- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06868212
만성 자발적 두드러기가있는 성인의 초기 시점에서 Dupilumab과 비교하여 Remibrutinib의 효능을 평가하는 연구는 2 세대 H1- 안티시스타민; (RECLAIM)
미국 단계 3B, 다중 센터, 무작위, 이중 맹검, 이중 더미 연구는 2 세대 H1- 안티시스타민사에 의해 만성 자발적 두드러기를 가진 성인의 초기 시계에서 Dupilumab과 비교하여 remibrutinib의 효능을 평가합니다.
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35209
- Allervie Clinical Research
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Birmingham, Alabama, 미국, 35244
- Cahaba Derm and skin hlth ctr 27
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Arizona
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Litchfield Park, Arizona, 미국, 85340
- Research Solutions of Arizona
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Payson, Arizona, 미국, 85541
- Peak Dermatology
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Phoenix, Arizona, 미국, 85032
- Premier Allergy Asthma And Immunology
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Scottsdale, Arizona, 미국, 85254
- Orso Health
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- Acuro Research Inc
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California
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Fountain Valley, California, 미국, 92708
- First OC Dermatology
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Fremont, California, 미국, 95438
- Ctr for Dermatology Clinical Res
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Huntington Beach, California, 미국, 92647
- Allergy and Asthma Specialists Group
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Long Beach, California, 미국, 90808
- Orso Health
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Long Beach, California, 미국, 90815
- Ark Clinical Research
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Los Angeles, California, 미국, 90045
- Dermatology Research Associates
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Los Angeles, California, 미국, 90025
- California Allergy and Asthma Medical Group
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Napa, California, 미국, 94558
- One Of A Kind Clinical Research
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Palo Alto, California, 미국, 94304
- Stanford University Medical Center
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Pomona, California, 미국, 91767
- Empire Clinical Research
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Redwood City, California, 미국, 94063
- Allergy and Asthma Consultants
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Rocklin, California, 미국, 95765
- Norcal Clinical Research
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Rolling Hills Estates, California, 미국, 90274
- Peninsula Research Associates
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Sacramento, California, 미국, 95815
- Integrative Skin Science and Res
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Sacramento, California, 미국, 95817
- UC Davis Neuromuscular Research Center
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San Diego, California, 미국, 92123
- Therapeutics Clinical Research
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Santa Monica, California, 미국, 90403
- Dermatology Institute and Skin Care
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Upland, California, 미국, 91786
- Integrated Research of Inland Inc
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Walnut Creek, California, 미국, 94598
- Allergy and Asthma Clin Res Inc
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Hospital - Aurora
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Colorado Springs, Colorado, 미국, 80909
- Colorado ENT and Allergy
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Colorado Springs, Colorado, 미국, 80907
- Asthma and Allergy Associates P C
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20059
- Howard University Hospital Division of Geriatrics
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Florida
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Aventura, Florida, 미국, 33180
- Florida Ctr Allergy Asthma Research
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Boca Raton, Florida, 미국, 33486
- Skin Care Research Inc
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Doral, Florida, 미국, 33172
- Omnicure Clinical Research
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Fort Lauderdale, Florida, 미국, 33308
- FXM Clinical Research Ft Laud
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Hollywood, Florida, 미국, 33021
- Skin Care Research LLC
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Jacksonville, Florida, 미국, 32216
- Jacksonville Center for Clinical Research
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Miami, Florida, 미국, 33176
- Miami Dade Medical Research
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Miami, Florida, 미국, 33125
- University of MiamiHealth System
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Miami, Florida, 미국, 33175
- FXM Clinical Res Miami LLC
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Miramar, Florida, 미국, 33027
- Eminat LLC
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North Miami Beach, Florida, 미국, 33162
- Ziaderm Research LLC
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Panama, Florida, 미국, 32405
- AllerVie Health
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Sarasota, Florida, 미국, 34233
- Sarasota Clinical Research
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Sweetwater, Florida, 미국, 33172
- Lenus Research and Med Group LLC
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Tampa, Florida, 미국, 33613
- Asthma Allergy Immunology Clin Res
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Winter Park, Florida, 미국, 32789
- Conquest Research
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Georgia
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Columbus, Georgia, 미국, 31904
- AllerVie Clin Res Columbus GA
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Cumming, Georgia, 미국, 30040
- Cleaver Medical Group
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Douglasville, Georgia, 미국, 30135
- Southeast Dermatology Specialists
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Savannah, Georgia, 미국, 31406
- Aeroallergy Research Laboratories
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Idaho
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Meridian, Idaho, 미국, 83642
- The Allergy Group-Meridian Clinic
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush University Medical Center
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Chicago, Illinois, 미국, 60611
- NW Uni C and T Sciences Ins
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Normal, Illinois, 미국, 61761
- Midwest Allergy Sinus Asthma SC
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O'Fallon, Illinois, 미국, 62269
- Clinical Res Ctr of S Illinois
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River Forest, Illinois, 미국, 60305
- Asthma and Allergy Center of Chicago S C
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Skokie, Illinois, 미국, 60077
- Endeavor Health Clinical Trials Center
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Wheaton, Illinois, 미국, 60189
- Accellacare Duly Health and Care
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Indiana
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Evansville, Indiana, 미국, 47715
- Deaconess Clin Allerg Res Inst
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New Albany, Indiana, 미국, 47150
- Southern IN Clinical Trials
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Iowa
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Ames, Iowa, 미국, 50010
- McFarland Clinic PC
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Kentucky
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Bowling Green, Kentucky, 미국, 42104
- Equity Medical LLC
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Louisville, Kentucky, 미국, 40215
- Family Allergy And Asthma Rsch Inst
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Owensboro, Kentucky, 미국, 42301
- Allergy and Asthma Specialist P S C
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Louisiana
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Baton Rouge, Louisiana, 미국, 70816
- Ochsner Health Center
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Lafayette, Louisiana, 미국, 70508
- Velocity Clinical Research
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Maryland
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Baltimore, Maryland, 미국, 21236
- Chesapeake Clinical Research Inc
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins U School of Med
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Chevy Chase, Maryland, 미국, 20815
- Institute for Asthma and Allergy PC
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- Boston Specialists LLC
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Michigan
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Ann Arbor, Michigan, 미국, 48106-0525
- ClinSite Inc
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Caledonia, Michigan, 미국, 49316
- Derm Institute West Michigan PLLC
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital
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Troy, Michigan, 미국, 48084
- Somerset Skin Centre
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Troy, Michigan, 미국, 48084
- Revival Research Institute
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
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Minneapolis, Minnesota, 미국, 55402
- Clinical Research Institute
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic - Rochester
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Missouri
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Columbia, Missouri, 미국, 65201
- ENT and Allergy Center of Missouri
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St Louis, Missouri, 미국, 63141
- The Clinical Research Center
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St Louis, Missouri, 미국, 63141
- Washington University
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Nebraska
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Lincoln, Nebraska, 미국, 68510
- Somnos Clinical Research
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Nevada
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Las Vegas, Nevada, 미국, 89144
- Las Vegas Dermatology
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Las Vegas, Nevada, 미국, 89128
- Allergy and Asthma Center of Las Vegas
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New Jersey
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Hamilton, New Jersey, 미국, 08619
- Circuit Clinical Mercer Algy Pulm
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Little Silver, New Jersey, 미국, 07739
- Allergy Asthma Assoc Monmouth
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Ocean Township, New Jersey, 미국, 07712
- Allergy Partners of New Jersey PC
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New York
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The Bronx, New York, 미국, 10467
- Montefiore Medical Center
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The Bronx, New York, 미국, 10455
- Equity Medical
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North Carolina
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Asheville, North Carolina, 미국, 28801
- Allergy Partners Of West NC
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Chapel Hill, North Carolina, 미국, 27516
- UNC DermatologyandSkinCancer Ctr
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Ohio
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Cincinnati, Ohio, 미국, 45231
- Bernstein Clinical Research Center
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Columbus, Ohio, 미국, 43213
- CR Services Acquisition US
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Fairborn, Ohio, 미국, 45324
- Wright State University
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Toledo, Ohio, 미국, 43617
- Toledo Institute of Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73118
- Unity Clinical Research
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Tulsa, Oklahoma, 미국, 74136
- Vital Prospects Clinical Research Institute
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health Sciences University
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Portland, Oregon, 미국, 97223
- Oregon Medical Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, 미국, 15241
- Allergy and Clinical Immunology Associates
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South Carolina
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Greenville, South Carolina, 미국, 29607
- Allergic Disease and Asthma Center
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Greenville, South Carolina, 미국, 29601
- Tribe Clinical Research LLC
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North Charleston, South Carolina, 미국, 29420
- National Allergy and Asthma Research LLS
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North Charleston, South Carolina, 미국, 29406
- Charleston ENT and Allergy
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Tennessee
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Goodlettsville, Tennessee, 미국, 37072-2301
- Goodlettsville Dermatology Research
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Murfreesboro, Tennessee, 미국, 37130
- International Clinical Research Tennessee LCC
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Texas
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Arlington, Texas, 미국, 76011
- Arlington Center for Dermatology
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Austin, Texas, 미국, 78759
- Orion Clinical Research
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Bellaire, Texas, 미국, 77401
- Bellaire Dermatology Associates
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Dallas, Texas, 미국, 75230
- Reveal Research Institute
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Dallas, Texas, 미국, 75231
- Pharma Research and Amp Consult
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El Paso, Texas, 미국, 79924
- Western Sky Medical Research
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Houston, Texas, 미국, 77030
- Center for Clinical Studies
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Kerrville, Texas, 미국, 78028
- Sante Clinical Research
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San Antonio, Texas, 미국, 78229
- Andante Research
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San Antonio, Texas, 미국, 78213
- RFSA Dermatology
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Utah
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Murray, Utah, 미국, 84107
- University Of Utah
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Sandy City, Utah, 미국, 84093
- Allergy Associates of Utah
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Virginia
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Vienna, Virginia, 미국, 22182
- Forefront Dermatology
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Washington
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Bellingham, Washington, 미국, 98225
- Bellingham Asthma Allergy and Immunology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CLOU064AUS02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .