Myelodysplastic Syndrome Clinical Trial

Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Summary

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.

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Full Description

The study will consist of an up to 30 day Screening Period, a 10-week Randomized Treatment Period, and a 172-week Extension Period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

136

Study ID:

NCT03748823

Recruitment Status:

Active, not recruiting

Sponsor:

Alexion Pharmaceuticals

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There is 1 Location for this study

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Clinical Trial Site
Los Angeles California, 90033, United States
Clinical Trial Site
Liverpool , , Australia
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Parkville , , Australia
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Vienna , , Austria
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Antwerpen , , Belgium
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Brussels , , Belgium
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Hasselt , , Belgium
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Leuven , , Belgium
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Botucatu , , Brazil
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Ribeirão Preto , , Brazil
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Rio De Janeiro , , Brazil
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Salvador , , Brazil
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São Paulo , , Brazil
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Toronto , , Canada
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Helsinki , , Finland
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Amiens , , France
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Brest , , France
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Lille , , France
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Montpellier , , France
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Nantes , , France
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Nice , , France
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Paris , , France
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Pessac , , France
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Pierre-Bénite , , France
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Poitiers , , France
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Rennes , , France
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Strasbourg , , France
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Tours , , France
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Catania , , Italy
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Milano , , Italy
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Roma , , Italy
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Maastricht , , Netherlands
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Ekaterinburg , , Russian Federation
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Moscow , , Russian Federation
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Saint Petersburg , , Russian Federation
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Barcelona , , Spain
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Donostia , , Spain
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Las Palmas De Gran Canaria , , Spain
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Madrid , , Spain
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Majadahonda , , Spain
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Sevilla , , Spain
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Uppsala , , Sweden
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Adana , , Turkey
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Istanbul , , Turkey
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İzmir , , Turkey

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

136

Study ID:

NCT03748823

Recruitment Status:

Active, not recruiting

Sponsor:


Alexion Pharmaceuticals

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