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

A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03818607

Acronym

DAHLIA

Enrollment

Registered

2019-01-28

Start date

2019-01-22

Completion date

2022-07-12

Last updated

2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Keywords

Marchiafava-Micheli Syndrome, Paroxysmal Cold Hemoglobinuria

Brief summary

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

Interventions

DRUGABP 959

intravenous infusion

DRUGEculizumab

intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
LDH Level at Week 27 (Parallel Comparison)	Week 27	The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)	From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79	The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.

Secondary

Measure	Time frame	Description
Mean Serum-free Hemoglobin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Mean Haptoglobin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Mean Bilirubin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Degree of Hemoglobinuria	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	The degree of hemoglobinuria was categorized as negative, trace, small, moderate, and large based on the analysis of urine samples collected from each participant at the specified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Mean Percentage of Type III Erythrocytes	Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79	As a measure of hemolysis the mean percentage of Type III erythrocytes was measured at the specified timepoints. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
LDH Levels at Week 53 and Week 79	Week 53 (first week of Period 2) and Week 79 (last week of Period 2)	The analysis of the crossover comparison of hemolysis, as measured by LDH at Week 53 and Week 79.
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Total complement (%) was measured in serum using an assay method and compared the total hemolytic complement activity to the lower limit of the normal human reference (LLN) of 58 U/mL for all CH50 values. The percent of LLN of CH50 at each time point was calculated as mean CH50 results/LLN x 100%. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Mean Number of Packed RBC Units Transfused Per Month	Baseline to End of Study (up to Week 79)	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)	PK samples were collected predose and immediately postdose Week 13, 7 days post the Week 13 dose (Week 14), and predose at Week 15	The total and unbound PK concentration AUC values from Week 13 to Week 15 in Period 1 are presented by actual treatment received.
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	PK samples were collected predose at the prespecified timepoints: baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77, and Week 79	The total and unbound serum trough concentrations are presented by treatment sequence received for the prespecified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Day 1 to End of Study (up to Week 79)	TEAEs are defined as any adverse event (AE) that began or increased in severity or frequency at or after the time of first treatment up to end of study (up to Week 79). A treatment-emergent serious adverse event (SAE) was a TEAE that met at least 1 of the following criteria: was fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another medically important serious event. The treatment-emergent events of interest (EOI) prespecified for this study included serious infections (meningococcus aspergillus, and other serious infections/sepsis), and infusion reactions.
Number of Participants With Antidrug Antibodies (ADAs)	Blood samples for ADA assessments were taken predose at baseline, Week 3, Week 7, Week 13, Week 19, Week 25, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77 and Week 79.	Any samples that tested positive for binding antibodies were also tested for neutralizing antibodies. Treatment boosted ADAs were defined as a positive immunoassay result at baseline and at least 1 postbaseline immunoassay result that was ≥ 4 times the magnitude of the baseline result. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Mean LDH Levels by Visit up to Week 79	Baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 25, Week 27, Week 29, Week 33, Week 39, Week 41, Week 43, Week 45, Week 47, Week 49, Week 51, Week 53, Week 55, Week 59, Week 65, Week 67, Week 69, Week 71, Week 73, Week 75, Week 77, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.
Mean Total Hemoglobin Levels	Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79	Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Countries

Czechia, Finland, France, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States

Participant flow

Recruitment details

Participants were enrolled at 25 research centers in 14 countries including the Czech Republic, Finland, France, Ireland, Italy, the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Turkey, the United Kingdom, and the United States, and participated from 22 January 2019 to 12 July 2022

Pre-assignment details

42 adult participants with paroxysmal nocturnal hemoglobinuria (PNH) were enrolled and randomized in a 1:1 ratio to receive each investigational product (ABP 959 and eculizumab) in 1 of 2 treatment sequences. Randomization was stratified by red blood cell (RBC) transfusion received within the last 12 months before randomization. There was no washout between Periods 1 and 2.

