Um estudo para avaliar a eficácia do remibrutinibe em comparação com o dupilumab nos primeiros pontos de tempo em adultos com urticária espontânea crônica inadequadamente controlada pela segunda geração H1-antihistamines (RECLAIM)
Um estudo dos EUA de fase 3b, multicêntrico, randomizado, duplo e duplo e duplo para avaliar a eficácia do remibrutinibe em comparação com o dupilumab em pontos de tempo iniciais em adultos com urticária espontânea crônica inadequadamente controlada pela segunda geração H1-anti-histaminas
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Visão geral do estudo
Status
Condições
Descrição detalhada
This study consists of a screening period (up to 4 weeks), a core treatment period (12 weeks double-blind, double-dummy), an optional open-label extension [OLE] period, and safety follow-up period.
Screening period: participants will have a screening period of a minimum of 7 days up to a maximum of 28 days to establish eligibility for the study. Participants meeting all the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.
Core treatment period (double-blind, double-dummy): approximately, 400 participants diagnosed with CSU inadequately controlled by sgH1-AH will be randomized in this study. Participants will be stratified based on prior exposure to anti-IgE biologics.
Eligible participants will be randomized in a 1:1 ratio to receive remibrutinib and placebo solution for injection or dupilumab and remibrutinib matching placebo, both as an add-on treatment to once daily standard label dose of sgH1-AH background therapy, until the Week 12 visit.
Additionally, all participants will be on a stable, standard label dose of a sgH1-AH ("background therapy") throughout the entire core treatment period (starting a minimum of 7 days prior to randomization until the end of Week 12). To treat unbearable symptoms of CSU, participants will be allowed to add more of the same sgH1-AH on an as-needed basis ("rescue therapy"). The total maximum daily dose of sgH1-AH (background plus rescue) should not exceed 4 tablets/day (4-fold the standard label dose).
Optional open-label extension [OLE] period: At the end of the 12-week double-blind treatment period, and in case remibrutinib is not commercially available, participants from both arms will be given the choice to roll over into an optional OLE safety period and receive remibrutinib (25 mg b.i.d. p.o.) for 12 weeks (up to Week 24).
Safety follow-up period:
- For participants who do not enter the OLE period: there will be a safety follow-up for 12 weeks with safety follow-up phone calls at Week 16 and Week 24 (Week 24 will be end of study).
- For participants who enter the OLE period: there will be 2 options at the end of Week 24:
- If remibrutinib is commercially available: participants will discontinue study treatment, perform their EOT visit and receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).
- If remibrutinib is not commercially available, participants may continue on remibrutinib 25 mg b.i.d. until its commercial availability and return for site visits for safety follow up and treatment dispensation every 3 months. When remibrutinib becomes commercially available, the participant will be contacted for a site visit to complete the EOT visit and will receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Allervie Clinical Research
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Birmingham, Alabama, Estados Unidos, 35244
- Cahaba Derm and skin hlth ctr 27
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Arizona
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Litchfield Park, Arizona, Estados Unidos, 85340
- Research Solutions of Arizona
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Payson, Arizona, Estados Unidos, 85541
- Peak Dermatology
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Phoenix, Arizona, Estados Unidos, 85032
- Premier Allergy Asthma And Immunology
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Scottsdale, Arizona, Estados Unidos, 85254
- Orso Health
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Acuro Research Inc
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California
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Fountain Valley, California, Estados Unidos, 92708
- First OC Dermatology
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Fremont, California, Estados Unidos, 95438
- Ctr for Dermatology Clinical Res
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Huntington Beach, California, Estados Unidos, 92647
- Allergy and Asthma Specialists Group
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Long Beach, California, Estados Unidos, 90808
- Orso Health
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Long Beach, California, Estados Unidos, 90815
- Ark Clinical Research
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Los Angeles, California, Estados Unidos, 90045
- Dermatology Research Associates
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Los Angeles, California, Estados Unidos, 90025
- California Allergy and Asthma Medical Group
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Napa, California, Estados Unidos, 94558
- One Of A Kind Clinical Research
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Palo Alto, California, Estados Unidos, 94304
- Stanford University Medical Center
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Pomona, California, Estados Unidos, 91767
- Empire Clinical Research
