A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequate… (NCT05048342) | Clinical Trial Compass
CompletedPhase 3
A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines
Japan71 participantsStarted 2022-01-15
Plain-language summary
The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine (H1-AH) at locally label approved doses, for a duration of 52 weeks of treatment with remibrutinib and a post-treatment follow-up period of up to 4 weeks.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria:
* Signed informed consent was required to be obtained prior to participation in the study.
* Male and female patients \>= 18 years of age at the time of screening
* CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
* Diagnosis of CSU inadequately controlled by second generation H1-AHs at the time of baseline (Day 1) defined as:
* The presence of itch and hives for \>= 6 consecutive weeks prior to screening despite the use of second generation H1-AHs 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 baseline (Day 1)
* Documentation of hives within three months before baseline (either at screening and/or at baseline; or documented in the patients' medical history)
* Willing and able to complete an UPDD for the duration of the study and adhere to the study protocol
* Patients were required to not have more than one missing UPDD entry (either morning or evening) in the 7 days prior to baseline (Day 1)
Exclusion criteria:
* Patients having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
* Other diseases with symptoms of urticaria or angioedem…
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events
Timeframe: Baseline up to 30 days after last dose of study medication, assessed up to approximately 56 weeks