Participants by arm

Arm	Count
ABP 959/Eculizumab Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.	20
Eculizumab/ABP 959 Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1 followed by ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.	22
Total	42

Withdrawals & dropouts

Period	Reason	FG000	FG001
Period 1 (Week 1 to Week 52)	Adverse Event	0	1
Period 2 (Week 53 to Week 79)	Participant's personal needs	0	1
Period 2 (Week 53 to Week 79)	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	ABP 959/Eculizumab	Eculizumab/ABP 959	Total
Age, Continuous	50.2 years STANDARD_DEVIATION 16.73	50.2 years STANDARD_DEVIATION 16.9	50.2 years STANDARD_DEVIATION 16.61
Mean Number of Packed RBC Units Received in Last 12 Months	1.5 Packed RBC Units STANDARD_DEVIATION 0.71	1.7 Packed RBC Units STANDARD_DEVIATION 1.15	1.6 Packed RBC Units STANDARD_DEVIATION 0.89
Race/Ethnicity, Customized Asian	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Not allowed to collect	4 Participants	4 Participants	8 Participants
Race/Ethnicity, Customized White	16 Participants	17 Participants	33 Participants
RBC Transfusion Within 12 Months Before Randomization per Electronic Case Report Form (eCRF) No	18 Participants	19 Participants	37 Participants
RBC Transfusion Within 12 Months Before Randomization per Electronic Case Report Form (eCRF) Yes	2 Participants	3 Participants	5 Participants
Sex: Female, Male Female	11 Participants	11 Participants	22 Participants
Sex: Female, Male Male	9 Participants	11 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 22	0 / 21	0 / 20
other Total, other adverse events	15 / 20	20 / 22	17 / 21	18 / 20
serious Total, serious adverse events	3 / 20	1 / 22	4 / 21	1 / 20

Outcome results

Primary

LDH Level at Week 27 (Parallel Comparison)

The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).

Time frame: Week 27

Population: The full analysis set (FAS) included all randomized participants.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
ABP 959	LDH Level at Week 27 (Parallel Comparison)	205.69 U/L
Eculizumab	LDH Level at Week 27 (Parallel Comparison)	193.53 U/L

Primary

Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)

The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.

Time frame: From Week 13 to Week 27, from Week 39 to Week 53, and from Week 65 to Week 79

Population: The modified FAS included all randomized participants with an LDH-time profile evaluable for the time-adjusted AUEC, according to treatment assigned during each of the 14-week assessments during Period 1 and 2.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
ABP 959	Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)	1445.76 U*day/L/week
Eculizumab	Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)	1473.44 U*day/L/week

90% CI: [0.9403, 1.0239]

Secondary

Degree of Hemoglobinuria

The degree of hemoglobinuria was categorized as negative, trace, small, moderate, and large based on the analysis of urine samples collected from each participant at the specified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

Population: Participants in the FAS with evaluable urine samples available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
ABP 959	Degree of Hemoglobinuria	Week 53	Large	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 39	Small	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 65	Negative	15 Participants
ABP 959	Degree of Hemoglobinuria	Week 27	Trace	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 65	Trace	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 39	Moderate	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 65	Moderate	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 27	Large	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 65	Large	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 39	Large	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 79	Negative	16 Participants
ABP 959	Degree of Hemoglobinuria	Baseline	Moderate	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 79	Small	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 53	Negative	16 Participants
ABP 959	Degree of Hemoglobinuria	Week 79	Moderate	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 39	Negative	16 Participants
ABP 959	Degree of Hemoglobinuria	Week 79	Large	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 53	Trace	1 Participants
ABP 959	Degree of Hemoglobinuria	Baseline	Trace	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 27	Negative	17 Participants
ABP 959	Degree of Hemoglobinuria	Baseline	Small	2 Participants
ABP 959	Degree of Hemoglobinuria	Week 53	Small	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 27	Small	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 39	Trace	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 27	Moderate	0 Participants
ABP 959	Degree of Hemoglobinuria	Week 53	Moderate	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 65	Small	0 Participants
ABP 959	Degree of Hemoglobinuria	Baseline	Large	1 Participants
ABP 959	Degree of Hemoglobinuria	Week 79	Trace	0 Participants
ABP 959	Degree of Hemoglobinuria	Baseline	Negative	17 Participants
Eculizumab	Degree of Hemoglobinuria	Week 79	Large	0 Participants
Eculizumab	Degree of Hemoglobinuria	Baseline	Negative	21 Participants
Eculizumab	Degree of Hemoglobinuria	Baseline	Small	0 Participants
Eculizumab	Degree of Hemoglobinuria	Baseline	Moderate	0 Participants
Eculizumab	Degree of Hemoglobinuria	Baseline	Large	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 27	Negative	20 Participants
Eculizumab	Degree of Hemoglobinuria	Week 27	Large	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 39	Negative	20 Participants
Eculizumab	Degree of Hemoglobinuria	Week 39	Trace	1 Participants
Eculizumab	Degree of Hemoglobinuria	Week 39	Small	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 39	Moderate	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 39	Large	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 53	Negative	19 Participants
Eculizumab	Degree of Hemoglobinuria	Week 53	Trace	1 Participants
Eculizumab	Degree of Hemoglobinuria	Week 53	Small	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 53	Moderate	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 53	Large	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 65	Negative	17 Participants
Eculizumab	Degree of Hemoglobinuria	Week 65	Small	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 65	Moderate	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 65	Large	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 79	Trace	1 Participants
Eculizumab	Degree of Hemoglobinuria	Week 79	Small	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 79	Moderate	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 27	Moderate	0 Participants
Eculizumab	Degree of Hemoglobinuria	Baseline	Trace	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 27	Trace	1 Participants
Eculizumab	Degree of Hemoglobinuria	Week 27	Small	0 Participants
Eculizumab	Degree of Hemoglobinuria	Week 65	Trace	1 Participants
Eculizumab	Degree of Hemoglobinuria	Week 79	Negative	19 Participants

Secondary

LDH Levels at Week 53 and Week 79

The analysis of the crossover comparison of hemolysis, as measured by LDH at Week 53 and Week 79.

Time frame: Week 53 (first week of Period 2) and Week 79 (last week of Period 2)

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Value (GEOMETRIC_LEAST_SQUARES_MEAN)
ABP 959	LDH Levels at Week 53 and Week 79	209.95 U/L
Eculizumab	LDH Levels at Week 53 and Week 79	203.56 U/L

Secondary

Mean Bilirubin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean Bilirubin Levels	Baseline	23.63 micromol/L	Standard Deviation 12.537
ABP 959	Mean Bilirubin Levels	Week 27	28.69 micromol/L	Standard Deviation 22.529
ABP 959	Mean Bilirubin Levels	Week 39	24.08 micromol/L	Standard Deviation 14.258
ABP 959	Mean Bilirubin Levels	Week 53	25.76 micromol/L	Standard Deviation 17.156
ABP 959	Mean Bilirubin Levels	Week 65	24.51 micromol/L	Standard Deviation 16.736
ABP 959	Mean Bilirubin Levels	Week 79	23.73 micromol/L	Standard Deviation 16.161
Eculizumab	Mean Bilirubin Levels	Week 65	20.02 micromol/L	Standard Deviation 13.808
Eculizumab	Mean Bilirubin Levels	Baseline	21.12 micromol/L	Standard Deviation 13.872
Eculizumab	Mean Bilirubin Levels	Week 53	21.32 micromol/L	Standard Deviation 14.036
Eculizumab	Mean Bilirubin Levels	Week 27	24.30 micromol/L	Standard Deviation 19.209
Eculizumab	Mean Bilirubin Levels	Week 79	23.15 micromol/L	Standard Deviation 17.286
Eculizumab	Mean Bilirubin Levels	Week 39	24.15 micromol/L	Standard Deviation 16.655

