A study to see how safe and how effective remibrutinib is for people suffering from urticaria
- Conditions
- Health Condition 1: L508- Other urticaria
- Registration Number
- CTRI/2024/01/061601
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
CSU duration for = 6 months prior to screening.
Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as:
The presence of itch and hives for =6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period.
UAS7 score (range 0-42) =16, ISS7 score (range 0-21) = 6 and HSS7 score (range 0- 21) = 6 during the 7 days prior to randomization (Day 1).
Documentation of hives within three months before randomization.
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).
Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7 at Week 12Timepoint: To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participants with respect to change from baseline in UAS7 at Week 12 <br/ ><br>Physical Examination is carried out in every visis for Source documentation purpose. <br/ ><br>Vital signs, IRT transaction is carried out in every visit. <br/ ><br>ECG is done on Screening, Randomization and every 12 week till EOT.
- Secondary Outcome Measures
Name Time Method To demonstrate that remibrutinib (25 mg b.i.d.) is superior to placebo in CSU participantsTimepoint: Week 12;To demonstrate the safety and tolerability of remibrutinib (25 mg b.i.d.)Timepoint: 68 weeks