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.
NCT ID: NCT06042478
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
471 participants
INTERVENTIONAL
2023-11-15
2027-07-20
Brief Summary
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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.
Detailed Description
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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").
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
TRIPLE
Study Groups
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Remibrutinib
Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.
Remibrutinib
Active treatment
Placebo to remibrutinib
Participants 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.
Placebo to remibrutinib
Placebo followed by active treatment
Placebo to omalizumab
Participants 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.
Placebo to omalizumab
Placebo followed by active comparator
Omalizumab
participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.
Omalizumab
Active comparator
Interventions
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Remibrutinib
Active treatment
Placebo to remibrutinib
Placebo followed by active treatment
Placebo to omalizumab
Placebo followed by active comparator
Omalizumab
Active comparator
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
CABA, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Bahía Blanca, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Mendoza, , Argentina
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Porto Alegre, Rio Grande do Sul, Brazil
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Alphaville Barueri, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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Sorocaba, São Paulo, Brazil
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Québec, Quebec, Canada
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Verdun, Quebec, Canada
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Brno, , Czechia
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Plzen Bolevec, , Czechia
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Prague, , Czechia
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Grenoble, , France
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La Rochelle, , France
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Nice, , France
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Pierre-Bénite, , France
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Rouen, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Göttingen, Lower Saxony, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Bad Bentheim, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Bochum, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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München, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Stade, , Germany
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Tübingen, , Germany
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Kaposvár, , Hungary
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Belagavi, Karnataka, India
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Mysore, Karnataka, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Bikaner, Rajasthan, India
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Hyderabad, Telangana, India
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Dehradun, Uttarakhand, India
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Milan, MI, Italy
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Rozzano, MI, Italy
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Modena, MO, Italy
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Roma, RM, Italy
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Siena, SI, Italy
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Muar town, Johor, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Ipoh, Perak, Malaysia
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George Town, Pulau Pinang, Malaysia
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Petaling Jaya, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Wilayah Persekutuan, , Malaysia
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Guadalajara, Jalisco, Mexico
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Cuauhtémoc, Mexico City, Mexico
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Villahermosa, Tabasco, Mexico
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Mérida, Yucatán, Mexico
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Utrecht, , Netherlands
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Gdansk, , Poland
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Gdansk, , Poland
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Krosno, , Poland
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Poznan, , Poland
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Bardejov, , Slovakia
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Kežmarok, , Slovakia
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Svidník, , Slovakia
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Trnava, , Slovakia
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Ansan, Gyeonggi-do, South Korea
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Busan, , South Korea
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Seoul, , South Korea
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Granada, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Las Palmas GC, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Zurich, , Switzerland
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Songkhla, Hat Yai, Thailand
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Sakarya, Adapazari, Turkey (Türkiye)
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Aydin, Efeler, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Denizli, Kinikli, Turkey (Türkiye)
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Birmingham, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2022-502161-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLOU064A2304
Identifier Type: -
Identifier Source: org_study_id