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

NCT05513001

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Chronic Spontaneous Urticaria

Interventions: LOU064 (blinded), Placebo, LOU064 (open label)

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Colombia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

* 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.
Locations (208)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Litchfield Park, Arizona, United States
  • Little Rock, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • Bakersfield, California, United States
  • Lancaster, California, United States
  • Redwood City, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Farmington, Connecticut, United States
  • Aventura, Florida, United States
  • Greenacres City, Florida, United States
  • Miami, Florida, United States
  • Sarasota, Florida, United States
  • Tallahassee, Florida, United States
  • Savannah, Georgia, United States
  • Boise, Idaho, United States
  • Glenview, Illinois, United States
  • River Forest, Illinois, United States
  • Evansville, Indiana, United States
  • Plainfield, Indiana, United States
  • Owensboro, Kentucky, United States
  • Baltimore, Maryland, United States
  • Chevy Chase, Maryland, United States
  • St Louis, Missouri, United States
  • Lincoln, Nebraska, United States
  • Little Silver, New Jersey, United States
  • Athens, Ohio, United States
  • Columbus, Ohio, United States
  • + 178 more on CT.gov