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Redwood City, California, Estados Unidos, 94063
- Allergy and Asthma Consultants
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Rocklin, California, Estados Unidos, 95765
- Norcal Clinical Research
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Rolling Hills Estates, California, Estados Unidos, 90274
- Peninsula Research Associates
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Sacramento, California, Estados Unidos, 95815
- Integrative Skin Science and Res
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Sacramento, California, Estados Unidos, 95817
- UC Davis Neuromuscular Research Center
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San Diego, California, Estados Unidos, 92123
- Therapeutics Clinical Research
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Santa Monica, California, Estados Unidos, 90403
- Dermatology Institute and Skin Care
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Upland, California, Estados Unidos, 91786
- Integrated Research of Inland Inc
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Walnut Creek, California, Estados Unidos, 94598
- Allergy and Asthma Clin Res Inc
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Hospital - Aurora
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Colorado Springs, Colorado, Estados Unidos, 80909
- Colorado ENT and Allergy
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Colorado Springs, Colorado, Estados Unidos, 80907
- Asthma and Allergy Associates P C
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20059
- Howard University Hospital Division of Geriatrics
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Florida
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Aventura, Florida, Estados Unidos, 33180
- Florida Ctr Allergy Asthma Research
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Boca Raton, Florida, Estados Unidos, 33486
- Skin Care Research Inc
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Doral, Florida, Estados Unidos, 33172
- Omnicure Clinical Research
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Fort Lauderdale, Florida, Estados Unidos, 33308
- FXM Clinical Research Ft Laud
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Hollywood, Florida, Estados Unidos, 33021
- Skin Care Research LLC
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Jacksonville, Florida, Estados Unidos, 32216
- Jacksonville Center for Clinical Research
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Miami, Florida, Estados Unidos, 33176
- Miami Dade Medical Research
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Miami, Florida, Estados Unidos, 33125
- University of MiamiHealth System
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Miami, Florida, Estados Unidos, 33175
- FXM Clinical Res Miami LLC
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Miramar, Florida, Estados Unidos, 33027
- Eminat LLC
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North Miami Beach, Florida, Estados Unidos, 33162
- Ziaderm Research LLC
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Panama, Florida, Estados Unidos, 32405
- AllerVie Health
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Sarasota, Florida, Estados Unidos, 34233
- Sarasota Clinical Research
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Sweetwater, Florida, Estados Unidos, 33172
- Lenus Research and Med Group LLC
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Tampa, Florida, Estados Unidos, 33613
- Asthma Allergy Immunology Clin Res
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Winter Park, Florida, Estados Unidos, 32789
- Conquest Research
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Georgia
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Columbus, Georgia, Estados Unidos, 31904
- AllerVie Clin Res Columbus GA
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Cumming, Georgia, Estados Unidos, 30040
- Cleaver Medical Group
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Douglasville, Georgia, Estados Unidos, 30135
- Southeast Dermatology Specialists
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Savannah, Georgia, Estados Unidos, 31406
- Aeroallergy Research Laboratories
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Idaho
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Meridian, Idaho, Estados Unidos, 83642
- The Allergy Group-Meridian Clinic
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60611
- NW Uni C and T Sciences Ins
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Normal, Illinois, Estados Unidos, 61761
- Midwest Allergy Sinus Asthma SC
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O'Fallon, Illinois, Estados Unidos, 62269
- Clinical Res Ctr of S Illinois
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River Forest, Illinois, Estados Unidos, 60305
- Asthma and Allergy Center of Chicago S C
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Skokie, Illinois, Estados Unidos, 60077
- Endeavor Health Clinical Trials Center
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Wheaton, Illinois, Estados Unidos, 60189
- Accellacare Duly Health and Care
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Indiana
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Evansville, Indiana, Estados Unidos, 47715
- Deaconess Clin Allerg Res Inst
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New Albany, Indiana, Estados Unidos, 47150
