered by AI

Are there any participating North American hospitals in this clinical trial?

"There are 12 sites for this clinical trial, with enrolment happening in locations such as Huntington Beach, White Marsh and Orlando. To reduce the demand of travel on participants, it is encouraged that you select the location nearest to you."

Answered by AI

What are the possible negative effects of Ligelizumab?

"Ligelizumab has received a score of 3 for safety. This is because there is already some data supporting its efficacy and multiple rounds of testing have provided evidence that it is safe."

Answered by AI

As far as you know, is this the initial research project of its type?

"2 trials studying Ligelizumab are ongoing in 70 cities and 20 countries. The first trial began in 2021. Novartis Pharmaceuticals sponsored the Phase 3 drug approval stage of the study, which 428 patients completed. Since then, 18293 other studies have been conducted."

Answered by AI

How many individuals are being observed in this clinical trial?

"That is correct. The website clinicaltrials.gov has the most recent information on this study, which was posted on November 16th, 2021 and edited September 23rd, 2022. There are 12 different centres enrolling 428 patients in total."

Answered by AI

Why was this clinical trial designed and what are its key goals?

"The main metric of success for this study, which will be evaluated around Week 12, is the Change from baseline in Total Fric Score for patients with symptomatic dermographism. Additionally, researchers will evaluate the Proportion of participants with cold urticaria who have a complete response to the TempTest, the Proportion of participants with cholinergic urticaria who have PGA - hive score =0 , and the Proportion of participants with cholinergic urticaria who have itch numerical rating scale =0 ."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
2021. "Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05024058.
~11 spots leftby Apr 2025
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