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Active, not recruitingPhase 3

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

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Athens, Austin, Aventura, Bakersfield, Baltimore, Bellingham, Birmingham, Boise, Chevy Chase, Colorado Springs, Columbus, Denver, El Paso, Evansville, Farmington, Glenview, Greenacres City, Greenfield, Lancaster, Lincoln, Litchfield Park, Little Rock, Little Silver, Miami, North Charleston, North Little Rock, Oklahoma City, Owensboro, Pittsburgh, Plainfield, Redwood City, River Forest, San Antonio, Sandy City, Sarasota, Savannah, Seattle, St Louis, Tallahassee, Toledo, and Tulsa, United StatesSee the 43 sitesAlso in 29 other countries, 141 sites
Status
Active, not recruiting
Phase
Phase 3
People taking part
696 people enrolled
Started
9 Dec 2022
Expected to end
2 Aug 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • LOU064 (blinded)
  • Placebo
  • LOU064 (open label)
Record updated
11 March 2026

Who can take part

Age
18 years to 100 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Requirement for anticoagulant medication
  • Significant bleeding risk or coagulation disorders
  • History of gastrointestinal bleeding
  • 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
  • Requirement for anti-platelet medication

Where in United States

Also in 29 other countries, 141 sites

  • Oakview DermatologyAthens, United States
  • Orion Clinical ResearchAustin, United States
  • Florida Ctr Allergy Asthma ResearchAventura, United States
  • Kern ResearchBakersfield, United States
  • John Hopkins UniversityBaltimore, United States
  • Bellingham Asthma Allergy and ImmunologyBellingham, United States
  • AllerVie Clinical ResearchBirmingham, United States
  • Cahaba Derm and skin hlth ctr 27Birmingham, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Institute for Asthma and Allergy PCChevy Chase, United States
  • Asthma and Allergy Associates P CColorado Springs, United States
  • CR Services Acquisition USColumbus, United States
  • Optimed Research LLCColumbus, United States
  • Colorado Allergy and Asthma Ctr PCDenver, United States
  • Western Sky Medical ResearchEl Paso, United States
  • Deaconess Clin Allerg Res InstEvansville, United States
  • UCONN Health DermatologyFarmington, United States
  • Endeavor HealthGlenview, United States
  • Finlay Medical ResearchGreenacres City, United States
  • Allergy Asthma and amp Sinus Ctr S CGreenfield, United States
  • Antelope Valley Clinical TrialsLancaster, United States
  • Somnos Clinical ResearchLincoln, United States
  • Research Solutions of ArizonaLitchfield Park, United States
  • Acuro Research, IncLittle Rock, United States
  • Allergy Asthma Assoc MonmouthLittle Silver, United States
  • Miami Dade Medical ResearchMiami, United States
  • National Allergy and Asthma Research LLSNorth Charleston, United States
  • Arkansas Research TrialsNorth Little Rock, United States
  • Allergy, Asthma and Clinical ResearchOklahoma City, United States
  • Allergy and Asthma Specialist P S COwensboro, United States
  • Allergy and Clinical Immunology AssociatesPittsburgh, United States
  • The Indiana Clinical Trials CenterPlainfield, United States
  • Allergy and Asthma ConsultantsRedwood City, United States
  • Asthma and Allergy Center of Chicago S CRiver Forest, United States
  • RFSA DermatologySan Antonio, United States
  • Allergy Associates of UtahSandy City, United States
  • Sarasota Clinical ResearchSarasota, United States
  • Aeroallergy Research LaboratoriesSavannah, United States
  • Seattle Allergy and Asthma RschSeattle, United States
  • The Clinical Research CenterSt Louis, United States
  • Allergy and Asthma Diagnostic Treatment CenterTallahassee, United States
  • Toledo Institute of Clinical ResearchToledo, United States
  • Vital Prospects Clinical Research InstituteTulsa, United States

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Arm 1: LOU064 (blinded)Treatment being tested

    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)

    Treatment: LOU064 (blinded) and LOU064 (open label)

  • Arm 2: LOU064 Placebo (blinded)Placebo, for comparison

    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)

    Treatment: Placebo and LOU064 (open label)

  • Arm 3: LOU064 (Open Label)Treatment being tested

    LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)

    Treatment: LOU064 (open label)

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Record updated
11 March 2026