Chronic Spontaneous UrticariaPhase 3NCT07816328
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
A Phase 3 study testing Remibrutinib and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Remibrutinib and Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 21 Sep 2026to 24 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults (age ≥18 years) at the time of signing the informed consent.
- CSU duration for ≥2 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 sgH1-AH at baseline defined as:
- The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgH1-AH during this time period.
- UAS7 score (range: 0-42) ≥16.
- Documentation of hives within two months prior to baseline (either at screening and/or at baseline; or documented in the participant's 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 enrollment (Day 1).
Who cannot join
- Previous use of remibrutinib, other Bruton's tyrosine kinase (BTK) inhibitors or prior exposure to biologics with any effect in CSU (e.g., ligelizumab, omalizumab, dupilumab, barzolvolimab).
- 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, gastrointestinal, or hematological disorders, 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 by the participant.
- Significant bleeding risk or coagulation disorders.
- History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion).
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75mg/d. 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- Coagulant - 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 1.5x upper limit of normal (ULN) or international normalized ratio (INR) of more than 1.5 at screening.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
5 sites in 3 countries
Japan3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Kamimashi-gun, Kumamoto, 8613106
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 2206208
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 2400013
Hong Kong1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
South Korea1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
About this study
Official title: A Global, Multi-center, Open-label Study, Investigating a Remibrutinib- and Omalizumab-Based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-Antihistamines, to Achieve Fast and Well-Controlled Disease Within 24 Weeks
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).
Read the detailed description
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.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Remibrutinib, Omalizumab
- Keywords
- LOU064, CSU, Treatment algorithm, UAS7, UCT7, sgH1-AH, omalizumab, remibrutinib
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Also called LOU064
Remibrutinib 25 mg twice a day.
OmalizumabDrug
Omalizumab 300 mg every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib | Experimental | Participants will receive remibrutinib 25 mg twice a day for 12 weeks. Receives: Drug: Remibrutinib |
| Remibrutinib or Omalizumab | Experimental | 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. Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 16, 20, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start21 Sep 2026
- Primary completion24 May 2028 (estimated)
- Study completion24 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816328
- Sponsor's protocol ID
- CLOU064A2307
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global, Multi-center, Open-label Study, Investigating a Remibrutinib- and Omalizumab-Based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-Antihistamines, to Achieve Fast and Well-Controlled Disease Within 24 Weeks
- ClinicalTrials.gov ID
- NCT07816328
- Acronym / sponsor ID
- CLOU064A2307
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- LOU064, CSU, Treatment algorithm, UAS7, UCT7, sgH1-AH, omalizumab, remibrutinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 24 May 2028 (estimated)
- Study completion
- 24 May 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remibrutinib | Experimental | Drug: RemibrutinibParticipants will receive remibrutinib 25 mg twice a day for 12 weeks. |
| Remibrutinib or Omalizumab | Experimental | Drug: OmalizumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female adults (age ≥18 years) at the time of signing the informed consent.
- CSU duration for ≥2 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 sgH1-AH at baseline defined as:
- Documentation of hives within two months prior to baseline (either at screening and/or at baseline; or documented in the participant's 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.
Key exclusion criteria (8 listed)
- Previous use of remibrutinib, other Bruton's tyrosine kinase (BTK) inhibitors or prior exposure to biologics with any effect in CSU (e.g., ligelizumab, omalizumab, dupilumab, barzolvolimab).
- 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, gastrointestinal, or hematological disorders, 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 by the participant.
- Significant bleeding risk or coagulation disorders.
- History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion).
- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemibrutinibAlso: LOU064Remibrutinib 25 mg twice a day. | Drug | Remibrutinib |
| OmalizumabOmalizumab 300 mg every 4 weeks. | Drug | Remibrutinib or Omalizumab |
Primary outcome
Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no)
Time frame: Week 24
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.
7 secondary outcomes
Proportion of participants achieving UAS7 ≤6 (yes/no)
Time frame: Weeks 16 and 20
Proportion of participants achieving UAS7 =0 (yes/no)
Time frame: Weeks 16, 20, and 24
Proportion of participants achieving Angioedema Activity Score over 7 days (AAS7) =0.
Time frame: Weeks 16, 20, and 24
Proportion of participants achieving of Dermatology Life Quality Index (DLQI) =0/1
Time frame: Weeks 16, 20, and 24
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
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.
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.
Time frame: Weeks 16, 20, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remibrutinib and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan, Hong Kong, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.