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

March 10, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

696

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahía Blanca, Argentina, B8000JRB
        • Novartis Investigative Site
      • CABA, Argentina, C1181ACH
        • Novartis Investigative Site
      • Capital Federal, Argentina, C1023AAB
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1837AVT
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1414AIF
        • Novartis Investigative Site
      • La Plata, Buenos Aires, Argentina, B1902COS
        • Novartis Investigative Site
    • Nueve De Julio
      • Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Novartis Investigative Site
      • Rosario, Santa Fe Province, Argentina, S2000JKR
        • Novartis Investigative Site
  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Novartis Investigative Site
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
  • Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-870
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1407
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2M 1A6
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T6G 1C3
        • Novartis Investigative Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Novartis Investigative Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Novartis Investigative Site
      • London, Ontario, Canada, N6H 5L5
        • Novartis Investigative Site
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1G 6C6
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M3B 3S6
        • Novartis Investigative Site
    • Quebec
      • Verdun, Quebec, Canada, H4G 3E7
        • Novartis Investigative Site
  • China
      • Beijing, China, 100050
        • Novartis Investigative Site
      • Beijing, China, 100191
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Novartis Investigative Site
      • Shanghai, China, 200443
        • Novartis Investigative Site
      • Tianjin, China, 300052
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510630
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510091
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Novartis Investigative Site
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310003
        • Novartis Investigative Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050010
        • Novartis Investigative Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Novartis Investigative Site
      • Barranquilla, Atlántico, Colombia, 080020
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110221
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 602 00
        • Novartis Investigative Site
      • Olomouc, Czechia, 779 00
        • Novartis Investigative Site
      • Plzen Bory, Czechia, 301 00
        • Novartis Investigative Site
      • Prague, Czechia, 150 06
        • Novartis Investigative Site
  • Denmark
      • Hellerup, Denmark, 2900
        • Novartis Investigative Site
      • Kobenhavn N V, Denmark, 2400
        • Novartis Investigative Site
  • France
      • Angers, France, 49933
        • Novartis Investigative Site
      • Antony, France, 92160
        • Novartis Investigative Site
      • Bordeaux, France, 33075
        • Novartis Investigative Site
      • Brest, France, 29609
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Novartis Investigative Site
      • Nice, France, 06000
        • Novartis Investigative Site
      • Paris, France, 75970
        • Novartis Investigative Site
      • Pierre-Bénite, France, 69495
        • Novartis Investigative Site
      • Reims, France, 51100
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Novartis Investigative Site
      • Saint-Mandé, France, 94160
        • Novartis Investigative Site
      • Toulouse, France, 31400
        • Novartis Investigative Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Berlin, Germany, 13187
        • Novartis Investigative Site
      • Hanover, Germany, 30625
        • Novartis Investigative Site
      • Lübeck, Germany, 23538
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • München, Germany, 80377
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Novartis Investigative Site
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • Novartis Investigative Site
    • Lower Saxony
      • Bramsche, Lower Saxony, Germany, 49565
        • Novartis Investigative Site
      • Göttingen, Lower Saxony, Germany, 37075
        • Novartis Investigative Site
    • Saarland
      • Merzig, Saarland, Germany, 66663
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Novartis Investigative Site
      • Leipzig, Saxony, Germany, 04103
        • Novartis Investigative Site
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Novartis Investigative Site
      • Halle, Saxony-Anhalt, Germany, 06108
        • Novartis Investigative Site
  • Hungary
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Novartis Investigative Site
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4031
        • Novartis Investigative Site
  • India
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60126
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20162
        • Novartis Investigative Site
  • Japan
      • Hiroshima, Japan, 7348551
        • Novartis Investigative Site
      • Osaka, Japan, 558-0003
        • Novartis Investigative Site
      • Osaka, Japan, 554 0014
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4548509
        • Novartis Investigative Site
    • Chiba
      • Urayasu, Chiba, Japan, 279-0011
        • Novartis Investigative Site
    • Hokkaido
      • Obihiro, Hokkaido, Japan, 080 0013
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 220-6208
        • Novartis Investigative Site
    • Kumamoto
      • Kamimashi-gun, Kumamoto, Japan, 861-3106
        • Novartis Investigative Site
    • Osaka
      • Izumiōtsu, Osaka, Japan, 5950025
        • Novartis Investigative Site
      • Neyagawa, Osaka, Japan, 5720838
        • Novartis Investigative Site
      • Sakai, Osaka, Japan, 5938324
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 5698686
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 5690824
        • Novartis Investigative Site
    • Shimane
      • Izumo, Shimane, Japan, 693 8501
        • Novartis Investigative Site
    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 1738610
        • Novartis Investigative Site
      • Koto, Tokyo, Japan, 136-0074
        • Novartis Investigative Site
      • Minato, Tokyo, Japan, 108-0014
        • Novartis Investigative Site
      • Ōta-ku, Tokyo, Japan, 143-0023
        • Novartis Investigative Site
  • Malaysia
      • Wilayah Persekutuan, Malaysia, 62502
        • Novartis Investigative Site
    • Johor
      • Muar town, Johor, Malaysia, 84000
        • Novartis Investigative Site
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Novartis Investigative Site
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Novartis Investigative Site
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15 276
        • Novartis Investigative Site
      • Lodz, Poland, 90-265
        • Novartis Investigative Site
      • Poznan, Poland, 60-693
        • Novartis Investigative Site