Secondary

Mean Haptoglobin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean Haptoglobin Levels	Baseline	0.200 g/L	Standard Deviation 0.2562
ABP 959	Mean Haptoglobin Levels	Week 53	0.196 g/L	Standard Deviation 0.2571
ABP 959	Mean Haptoglobin Levels	Week 27	0.201 g/L	Standard Deviation 0.2809
ABP 959	Mean Haptoglobin Levels	Week 79	0.201 g/L	Standard Deviation 0.2473
ABP 959	Mean Haptoglobin Levels	Week 39	0.196 g/L	Standard Deviation 0.3085
ABP 959	Mean Haptoglobin Levels	Week 65	0.201 g/L	Standard Deviation 0.2521
Eculizumab	Mean Haptoglobin Levels	Week 65	0.466 g/L	Standard Deviation 0.5624
Eculizumab	Mean Haptoglobin Levels	Week 39	0.301 g/L	Standard Deviation 0.4266
Eculizumab	Mean Haptoglobin Levels	Week 53	0.383 g/L	Standard Deviation 0.655
Eculizumab	Mean Haptoglobin Levels	Baseline	0.286 g/L	Standard Deviation 0.3714
Eculizumab	Mean Haptoglobin Levels	Week 79	0.335 g/L	Standard Deviation 0.4744
Eculizumab	Mean Haptoglobin Levels	Week 27	0.300 g/L	Standard Deviation 0.4153

Secondary

Mean LDH Levels by Visit up to Week 79

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 25, Week 27, Week 29, Week 33, Week 39, Week 41, Week 43, Week 45, Week 47, Week 49, Week 51, Week 53, Week 55, Week 59, Week 65, Week 67, Week 69, Week 71, Week 73, Week 75, Week 77, and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 51	229.9 U/L	Standard Deviation 125.47
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 3	210.7 U/L	Standard Deviation 77.8
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 7	201.4 U/L	Standard Deviation 48.41
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 19	188.5 U/L	Standard Deviation 27.58
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 25	230.5 U/L	Standard Deviation 76.07
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 27	191.7 U/L	Standard Deviation 35.99
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 29	207.2 U/L	Standard Deviation 50.35
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 33	194.6 U/L	Standard Deviation 29.36
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 39	188.1 U/L	Standard Deviation 37.55
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 41	196.1 U/L	Standard Deviation 49.21
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 43	215.9 U/L	Standard Deviation 62.41
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 45	202.8 U/L	Standard Deviation 53.15
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 47	199.4 U/L	Standard Deviation 51.72
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 59	209.4 U/L	Standard Deviation 98.42
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 65	230.6 U/L	Standard Deviation 135.26
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 67	196.1 U/L	Standard Deviation 40.61
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 79	229.2 U/L	Standard Deviation 116.85
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 13	207.7 U/L	Standard Deviation 76.14
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 15	213.4 U/L	Standard Deviation 105.86
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 49	216.2 U/L	Standard Deviation 111.26
ABP 959	Mean LDH Levels by Visit up to Week 79	Baseline	199.7 U/L	Standard Deviation 61.06
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 53	224.0 U/L	Standard Deviation 64.49
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 55	213.9 U/L	Standard Deviation 103.58
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 69	200.1 U/L	Standard Deviation 38.12
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 71	196.8 U/L	Standard Deviation 36.36
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 73	210.3 U/L	Standard Deviation 43.9
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 75	207.9 U/L	Standard Deviation 67.51
ABP 959	Mean LDH Levels by Visit up to Week 79	Week 77	209.6 U/L	Standard Deviation 54.35
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 69	186.2 U/L	Standard Deviation 38.48
Eculizumab	Mean LDH Levels by Visit up to Week 79	Baseline	193.9 U/L	Standard Deviation 45.09
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 59	191.4 U/L	Standard Deviation 79.01
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 3	185.8 U/L	Standard Deviation 42.22
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 51	197.7 U/L	Standard Deviation 57.02
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 7	194.0 U/L	Standard Deviation 38.33
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 15	197.0 U/L	Standard Deviation 55.63
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 65	180.9 U/L	Standard Deviation 55.5
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 19	201.0 U/L	Standard Deviation 59.21
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 73	181.9 U/L	Standard Deviation 49.31
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 25	190.2 U/L	Standard Deviation 46.91
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 77	181.4 U/L	Standard Deviation 38.72
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 27	192.2 U/L	Standard Deviation 63.83
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 53	184.7 U/L	Standard Deviation 46.32
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 29	202.1 U/L	Standard Deviation 58.46
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 79	185.8 U/L	Standard Deviation 45.11
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 33	206.8 U/L	Standard Deviation 59.44
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 71	186.6 U/L	Standard Deviation 48.02
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 39	196.9 U/L	Standard Deviation 66.73
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 13	206.2 U/L	Standard Deviation 63.82
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 41	199.7 U/L	Standard Deviation 51
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 67	186.2 U/L	Standard Deviation 50.57
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 43	207.1 U/L	Standard Deviation 79.95
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 75	191.4 U/L	Standard Deviation 65.08
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 45	199.4 U/L	Standard Deviation 66.14
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 49	203.2 U/L	Standard Deviation 68.65
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 47	197.6 U/L	Standard Deviation 65.24
Eculizumab	Mean LDH Levels by Visit up to Week 79	Week 55	188.0 U/L	Standard Deviation 48.91

