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Evaluating Remibrutinib for Chronic Inducible Urticaria

A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled, Basket Study With an Open-label Extension to Investigate the Efficacy, Safety, and Tolerability of Remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in Adults Inadequately Controlled by H1-antihistamines

Phase 3 Interventional Novartis · NCT05976243

This study is testing if a new medication called remibrutinib can help adults with Chronic Inducible Urticaria who haven't found relief from standard allergy medications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment348 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsremibrutinib
Locations162 sites (Birmingham, Alabama and 161 other locations)
Trial IDNCT05976243 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial investigates the efficacy, safety, and tolerability of remibrutinib compared to a placebo in adults with Chronic Inducible Urticaria (CINDU) who have not achieved adequate control with H1-antihistamines. The study consists of a core period lasting up to 60 weeks, which includes a 24-week double-blind treatment phase followed by a 28-week open-label treatment phase. An optional Open-label Extension period allows participants to receive continued treatment based on their symptom status. The primary endpoint is assessed at Week 12, focusing on various CINDU subtypes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of CINDU inadequately controlled by H1-antihistamines.

Not a fit: Patients who have not been diagnosed with CINDU or those who have controlled symptoms with H1-antihistamines may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptom control for patients suffering from CINDU.

How similar studies have performed: Previous studies have shown promise in treating similar conditions with targeted therapies, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria for core period:

1. Male and female participants ≥18 years of age at the time of signing of the ICFs
2. Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization
3. The following response to the provocation test for each subtype is required at the randomization visit :

   * Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
   * Cold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
   * Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.
4. Cold Urticaria: Positive ice-cube test resulting in hives at the provocation site for participants at Screening.
5. Cholinergic urticaria: Participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.

Inclusion criteria for the OLE:

1. Participants who have completed the Core period up to Week 52 and are willing to enter the OLE period

   Exclusion Criteria for core period:
   * 1. Previous use of remibrutinib or other BTK inhibitors.
2. Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study.
3. Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.
4. 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.
5. Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema
6. Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism

There are no exclusion criteria for OLE

Where this trial is running

Birmingham, Alabama and 161 other locations

+112 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Inducible UrticariaCINDUChronic inducible urticariaBTKremibrutinibsymptomatic dermographsimcold urticariacholinergic urticaria
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.