      • Poznan, Poland, 60-823
        • Novartis Investigative Site
      • Warsaw, Poland, 02-507
        • Novartis Investigative Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Alma Cruz-Santana Private Practice
  • Russia
      • Izhevsk, Russia, 426061
        • Novartis Investigative Site
      • Ryazan, Russia, 390039
        • Novartis Investigative Site
      • Ryazan, Russia, 390046
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 199226
        • Novartis Investigative Site
      • Stavropol, Russia, 355000
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 308205
        • Novartis Investigative Site
  • Slovakia
      • Kežmarok, Slovakia, 060 01
        • Novartis Investigative Site
      • Komárno, Slovakia, 945 01
        • Novartis Investigative Site
      • Košice, Slovakia, 041 90
        • Novartis Investigative Site
      • Levice, Slovakia, 934 01
        • Novartis Investigative Site
      • Nové Zámky, Slovakia, 940 34
        • Novartis Investigative Site
      • Svidník, Slovakia, 089 01
        • Novartis Investigative Site
  • South Africa
      • Pretoria, South Africa, 0181
        • Novartis Investigative Site
    • Western Province
      • Cape Town, Western Province, South Africa, 7700
        • Novartis Investigative Site
  • South Korea
      • Gwangju, South Korea, 61469
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
      • Seoul, South Korea, 07441
        • Novartis Investigative Site
    • Dalseo Gu
      • Daegu, Dalseo Gu, South Korea, 42602
        • Novartis Investigative Site
    • Gyeonggi-do
      • Hwaseong-si, Gyeonggi-do, South Korea, 18450
        • Novartis Investigative Site
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Novartis Investigative Site
    • Korea
      • Incheon, Korea, South Korea, 405 760
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 03080
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 07061
        • Novartis Investigative Site
  • Spain
      • Alicante, Spain, 03010
        • Novartis Investigative Site
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
      • Las Palmas GC, Spain, 35010
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Novartis Investigative Site
      • Madrid, Spain, 280796
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Novartis Investigative Site
      • Valencia, Spain, 46015
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Zurich, Switzerland, 8091
        • Novartis Investigative Site
      • Zurich, Switzerland, 8006
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 407219
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taoyuan District, Taiwan, 33305
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, Thailand, 40002
        • Novartis Investigative Site
  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35100
        • Novartis Investigative Site
      • Kayseri, Turkey (Türkiye), 38070
        • Novartis Investigative Site
    • Adapazari
      • Sakarya, Adapazari, Turkey (Türkiye), 54290
        • Novartis Investigative Site
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55200
        • Novartis Investigative Site
    • Buca
      • Izmir, Buca, Turkey (Türkiye), 35390
        • Novartis Investigative Site
    • Efeler
      • Aydin, Efeler, Turkey (Türkiye), 09100
        • Novartis Investigative Site
    • Karabaglar
      • Izmir, Karabaglar, Turkey (Türkiye), 35170
        • Novartis Investigative Site
    • Karsiyaka
      • Izmir, Karsiyaka, Turkey (Türkiye), 35620
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Novartis Investigative Site
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye), 34662
        • Novartis Investigative Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Allervie Clinical Research
      • Birmingham, Alabama, United States, 35244
        • Cahaba Derm and skin hlth ctr 27
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Acuro Research Inc
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Research Trials
    • California
      • Bakersfield, California, United States, 93301
        • Kern Research
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
      • Redwood City, California, United States, 94063
        • Allergy and Asthma Consultants
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Asthma and Allergy Associates P C
      • Denver, Colorado, United States, 80230
        • Colorado Allergy and Asthma Ctr PC
    • Connecticut
      • Farmington, Connecticut, United States, 06030-2840
        • UCONN Health Dermatology
    • Florida
      • Aventura, Florida, United States, 33180
        • Florida Ctr Allergy Asthma Research
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research
      • Sarasota, Florida, United States, 34233
        • Sarasota Clinical Research
      • Tallahassee, Florida, United States, 32308
        • Allergy and Asthma Diagnostic Treatment Center
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Aeroallergy Research Laboratories
    • Idaho
      • Boise, Idaho, United States, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Glenview, Illinois, United States, 60077
        • Endeavor Health
      • River Forest, Illinois, United States, 60305
        • Asthma and Allergy Center of Chicago S C
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Deaconess Clin Allerg Res Inst
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Allergy and Asthma Specialist P S C
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • John Hopkins University
      • Chevy Chase, Maryland, United States, 20815
        • Institute for Asthma and Allergy PC
    • Missouri
      • St Louis, Missouri, United States, 63141
        • The Clinical Research Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Somnos Clinical Research
    • New Jersey
      • Little Silver, New Jersey, United States, 07739
        • Allergy Asthma Assoc Monmouth
    • Ohio
      • Athens, Ohio, United States, 45701
        • Oakview Dermatology
      • Columbus, Ohio, United States, 43235
        • Optimed Research LLC
      • Columbus, Ohio, United States, 43213
        • CR Services Acquisition US
      • Toledo, Ohio, United States, 43617
        • Toledo Institute of Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy Asthma and Clinical Research
      • Tulsa, Oklahoma, United States, 74136
        • Vital Prospects Clinical Research Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy and Clinical Immunology Associates
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • National Allergy and Asthma Research LLS
    • Texas
      • Austin, Texas, United States, 78759
        • Orion Clinical Research
      • El Paso, Texas, United States, 79924
        • Western Sky Medical Research
      • San Antonio, Texas, United States, 78213
        • RFSA Dermatology
    • Utah
      • Sandy City, Utah, United States, 84093
        • Allergy Associates of Utah
    • Washington
      • Bellingham, Washington, United States, 98225
        • Bellingham Asthma Allergy and Immunology
      • Seattle, Washington, United States, 98115
        • Seattle Allergy and Asthma Rsch
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Allergy Asthma and amp Sinus Ctr S C

