Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Study Identifier:
ALXN1210-PNH-303
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Paroxysmal Nocturnal Hemoglobinuria
Study Drug
- Biological: Ravulizumab
Date
Feb 2019 - Feb 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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
- More than 1 LDH value \> 2 × ULN within the 3 months prior to study entry
- 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.
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Paroxysmal Nocturnal Hemoglobinuria
Study Drug
- Biological: Ravulizumab
Date
Feb 2019 - Feb 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion 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
- More than 1 LDH value \> 2 × ULN within the 3 months prior to study entry
- 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.
Protocol 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 3 months prior to study entry.
Trial Locations
Location
Status
Location
Research Site
Los Angeles, California, United States, 90089
Status
N/A
Location
Research Site
Liverpool, Australia, 2170
Status
N/A
Location
Research Site
Parkville, Australia, 3050
Status
N/A
Location
Research Site
Vienna, Austria, 1090
Status
N/A
Location
Research Site
Antwerp, Belgium, 2020
Status
N/A
Location
Research Site
Brussels, Belgium, 1200
Status
N/A
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