An extension study of long-term efficacy and safety of remibrutinib in the treatment of chronic spontaneous urticaria participants who completed studies with remibrutinib

A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies. - LOU064 Roll over

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061150

Enrollment

582

Registered

2024-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L508- Other urticaria

Interventions

Intervention1: Remibrutinib: 25 mg bid given orally for 24 week Intervention2: Placebo: given orally for 24 week Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of remibrutinib in CSU participants with a UAS7 (Weekly Urticaria Activity Score)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.Timepoint: relapse, defined as UAS7â?¥16 up to Week 24	—

Measure

Time frame

To assess the efficacy of remibrutinib in CSU participants with a UAS7 (Weekly Urticaria Activity Score)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.Timepoint: relapse, defined as UAS7â?¥16 up to Week 24

—

Secondary

Measure	Time frame
To assess the long-term safety & tolerability of remibrutinibTimepoint: every 12 week	—

Countries

Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Portugal, Republic of Korea, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMurugananthan K

Novartis Healthcare Pvt Ltd

murugananthan.k@novartis.com912250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026