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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.
Sponsor: Novartis Pharmaceuticals
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) 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.
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.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
470
Start Date
2023-11-15
Completion Date
2027-07-20
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Remibrutinib
Active treatment
Placebo to remibrutinib
Placebo followed by active treatment
Placebo to omalizumab
Placebo followed by active comparator
Omalizumab
Active comparator
Locations (111)
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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Stade, 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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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