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Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

NCT05024058•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Detailed Description

There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.
•* Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
•* Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
•* Positive response (i.e. development of symptoms) to provocation test on day of randomization
•* Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
•* Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
•* Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules

Exclusion Criteria

•History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests
•* Participants who have concomitant CSU at screening
•* Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
•* Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
•* Diseases, other than chronic inducible 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).
•* Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
•* Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies

Locations (24)

Novartis Investigative Site

Evansville, Indiana, United States

Novartis Investigative Site

North Charleston, South Carolina, United States

Novartis Investigative Site

El Paso, Texas, United States

Novartis Investigative Site

Murray, Utah, United States

Novartis Investigative Site

East Melbourne, Victoria, Australia

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Debrecen, Hajdú-Bihar, Hungary

Novartis Investigative Site

Pécs, Hungary

Novartis Investigative Site

Szeged, Hungary

Key Dates

Start Date

November 16, 2021

Primary Completion Date

August 9, 2022

Completion Date

August 9, 2022

Last Updated

June 18, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Inducible Urticaria

Interventions

Ligelizumab

DRUG

Placebo

OTHER

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

NCT07266402

Chronic Inducible UrticariaCold Urticaria+2 more

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RECRUITINGPHASE2

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

NCT06931405

Chronic Inducible UrticariaChronic Spontaneous Urticaria

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria

Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria