A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

Launched by NOVARTIS PHARMACEUTICALS · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called remibrutinib to see if it helps adults with a condition known as Chronic Inducible Urticaria (CINDU), which causes sudden skin reactions like hives or itching that are not well controlled by standard allergy medications. The trial will last for 52 weeks, during which some participants will receive remibrutinib while others will receive a placebo (a treatment that looks like the real medication but has no active ingredients) without knowing which one they are getting. This helps researchers determine how effective and safe remibrutinib is compared to no treatment.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with CINDU for at least four months. They should also be experiencing symptoms that are not adequately managed by current allergy medications. Participants who complete the initial 52 weeks may have the option to continue in a follow-up phase to gather more long-term data. It's important for potential participants to discuss their medical history with their doctor to see if they qualify. Throughout the trial, participants will be monitored for the effectiveness of the treatment and any side effects.

Gender

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Eligibility 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