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

• Status: Active, not recruiting
• Trial end date: 2022-07-13
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Eculizumab

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.