- Southern IN Clinical Trials
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic PC
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Kentucky
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Bowling Green, Kentucky, Estados Unidos, 42104
- Equity Medical LLC
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Louisville, Kentucky, Estados Unidos, 40215
- Family Allergy And Asthma Rsch Inst
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Owensboro, Kentucky, Estados Unidos, 42301
- Allergy and Asthma Specialist P S C
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70816
- Ochsner Health Center
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Lafayette, Louisiana, Estados Unidos, 70508
- Velocity Clinical Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21236
- Chesapeake Clinical Research Inc
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins U School of Med
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Chevy Chase, Maryland, Estados Unidos, 20815
- Institute for Asthma and Allergy PC
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Boston Specialists LLC
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106-0525
- ClinSite Inc
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Caledonia, Michigan, Estados Unidos, 49316
- Derm Institute West Michigan PLLC
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Troy, Michigan, Estados Unidos, 48084
- Somerset Skin Centre
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Troy, Michigan, Estados Unidos, 48084
- Revival Research Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55402
- Clinical Research Institute
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic - Rochester
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Missouri
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Columbia, Missouri, Estados Unidos, 65201
- ENT and Allergy Center of Missouri
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St Louis, Missouri, Estados Unidos, 63141
- The Clinical Research Center
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St Louis, Missouri, Estados Unidos, 63141
- Washington University
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68510
- Somnos Clinical Research
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89144
- Las Vegas Dermatology
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Las Vegas, Nevada, Estados Unidos, 89128
- Allergy and Asthma Center of Las Vegas
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New Jersey
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Hamilton, New Jersey, Estados Unidos, 08619
- Circuit Clinical Mercer Algy Pulm
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Little Silver, New Jersey, Estados Unidos, 07739
- Allergy Asthma Assoc Monmouth
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Ocean Township, New Jersey, Estados Unidos, 07712
- Allergy Partners of New Jersey PC
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New York
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The Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
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The Bronx, New York, Estados Unidos, 10455
- Equity Medical
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28801
- Allergy Partners Of West NC
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Chapel Hill, North Carolina, Estados Unidos, 27516
- UNC DermatologyandSkinCancer Ctr
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45231
- Bernstein Clinical Research Center
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Columbus, Ohio, Estados Unidos, 43213
- CR Services Acquisition US
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Fairborn, Ohio, Estados Unidos, 45324
- Wright State University
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Toledo, Ohio, Estados Unidos, 43617
- Toledo Institute of Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73118
- Unity Clinical Research
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Tulsa, Oklahoma, Estados Unidos, 74136
- Vital Prospects Clinical Research Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health Sciences University
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Portland, Oregon, Estados Unidos, 97223
- Oregon Medical Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15241
- Allergy and Clinical Immunology Associates
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Allergic Disease and Asthma Center
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Greenville, South Carolina, Estados Unidos, 29601
- Tribe Clinical Research LLC
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North Charleston, South Carolina, Estados Unidos, 29420
- National Allergy and Asthma Research LLS
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North Charleston, South Carolina, Estados Unidos, 29406
- Charleston ENT and Allergy
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Tennessee
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Goodlettsville, Tennessee, Estados Unidos, 37072-2301
- Goodlettsville Dermatology Research
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Murfreesboro, Tennessee, Estados Unidos, 37130
- International Clinical Research Tennessee LCC
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Texas
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Arlington, Texas, Estados Unidos, 76011
- Arlington Center for Dermatology
