NCT05513001

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

Detailed description

This is a Phase 3b multicenter, double-blind, placebo-controlled, randomized withdrawal, and open-label extension study to evaluate the efficacy and safety of remibrutinib 25 mg twice daily (b.i.d.) in adult CSU participants who have completed one of the preceding Phase 3 core studies. The study comprises 2 Epochs: Epoch 1 is the initial study period and includes participants from preceding Phase 3 studies. It consists of a 24-week randomized withdrawal period where participants receive either remibrutinib 25 mg b.i.d. or placebo if their UAS7 score is less than 16. For those with a UAS7 score of 16 or higher, there is a 24-week open-label treatment period with remibrutinib 25 mg b.i.d. Participants are randomized 1:1 to the double-blind placebo-controlled withdrawal phase. All participants will continue their background H1-AH treatment. If participants relapse (UAS7 ≥ 16) in the blinded group, they enter the (Re-)treatment period of Epoch 1 and receive 24 weeks of open-label treatment with remibrutinib 25 mg b.i.d. After this period, they move to Epoch 2. Epoch 2 is the second subsequent study period and consists of 24-week cycles that may include treatment-free observation and/or open-label (Re-)treatment periods with remibrutinib 25 mg b.i.d., with or without background H1-AH, at the investigator's discretion. Participants from future Phase 3 remibrutinib studies may also join Epoch 2 if approved. If participants relapse (UAS7 ≥ 16) during an observation period, they enter the next (Re-)treatment period for 24 weeks of treatment with remibrutinib 25 mg b.i.d. Participants completing an observation period with a UAS7 ≤ 6 will complete the study with an end-of-study (EOS) visit. Those with a UAS7 \> 6 but \< 16 can enter the next (Re-)treatment period if continuous treatment is deemed necessary. Participants with a UAS7 \< 16 in the previous treatment period will receive remibrutinib monotherapy (without background H1-AH). If treatment continuation is not necessary, they complete the EOS visit and leave the study. Participants with a UAS7 ≥ 16 during the observation period will enter the corresponding (Re-)treatment period to continue treatment. Throughout Epoch 2, the use of background H1-AH is at the investigator's discretion, except for participants with a UAS7 \< 16 in the previous treatment period, who will be treated with remibrutinib monotherapy.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	LOU064 (blinded)	LOU064 (blinded) active treatment
DRUG	Placebo	Placebo
DRUG	LOU064 (open label)	LOU064 (open-label) active treatment

Timeline

• Start date: 2022-12-09
• Primary completion: 2024-08-26
• Completion: 2027-08-02
• First posted: 2022-08-23
• Last updated: 2026-03-11

Locations

208 sites across 30 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Malaysia, Poland, Puerto Rico, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study