Myelodysplastic Syndrome Clinical Trial

A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH

Summary

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men and women ≥ 18 years of age.
Historical diagnosis of PNH.
Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab.
Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization.
Lactate dehydrogenase < 1.5 × the upper limit of normal at screening.
Platelet count ≥ 50 × 10^9/L.
Absolute neutrophil count (ANC) > 0.5 x 10^9/L (500/μL).
Participants must be vaccinated against Neisseria meningitidis.
Participants must sign an IRB/IEC-approved ICF before participation in any procedures.

Exclusion Criteria:

Known or suspected hereditary complement deficiency.
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.
Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins).
Known to be positive for human immunodeficiency virus.
Woman who is pregnant or breastfeeding.
Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s).
Participant has known sensitivity to any of the products to be administered during the study, including mammalian cell-derived drug products.
History of meningococcal infection.
Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
History of bone marrow transplantation.
Red blood cell transfusion required within 12 weeks before randomization.
Participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

42

Study ID:

NCT03818607

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 24 Locations for this study

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Children's Healthcare of Atlanta at Egleston
Atlanta Georgia, 30322, United States
Fakultní Nemocnice Brno
Brno Jihormoravsky KRAJ, 625 0, Czechia
Fakultní Nemocnice Olomouc
Olomouc , 772 0, Czechia
Fakultní Nemocnice Ostrava
Ostrava-Poruba , 708 5, Czechia
Keski-Suomen keskussairaala Jyväskylä
Jyväskylä , FI-40, Finland
Päijät-Häme Central Hospital
Lahti , FI-15, Finland
Hôpital Privé Sévigné
Cesson-Sevigne Bretagne, 35576, France
Saint James's Hospital
Dublin , 8, Ireland
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola Forli-cesena, 47014, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza Monza Brianza, 20052, Italy
Azienda Ospedaliera S. Croce e Carle Cuneo
Cuneo , 12100, Italy
Azienda USL della Romagna
Ravenna , 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy
Radboud Universitair Medisch Centrum
Nijmegen Gelderland, 6525 , Netherlands
Oslo University Hospital - Rikshospitalet
Oslo , 0372, Norway
Instituto Português de Oncologia do Porto Francisco Gentil
Porto , 4200-, Portugal
Univerzitetni klinični center Ljubljana
Ljubljana , 1000, Slovenia
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario La Fe
Valencia , 46026, Spain
Karolinska Universitetssjukhuset - Huddinge
Stockholm , 141 8, Sweden
Ege Universitesi Hastanesi - Sağlık Uygulama ve Araştırma Merkezi
Bornova Izmir, 35100, Turkey
Mersin Universitesi Tip Fakultesi
Mersin , 33110, Turkey
The Leeds Teaching Hospitals NHS Trust
Leeds England, LS9 7, United Kingdom
King's College Hospital NHS Foundation Trust
London England, SE5 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

42

Study ID:

NCT03818607

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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