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

ClinicalTrials.gov Identifier: NCT05024058

Novartis Reference Number: CQGE031E12301

Last Update: May 11, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

This is 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

Condition

Chronic Inducible Urticaria

Phase

Phase 3

Overall status

Recruiting

Start date

Nov 16, 2021

Completion date

Dec 27, 2024

Gender

All

Age(s)

12 Years and older (Child, Adult, Older Adult)

Interventions

Drug

Ligelizumab

Ligelizumab treated groups and arms

Other

Placebo

Placebo treated groups and arms

Eligibility Criteria

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