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: LOU064 (blinded)
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. Randomized in a 1:1 ratio (arm 1:arm 2)
Drug: LOU064 (blinded)
LOU064 (blinded) active treatment
Other Names:
  • remibrutinib
Drug: LOU064 (open label)
LOU064 (open-label) active treatment
Other Names:
  • remibrutinib
Placebo Comparator: Arm 2: LOU064 Placebo (blinded)
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. Randomized in a 1:1 ratio (arm 1:arm 2)
Drug: Placebo
Placebo
Drug: LOU064 (open label)
LOU064 (open-label) active treatment
Other Names:
  • remibrutinib
Experimental: Arm 3: LOU064 (Open Label)
LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)
Drug: LOU064 (open label)
LOU064 (open-label) active treatment
Other Names:
  • remibrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

Urticaria Activity Score (UAS7) describes the number of hives with 0 being No Hives and 3 is most severe. The final score is calculated by adding together daily scores which can range from 0-6 for 7 days. The resulting maximum score is then 42.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent (serious and non-serious) adverse events
Time Frame: 160 weeks
Occurrence of treatment-emergent (serious and non-serious) adverse events
160 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2022

Primary Completion (Actual)

August 26, 2024

Study Completion (Estimated)

August 2, 2027

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOU064A2303B
  • 2022-001034-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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