Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
(PEARL-PROVOKE Trial)
Recruiting in Palo Alto (17 mi)
+58 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novartis Pharmaceuticals
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines
Eligibility Criteria
Inclusion Criteria
The subject had a positive response (i.e
The test must be physically possible for the participant, and must be specific to their CINDU.
Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization
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Treatment Details
Interventions
- Ligelizumab (Monoclonal Antibodies)
- Placebo ()
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novartis Investigative SiteWhite Marsh, MD
Novartis Investigative SiteOcean City, NJ
Novartis Investigative SiteLouisville, KY
Novartis Investigative SiteToledo, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor