Myelodysplastic Syndrome Clinical Trial
A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Summary
A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 250 participants.
Eligibility Criteria
Inclusion Criteria:
Body weight >= 40 kg at screening.
Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.
Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.
Willingness and ability to comply with all study visits and procedures.
Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration.
Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label).
Exclusion Criteria:
History of allogeneic bone marrow transplantation.
History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high.
Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label).
Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment.
Positive for Active Hepatitis B and C infection (HBV/HCV).
Concurrent disease, treatment, procedure, or surgery or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study.
History of or ongoing cryoglobulinemia at screening.
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There are 116 Locations for this study
Anaheim California, 92801, United States
Los Angeles California, 90095, United States
Indianapolis Indiana, 46237, United States
Detroit Michigan, 48202, United States
Charlotte North Carolina, 28208, United States
Columbus Ohio, 43205, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78229, United States
Liverpool New South Wales, 2170, Australia
Westmead New South Wales, 2145, Australia
Perth Western Australia, 6000, Australia
Bruxelles , 1200, Belgium
Roeselare , 8800, Belgium
Yvoir , B5530, Belgium
Fortaleza CE, 60430, Brazil
Brasilia DF, 70684, Brazil
Taguatinga DF, 72145, Brazil
Maringa PA, 87015, Brazil
Curitiba PR, 80810, Brazil
Canoas RS, 92010, Brazil
Porto Alegre RS, 90020, Brazil
Porto Alegre RS, , Brazil
Joinville SC, 89201, Brazil
JAU SP, 17210, Brazil
Ribeirao Preto SP, 14048, Brazil
Santo André SP, 09060, Brazil
Sao Paulo SP, 01308, Brazil
Sao Paulo SP, 01321, Brazil
São Paulo SP, 01321, Brazil
Levis Quebec, G6V 3, Canada
Bogota , 11011, Colombia
Praha , 128 0, Czechia
Tallinn , 13419, Estonia
Lille , 59037, France
Marseille , 13273, France
Rennes cedex 9 , 35033, France
Aachen , 52074, Germany
Essen , 45147, Germany
Riesa , 01589, Germany
Ulm , 89081, Germany
Alexandroupolis , 681 0, Greece
Athens , 115 2, Greece
Chaidari , 124 6, Greece
Larissa , 412 2, Greece
Thessaloniki , 57010, Greece
Shatin , 12345, Hong Kong
Budapest , 1088, Hungary
Dublin , 8, Ireland
Avellino Campania, 83100, Italy
Ravenna Emilia-Romagna, 48100, Italy
Roma Lazio, 00168, Italy
Milano Molise, 20122, Italy
Torino Piemonte, 10126, Italy
Catania Sicilia, 95123, Italy
Florence Toscana, 50134, Italy
Aichi , 470-1, Japan
Fukushima , 960-1, Japan
Hokkaido , 060-8, Japan
Hyogo , 650-0, Japan
Hyogo , 676-0, Japan
Ibaraki , 305-8, Japan
Ishikawa , 920-8, Japan
Kanagawa , 259-1, Japan
Mie , 514-8, Japan
Nagano , 392-8, Japan
Nagasaki , 852-8, Japan
Nagasaki , 857-8, Japan
Okayama , 701-1, Japan
Osaka , 565-0, Japan
Oshu , 023-0, Japan
Tokyo , 141-8, Japan
Tokyo , 160-0, Japan
Toyama , 930-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Amsterdam , 1105 , Netherlands
Bydgoszcz , 85-16, Poland
Gdansk , 80-95, Poland
Krakow , 31-50, Poland
Lublin , 20-08, Poland
Skórzewo , 60-18, Poland
Warszawa , 02-17, Poland
Porto , 4099-, Portugal
Riyadh , 12713, Saudi Arabia
Singapore , 11759, Singapore
Badalona Barcelona, 08916, Spain
Esplugues De Llobregas Barcelona, 08950, Spain
Santiago de Compostela LA Coruña, 5ºA, Spain
Las Palmas de Gran Canaria LAS Palmas, 35019, Spain
Bilbao Vizcaya, 48013, Spain
Asturias , 33011, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Caceres , 10003, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Toledo , 45004, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Uppsala , 751 8, Sweden
Chang Hua , 500, Taiwan
Hualien City , 97002, Taiwan
Liuying Township , 736, Taiwan
Taipei , 100, Taiwan
Zhongshan Dist. , 10449, Taiwan
Ankara , 06100, Turkey
Gaziantep , 27310, Turkey
Istanbul , 34093, Turkey
Istanbul , 34300, Turkey
Izmir , 35040, Turkey
Samsun , 55139, Turkey
London , SE5 9, United Kingdom
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