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

Testing Remibrutinib's effectiveness and safety for CINDU not controlled by antihistamines.

Recruiting
18 years and older
All
Phase 3

This study is looking at how well a drug called remibrutinib works for adults with a condition called CINDU, which is a skin problem causing itchy hives not controlled by H1-antihistamines (H1-AHs). The study lasts about 60 weeks and is divided into two main parts: the Core period and the Open-label Extension (OLE).

In the Core period, there are several stages:

  • Screening (up to 4 weeks): Doctors check if you can join.
  • Double-blind treatment (24 weeks): You’ll get either remibrutinib or a placebo, but won't know which.
  • Open-label treatment (28 weeks): All get remibrutinib.
  • Follow-up (4 weeks): No treatment, but doctors check on you.

If you still have symptoms after the Core period, you may join the OLE, which could last up to 3 years. Here, you may receive remibrutinib if you need it. To join, you must be 18 or older, have CINDU for at least 4 months, and not have taken remibrutinib before.

  • Length: Up to 60 weeks for Core, plus 3 years for OLE.
  • Visits: Regular visits required for check-ups.
  • Risk: Unknown effects of remibrutinib.
Study details
    Chronic Inducible Urticaria

NCT05976243

Novartis Pharmaceuticals

8 March 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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