Myelodysplastic Syndrome Clinical Trial
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 6 months.
The study will consist of an up to 30 day Screening Period, a 10-week Randomized Treatment Period, and a 172-week Extension Period.
Male or female ≥18 years of age
Treated with eculizumab for PNH for at least 3 months prior to Day 1
LDH level ≤1.5 × upper limit of normal (ULN) at screening
PNH diagnosis confirmed by documented high-sensitivity flow cytometry.
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
Body weight ≥40 to <100 kilogram (kg)
Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
Willing and able to give written informed consent and comply with study visit schedule.
LDH level ≤ 2 × upper limit of normal (ULN) within 3 months prior to Day 1
History of bone marrow transplantation.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the Investigator or Sponsor, would preclude participation.
Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH).
Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1.
Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
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There is 1 Location for this study
Los Angeles California, 90033, United States
Liverpool , , Australia
Parkville , , Australia
Vienna , , Austria
Antwerpen , , Belgium
Brussels , , Belgium
Hasselt , , Belgium
Leuven , , Belgium
Botucatu , , Brazil
Ribeirão Preto , , Brazil
Rio De Janeiro , , Brazil
Salvador , , Brazil
São Paulo , , Brazil
Toronto , , Canada
Helsinki , , Finland
Amiens , , France
Brest , , France
Lille , , France
Montpellier , , France
Nantes , , France
Nice , , France
Paris , , France
Pessac , , France
Pierre-Bénite , , France
Poitiers , , France
Rennes , , France
Strasbourg , , France
Tours , , France
Catania , , Italy
Milano , , Italy
Roma , , Italy
Maastricht , , Netherlands
Ekaterinburg , , Russian Federation
Moscow , , Russian Federation
Saint Petersburg , , Russian Federation
Barcelona , , Spain
Donostia , , Spain
Las Palmas De Gran Canaria , , Spain
Madrid , , Spain
Majadahonda , , Spain
Sevilla , , Spain
Uppsala , , Sweden
Adana , , Turkey
Istanbul , , Turkey
İzmir , , Turkey
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