A Phase 3 interventional study of Remibrutinib and Omalizumab in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Recruiting at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).
This is a global, multi-center, open-label study, investigating a remibrutinib- and omalizumab-based treatment algorithm in adult patients with CSU inadequately controlled by sgH1-AH, to achieve fast and well-controlled disease within 24 weeks.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's planned enrollment of 382 is above the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Diagnosis of CSU inadequately controlled by sgH1-AH at baseline defined as:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive remibrutinib 25 mg twice a day for 12 weeks.
Drug: Remibrutinib
Participants will receive remibrutinib 25 mg twice a day. At Week 12, well-controlled participants (UCT7 ≥12) continue remibrutinib, while participants with inadequate control (UCT7 \<12) escalate to omalizumab 300 mg every 4 weeks.
Drug: Omalizumab
Remibrutinib 25 mg twice a day.
Also known as: LOU064
Omalizumab 300 mg every 4 weeks.
Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no)
UAS7 is a validated patient-reported measure of chronic spontaneous urticaria disease activity over 7 days. It is calculated as the sum of the weekly Hives Severity Score (HSS7) and the weekly Itch Severity Score (ISS7) and ranges from 0 to 42. Lower scores indicate lower disease activity / better disease control, and a score of ≤6 indicates well-controlled disease. HSS7 and ISS7 are each derived from daily diary entries over the 7 days preceding the visit.
Time frame: Week 24
Proportion of participants achieving UAS7 ≤6 (yes/no)
UAS7 is calculated as the sum of the HSS7 and ISS7 and ranges from 0 to 42. Lower scores indicate lower disease activity / better disease control, and a score of ≤6 indicates well-controlled disease. HSS7 and ISS7 are each derived from daily diary entries over the 7 days preceding the visit.
Time frame: Weeks 16 and 20
Proportion of participants achieving UAS7 =0 (yes/no)
UAS7 is calculated as the sum of the HSS7 and ISS7 and ranges from 0 to 42, with 0 indicating no urticaria activity over the 7-day assessment period and higher scores indicating worse disease activity.
Time frame: Weeks 16, 20, and 24
Proportion of participants achieving Angioedema Activity Score over 7 days (AAS7) =0.
AAS7 is a validated tool assessing angioedema activity, recorded once daily in the evening in the eDiary. If no angioedema is reported on a given day, the daily score is 0. Weekly AAS7 scores range from 0 to 105, with higher scores indicating greater angioedema severity; therefore, 0 represents absence of angioedema.
Time frame: Weeks 16, 20, and 24
Proportion of participants achieving of Dermatology Life Quality Index (DLQI) =0/1
DLQI is a 10-item dermatology-specific quality-of-life instrument assessing the impact of skin disease over the previous 7 days. The total score ranges from 0 to 30, with higher scores indicating worse disease-related quality of life. A score of 0-1 corresponds to no effect on the participant's life.
Time frame: Weeks 16, 20, and 24
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
To evaluate the safety and tolerability of LOU064.
Time frame: From Day 1 until at least 4 weeks after the last administration of remibrutinib and at least 16 weeks after the last administration of omalizumab
Proportion of participants achieving UAS7 ≤6 under the treatment algorithm compared with historical omalizumab (300 mg every 4 weeks) data.
UAS7 is calculated as the sum of the HSS7 and ISS7 and ranges from 0 to 42. Lower scores indicate lower disease activity / better disease control, and a score of ≤6 indicates well-controlled disease. HSS7 and ISS7 are each derived from daily diary entries over the 7 days preceding the visit.
Time frame: Weeks 16, 20, and 24
Proportion of participants achieving UAS7 =0 under the treatment algorithm compared with historical omalizumab (300 mg every 4 weeks) data.
UAS7 is calculated as the sum of the HSS7 and ISS7 and ranges from 0 to 42, with 0 indicating no urticaria activity over the 7-day assessment period and higher scores indicating worse disease activity.
Time frame: Weeks 16, 20, and 24
Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Remibrutinib