A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
Completed · Phase 3
Conditions studied: Paroxysmal Nocturnal Hemoglobinuria
In brief
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Key facts
- Study ID
- NCT03818607
- Run by
- Amgen
- People needed
- 42
- Starts
- 2019-01-22
- Expected to finish
- 2022-07-12
- Last updated by the study team
- 2023-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
- Fakultní Nemocnice Brno — Brno, Jihormoravsky KRAJ, Czechia
- Fakultní Nemocnice Olomouc — Olomouc, Czechia
- Fakultní Nemocnice Ostrava — Ostrava-Poruba, Czechia
- Keski-Suomen keskussairaala Jyväskylä — Jyväskylä, Finland
- Päijät-Häme Central Hospital — Lahti, Finland
- Hôpital Privé Sévigné — Cesson-Sévigné, Brittany Region, France
- Saint James's Hospital — Dublin, Ireland
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Forli-cesena, Italy
- Azienda Ospedaliera San Gerardo di Monza — Monza, Monza Brianza, Italy
- Azienda Ospedaliera S. Croce e Carle Cuneo — Cuneo, Italy
- Azienda USL della Romagna — Ravenna, Italy
- Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
- Radboud Universitair Medisch Centrum — Nijmegen, Gelderland, Netherlands
- Oslo University Hospital - Rikshospitalet — Oslo, Norway
- Instituto Português de Oncologia do Porto Francisco Gentil — Porto, Portugal
- Univerzitetni klinični center Ljubljana — Ljubljana, Slovenia
- Hospital Universitario de Salamanca — Salamanca, Spain
- Hospital Universitario La Fe — Valencia, Spain
- Karolinska Universitetssjukhuset - Huddinge — Stockholm, Sweden
- Ege Universitesi Hastanesi - Sağlık Uygulama ve Araştırma Merkezi — Bornova, İzmir, Turkey (Türkiye)
- Mersin Universitesi Tip Fakultesi — Mersin, Turkey (Türkiye)
- The Leeds Teaching Hospitals NHS Trust — Leeds, England, United Kingdom
- King's College Hospital NHS Foundation Trust — London, England, United Kingdom
Full record on ClinicalTrials.gov
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