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ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab | Clinical Trials | Clareo Health

COMPLETEDPHASE3

ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

NCT03056040•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.

Detailed Description

The study consisted of a 4-week Screening Period and a 26-week Randomized Treatment Period (Primary Evaluation Period). After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive ravulizumab for up to 4 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥18 years of age.
•2. Treated with eculizumab for PNH for at least 6 months prior to Day 1.
•3. Lactate dehydrogenase level ≤1.5 times the upper limit of normal (ULN) at screening.
•4. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
•5. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
•6. 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.
•7. Willing and able to give written informed consent and comply with study visit schedule.

Exclusion Criteria

•1. History of bone marrow transplantation.
•2. Body weight \<40 kilograms at screening.
•3. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
•4. Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleeding, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, or coexisting chronic anemia unrelated to PNH).
•5. Female participants who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or Day 1.
•6. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study treatment on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Locations (51)

Research Site

Duarte, California, United States

Research Site

Los Angeles, California, United States

Research Site

Baltimore, Maryland, United States

Research Site

Detroit, Michigan, United States

Research Site

The Bronx, New York, United States

Research Site

Canberra, Australia

Research Site

Kogarah, Australia

Research Site

Liverpool, Australia

Research Site

Melbourne, Australia

Research Site

Woolloongabba, Australia

Key Dates

Start Date

May 17, 2017

Primary Completion Date

February 21, 2022

Completion Date

February 21, 2022

Last Updated

March 12, 2025

Enrollment

202

ACTUAL participants

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Interventions

Ravulizumab

BIOLOGICAL

Eculizumab

BIOLOGICAL

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

NCT03520647

Severe Aplastic Anemia (SAA)Hypo-Plastic Myelodysplastic Syndrome (MDS)+1 more

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RECRUITINGPHASE1

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment

NCT07152288

Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Inclusion Criteria

Exclusion Criteria

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Subjects With Hepatic Impairment

Hematological Disorders in EHPVO Patients

BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy

Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy

Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)