An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

JRCT ID: jRCT2031220499

Registered date:08/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: chronic spontaneous urticaria
• Date of first enrollment: 10/12/2022
• Target sample size: 57
• Countries of recruitment: Australia,Japan,India,Japan,Korea,Japan,Taiwan,Japan,Turkey,Japan,Argentina,Japan,Colombia,Japan,Mexico,Japan,Bulgaria,Japan,Czech Republic,Japan,France,Japan,Hungary,Japan,Italy,Japan,United States,Japan,Russia,Japan,Malaysia,Japan,Thailand,Japan,Vietnam,Japan,China,Japan,Brazil,Japan,Canada,Japan,Denmark,Japan,Germany,Japan,Poland,Japan,Slovakia,Japan,Switzerland,Japan,United Kingdom,Japan,South Africa,Japan,Singapore,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Drug A : LOU064 Oral (blinded) or LOU064 (open label)
LOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles.

Drug B : Placebo Oral or LOU064 (open label)
LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles

Drug C: LOU064 Oral (open-label)
LOU064 (open-label) taken orally for 24 weeks per treatment cycle

Outcome(s)

Primary Outcome

Time to first composite event (i.e., relapse (UAS7>=16) [ Time Frame: 24 weeks ]
The efficacy of remibrutinib in CSU participants with a UAS7<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo. (Epoch 1)

Time to first composite event (i.e., relapse (UAS7>=16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period (Epoch 1)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Written informed consent must be obtained before any assessment is performed.
- Male and female, adult participants >=18 years of age.
- Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
- Willing and able to adhere to the study protocol and visit schedule.

Exclude criteria

- Significant bleeding risk or coagulation disorders.
- History of gastrointestinal bleeding.
- Requirement for anti-platelet medication.
- Requirement for anticoagulant medication.
- History or current hepatic disease.
- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.

Related Information

• Primary Sponsor: Maruyama Hideki
• Secondary ID(s): NCT05513001