A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria

In brief

The purpose of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Key facts

Study ID

NCT05030311

Run by

Novartis Pharmaceuticals

People needed

470

Starts

2021-11-30

Expected to finish

2024-01-19

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study.
• Male and female adult participants ≥18 years of age.
• CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
• Diagnosis of CSU inadequately controlled by second generation H1 antihistamines at the time of randomization defined as:
• The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period
• UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to randomization (Day 1)
• Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants medical history).
• Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
• Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).

You may not qualify if…

• Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
• Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
• Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
• Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), 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
• Significant bleeding risk or coagulation disorders
• History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion)
• Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.
• Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))
• History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — North Little Rock, Arkansas, United States
• Novartis Investigative Site — Bakersfield, California, United States
• Novartis Investigative Site — Lancaster, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Redwood City, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Aventura, Florida, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Albany, Georgia, United States
• Novartis Investigative Site — Woodstock, Georgia, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Chevy Chase, Maryland, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Athens, Ohio, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Toledo, Ohio, United States
• Novartis Investigative Site — Tulsa, Oklahoma, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — El Paso, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Antony, France

Full record on ClinicalTrials.gov

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