TerminatedPhase 3

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

Stopped: Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.

United States, Australia, Greece39 participantsStarted 2021-11-16

Plain-language 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

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism

Timeframe: Baseline, Week 12

Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria

Timeframe: Baseline, Week 12

Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT05024058

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-09

Results submitted2023-02-09

View on ClinicalTrials.gov More Chronic Inducible Urticaria trials

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

United States, Australia, Greece39 participantsStarted 2021-11-16

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism

Timeframe: Baseline, Week 12

Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria

Timeframe: Baseline, Week 12

Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria

Timeframe: Baseline, Week 12