A Randomized, Double-blind, Active-controlled, Phase 3 Study Evaluating theEfficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With ParoxysmalNocturnal Hemoglobinuria (PNH)

OBJECTIVES:Primary Objective: The primary objective for this study is to evaluate the efficacy of ABP 959compared with that of eculizumab based on control of intravascular hemolysis.Secondary Objective: The secondary objective is to assess the safety, pharmacokinetics (PK),and immunogenicity of ABP 959 compared with that of eculizumab.STUDY DESIGN AND METHODOLOGY: This is a randomized, double-blind, active-controlled,2-period crossover study in adult subjects with PNH. Approximately 40 subjects will berandomized (1:1) to receive each investigational product (IP) in 1 of 2 sequences, eithertreatment T followed by treatment R (TR) or treatment R followed by treatment T (RT). Treatmentwill be administered over 2 periods: Period 1 will be 52 weeks in duration Period 2 will start atweek 53 with a crossover in treatment and will be 26 weeks in duration. Randomization will occurwithin 8 days before the first dose of IP administration and will be stratified by red blood cell(RBC) transfusion received within the last 12 months before randomization (yes vs no).Period 1 (week 1 to week 53):Treatment T: ABP 959 at a dose of 900 mg intravenously (IV) every 14 ± 2 days for 52 weeksTreatment R: eculizumab at a dose of 900 mg IV every 14 ± 2 days for 52 weeksPeriod 2: (week 53 to week 79)Treatment T: ABP 959 at a dose of 900 mg IV every 14 ± 2 days for 26 weeksTreatment R: eculizumab at a dose of 900 mg IV every 14 ± 2 days for 26 weeksSubjects may require dose adjustments for IP based on signs and symptoms of intravascularhemolysis, including lactate dehydrogenase (LDH) levels. Upon investigator’s determination ofresolution of symptoms, subjects should resume the 900 mg dose within the recommendeddosing schedule ie, every 14 ± 2 days. If a subject requires extended dose adjustments of IPindicating that the subject is no longer adequately responding to the treatment regimen, thesubject will be discontinued from study.Subjects will remain in the treatment phase until 14 days after the last planned dose of IP inPeriod 2 (ie, at week 79).An independent data monitoring committee (DMC) will evaluate the safety data throughout thestudy.STUDY CENTERS: Approximately 45 sites globally

28.01.2019 – 15.06.2021 BARIŞ TEN, MAHMUT BAKIR KOYUNCU, AYŞEGÜL ÖZ ÖZCAN, NUR AKAD SOYER, İBRAHİM HALİL ACAR

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