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Austin, Texas, Estados Unidos, 78759
- Orion Clinical Research
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Bellaire, Texas, Estados Unidos, 77401
- Bellaire Dermatology Associates
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Dallas, Texas, Estados Unidos, 75230
- Reveal Research Institute
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Dallas, Texas, Estados Unidos, 75231
- Pharma Research and Amp Consult
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El Paso, Texas, Estados Unidos, 79924
- Western Sky Medical Research
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Houston, Texas, Estados Unidos, 77030
- Center for Clinical Studies
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Kerrville, Texas, Estados Unidos, 78028
- Sante Clinical Research
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San Antonio, Texas, Estados Unidos, 78229
- Andante Research
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San Antonio, Texas, Estados Unidos, 78213
- RFSA Dermatology
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Utah
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Murray, Utah, Estados Unidos, 84107
- University Of Utah
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Sandy City, Utah, Estados Unidos, 84093
- Allergy Associates of Utah
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Virginia
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Vienna, Virginia, Estados Unidos, 22182
- Forefront Dermatology
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Washington
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Bellingham, Washington, Estados Unidos, 98225
- Bellingham Asthma Allergy and Immunology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults ≥ 18 years of age at the time of signing the informed consent
- CSU duration for ≥ 6 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 the time of randomization, defined as:
- The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):
- UAS7 score (range, 0-42) ≥ 16, and
- ISS7 score (range, 0-21) ≥ 6, and
- HSS7 score (range, 0-21) ≥ 6
- Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants 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 randomization (Day 1)
Exclusion Criteria:
- Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
- Previous use of dupilumab
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, 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 hematological disorders (including coagulation disorders or significant bleeding risk)
- History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), 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 75 mg/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-Coagulants [NOAC])
- History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) > 1.5 at screening
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treatment group 1: Remibrutinib + Placebo
Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week [Weeks 2-10]) |
Film-coated tablet, oral administration, 25 mg b.i.d. Solution for injection in pre-filled syringe every 2 weeks |
|
Comparador Ativo: Treatment group 2: Dupilumab + remibrutinib matching placebo
Dupilumab pre-filled syringe (600 mg loading dose [2 x 300 mg dupilumab s.c. injection] at baseline visit followed by dupilumab 300 mg s.c. injection every other week [Weeks 2-10]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.) |
Film-coated tablet, oral administration, b.i.d. Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
Prazo: Baseline, Week 4
|
The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit. |
Baseline, Week 4
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4
Prazo: Baseline, Week 4
|
The hives (wheals) severity score, defined by number of hives, will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3. 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. |
Baseline, Week 4
|
|
Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 4
Prazo: Baseline, Week 4
|
The severity of the itch will be recorded by the participant twice daily in their eCOA device, 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. |
Baseline, Week 4
|
|
Improvement of UAS7, assessed as absolute change from baseline in UAS7 score at Week 1
Prazo: Baseline, Week 1
|
The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit. |
Baseline, Week 1
|
|
Percentage of participants with UAS7 ≤ 6 at Week 4
Prazo: Week 4
|
Percentage of participants who achieved UAS7 ≤ 6 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit. |
Week 4
|
|
Percentage of participants with UAS7=0 at Week 4
Prazo: Week 4
|
Percentage of participants who achieved UAS7 = 0 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit. |
Week 4
|
|
Percentage of participants with UAS7 ≤ 6 at Week 2
Prazo: Week 2
|
Percentage of participants who achieved UAS7 ≤ 6 at Week 2. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit. |
Week 2
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Doenças do sistema imunológico
- Hipersensibilidade, Imediata
- Hipersensibilidade
- Doenças de pele
- Urticária
- Doenças de Pele, Vasculares
- Condições Patológicas, Sinais e Sintomas
- Doenças da Pele e do Tecido Conjuntivo
- Urticária Crônica
- Terapêutica
- Rotas de administração de medicamentos
- Terapia medicamentosa
- Injeções
- dupilumab
- RUNIBRUTINIB
Outros números de identificação do estudo
- CLOU064AUS02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .