AzTrials
AzTrials

Chronic Spontaneous UrticariaPhase 3NCT06042478

Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

A Phase 3 study testing Remibrutinib and Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 110 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU)… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
Remibrutinib and Omalizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
470 participants
Where
110 sitesin 23 countries
Study dates
15 Nov 2023to 20 Jul 2027
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female adult participants ≥18 years of age at the time of signing the informed consent.
  • CSU duration for ≥ 6 months prior to screening.
  • Diagnosis of CSU inadequately controlled by second generation H1-AH 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-AH 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.
  • 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).

Who cannot join

  • Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
  • Significant bleeding risk or coagulation disorders.
  • History of gastrointestinal bleeding.
  • Requirement for anti-platelet or anti-coagulant 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.
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  • Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines.
  • Documented history of anaphylaxis.
  • Pregnant or nursing (lactating) women.

Trial locations and contacts

110 sites in 23 countries.

110 sites in 23 countries

Germany19 sites

  • Novartis Investigative Site

    Bad Bentheim, 48455

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bochum, 44793

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 22391

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Stade, Lower Saxony, 21682

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

India11 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380016

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001

  • Novartis Investigative Site

    Hyderabad, Telangana, 500004

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440015

  • Novartis Investigative Site

    Nashik, Maharashtra, 422101

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

Other trials in India

Spain8 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Las Palmas GC, 35010

  • Novartis Investigative Site

    Valencia, 46015

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Canada7 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1C3

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 3C3

  • Novartis Investigative Site

    Hamilton, Ontario, L8S 1G5

  • Novartis Investigative Site

    London, Ontario, N6H 5L5

  • Novartis Investigative Site

    Niagara Falls, Ontario, L2H 1H5

  • Novartis Investigative Site

    Québec, Quebec, G1V 4W2

  • Novartis Investigative Site

    Verdun, Quebec, H4G 3E7

Other trials in Canada

Malaysia7 sites

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450

  • Novartis Investigative Site

    Ipoh, Perak, 30450

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Muar town, Johor, 84000

  • Novartis Investigative Site

    Petaling Jaya, Selangor, 46150

  • Novartis Investigative Site

    Wilayah Persekutuan, 62502

Other trials in Malaysia

Argentina6 sites

  • Novartis Investigative Site

    Bahía Blanca, B8000JRB

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    CABA, C1012AAY

  • Novartis Investigative Site

    Capital Federal, C1023AAB

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500AFD

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

Other trials in Argentina

France5 sites

  • Novartis Investigative Site

    Grenoble, 38043

  • Novartis Investigative Site

    La Rochelle, 17019

  • Novartis Investigative Site

    Nice, France, 06000

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Rouen, 76031

Other trials in France

Italy5 sites

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Roma, RM, 00186

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Siena, SI, 53100

Other trials in Italy

Thailand5 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110

Other trials in Thailand

Turkey (Türkiye)5 sites

  • Novartis Investigative Site

    Aydin, Efeler, 09100

  • Novartis Investigative Site

    Denizli, Kinikli, 20070

  • Novartis Investigative Site

    Istanbul, Fatih, 34093

  • Novartis Investigative Site

    Istanbul, Fatih, 34098

  • Novartis Investigative Site

    Sakarya, Adapazari, 54290

Other trials in Turkey (Türkiye)

Brazil4 sites

  • Novartis Investigative Site

    Alphaville Barueri, São Paulo, 06454-010

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90560-032

  • Novartis Investigative Site

    Santo André, São Paulo, 09060-870

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Mexico4 sites

  • Novartis Investigative Site

    Cuauhtémoc, Mexico City, 06100

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44638

  • Novartis Investigative Site

    Mérida, Yucatán, 97070

  • Novartis Investigative Site

    Villahermosa, Tabasco, 86035

Other trials in Mexico

Slovakia4 sites

  • Novartis Investigative Site

    Bardejov, 085 01

  • Novartis Investigative Site

    Kežmarok, 060 01

  • Novartis Investigative Site

    Svidník, 089 01

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02

Other trials in Slovakia

Bulgaria3 sites

  • Novartis Investigative Site

    Sofia, 1421

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Varna, 9009

Other trials in Bulgaria

Czechia3 sites

  • Novartis Investigative Site

    Brno, 602 00

  • Novartis Investigative Site

    Plzen Bolevec, 323 00

  • Novartis Investigative Site

    Prague, 100 34

Other trials in Czechia

Poland3 sites

  • Novartis Investigative Site

    Gdansk, 80-214

  • Novartis Investigative Site

    Gdansk, 80-546

  • Novartis Investigative Site

    Krosno, Krosno, 38-400

Other trials in Poland

South Korea3 sites

  • Novartis Investigative Site

    Ansan, Gyeonggi-do, 15355

  • Novartis Investigative Site

    Busan, 49241

  • Novartis Investigative Site

    Seoul, 03722

Other trials in South Korea

Taiwan2 sites

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Vietnam2 sites

  • Novartis Investigative Site

    Hanoi, Vietnam, 100000

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

Hungary1 site

  • Novartis Investigative Site

    Kaposvár, 7400

Other trials in Hungary

Netherlands1 site

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland1 site

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

United Kingdom1 site

  • Novartis Investigative Site

    Birmingham, B9 5SS

Other trials in United Kingdom

About this study

Official title: A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines and an Open-label 52-week Optional Extension to Assess Long-term Efficacy, Safety and Tolerability of Remibrutinib 25 mg b.i.d.

The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.

Read the detailed description

The study consists of 4 periods, and the total study duration is up to 112 weeks. Approximately 468 adult participants with CSU are expected to be randomized in the study.

Screening period: A screening period of up to 4 weeks will allow for the assessment of eligibility, determination of baseline disease activity and wash-out of prohibited medications.

Core Phase Treatment Period (52 weeks):

The treatment period will be double-dummy and double-blind, with placebo injections matching omalizumab 300 mg s.c. given to participants in the remibrutinib arm and placebo tablets matching remibrutinib 25 mg given to participants in the omalizumab arm (double-dummy). At the randomization visit, eligible participants will be randomized to one of four treatment arms.

Extension Phase Treatment Period (52 weeks): Optional open-label extension where patients receive treatment with open-label remibrutinib 25 mg, for 52 weeks.

Follow-up period:

For patients that do not enter the extension phase, there will be a 16-week, treatment-free, safety follow-up period.

Patients that enter extension phase will have a 4-week treatment-free safety follow-up period at the end of the extension phase.

All participants will be on a stable, local label-approved standard dose of a second-generation H1-AH ("background therapy") throughout the entire core phase (starting a minimum of 7 days prior to randomization until the end of the core phase).

In addition, to treat unbearable symptoms of CSU flare-ups, participants will be allowed to use a different second-generation H1-AH on an as-needed basis ("rescue therapy").

Being tested
Remibrutinib, Placebo to remibrutinib, Placebo to omalizumab, Omalizumab
Keywords
CSU, urticaria, LOU064, omalizumab, remibrutinib
Medical subject headings
Chronic Urticaria, Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemibrutinibDrug

    Active treatment

  • Placebo to remibrutinibDrug

    Placebo followed by active treatment

  • Placebo to omalizumabDrug

    Placebo followed by active comparator

  • OmalizumabDrug

    Active comparator

Study groups in NCT06042478
Study groupRoleWhat they receive
RemibrutinibExperimentalParticipants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.
Receives: Drug: Remibrutinib
Placebo to remibrutinibPlacebo comparatorParticipants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w.
Receives: Drug: Placebo to remibrutinib
Placebo to omalizumabPlacebo comparatorParticipants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d.
Receives: Drug: Placebo to omalizumab
OmalizumabActive comparatorparticipants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.
Receives: Drug: Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline in Weekly Urticaria Activity Score (UAS7)

    The UAS7 is the sum of the Weekly Hives Severity Score (HSS7 score) and the Weekly Itch Severity Score (ISS7 score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).

    Measured: Week 12

Secondary outcomes (4)

  1. Achievement of UAS7=0 (yes/no)

    Complete UAS7 response is UAS7 = 0

    Measured: Week 12

  2. Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score

    The severity of the itch will be recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.

    Measured: Week 12

  3. Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score

    The hives (wheals) severity score, defined by number of hives, will be recorded by the participant twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.

    Measured: Week 12

  4. Occurrence of treatment-emergent adverse events and serious adverse events (SAEs)

    To demonstrate the safety and tolerability of remibrutinib (25 mg b.i.d.)

    Measured: up to 68 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start15 Nov 2023
  3. Primary completion17 Sep 2025
  4. Study completion20 Jul 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomized to 1 of 4 treatment arms in a 2:1:1:2 ratio: * Remibrutinib 25 mg b.i.d. arm: participants receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks * Placebo to remibrutinib arm: participants receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w. * Placebo to omalizumab arm: participants receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. * Omalizumab 300 mg every 4 weeks arm: participants receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks. All of the above arms are followed by an optional 52-week extension period where participants receive treatment with remibrutinib 25 mg b.i.d. for 52 weeks.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06042478
Sponsor's protocol ID
CLOU064A2304
Other IDs
2022-502161-19-00
Status last verified
Oct 2026
First submitted
7 Sep 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

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 110 sites in 23 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 9 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: under way, not looking for participants, as of the sponsor's last update on 14 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 110 sites in Germany, India, Spain, Canada, Malaysia and 18 more countries. 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06042478.

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 14 Oct 2026.

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