Secondary

Mean Number of Packed RBC Units Transfused Per Month

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline to End of Study (up to Week 79)

Population: Participants in the FAS who had packed RBC units transfused. The FAS included all randomized participants.

Arm	Measure	Value (MEAN)	Dispersion
ABP 959	Mean Number of Packed RBC Units Transfused Per Month	0.200 packed RBC units per month	Standard Deviation 0.198
Eculizumab	Mean Number of Packed RBC Units Transfused Per Month	0.238 packed RBC units per month	Standard Deviation 0.2078

Secondary

Mean Percentage of Type III Erythrocytes

As a measure of hemolysis the mean percentage of Type III erythrocytes was measured at the specified timepoints. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65 and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean Percentage of Type III Erythrocytes	Week 39	41.2158 Percentage of Type III Erythrocytes	Standard Deviation 24.81071
ABP 959	Mean Percentage of Type III Erythrocytes	Week 53	41.8196 Percentage of Type III Erythrocytes	Standard Deviation 23.23819
ABP 959	Mean Percentage of Type III Erythrocytes	Week 65	39.1192 Percentage of Type III Erythrocytes	Standard Deviation 22.20104
ABP 959	Mean Percentage of Type III Erythrocytes	Week 79	43.7609 Percentage of Type III Erythrocytes	Standard Deviation 21.51712
ABP 959	Mean Percentage of Type III Erythrocytes	Baseline	39.9197 Percentage of Type III Erythrocytes	Standard Deviation 25.36275
ABP 959	Mean Percentage of Type III Erythrocytes	Week 27	40.9121 Percentage of Type III Erythrocytes	Standard Deviation 23.17684
Eculizumab	Mean Percentage of Type III Erythrocytes	Baseline	36.7478 Percentage of Type III Erythrocytes	Standard Deviation 29.9381
Eculizumab	Mean Percentage of Type III Erythrocytes	Week 39	43.3663 Percentage of Type III Erythrocytes	Standard Deviation 29.65777
Eculizumab	Mean Percentage of Type III Erythrocytes	Week 79	42.5501 Percentage of Type III Erythrocytes	Standard Deviation 30.20582
Eculizumab	Mean Percentage of Type III Erythrocytes	Week 53	40.4676 Percentage of Type III Erythrocytes	Standard Deviation 31.1415
Eculizumab	Mean Percentage of Type III Erythrocytes	Week 27	40.1304 Percentage of Type III Erythrocytes	Standard Deviation 30.01551
Eculizumab	Mean Percentage of Type III Erythrocytes	Week 65	37.5379 Percentage of Type III Erythrocytes	Standard Deviation 28.76642

Secondary

Mean Serum-free Hemoglobin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean Serum-free Hemoglobin Levels	Baseline	9.30 mg/dL	Standard Deviation 26.96
ABP 959	Mean Serum-free Hemoglobin Levels	Week 27	5.38 mg/dL	Standard Deviation 14.839
ABP 959	Mean Serum-free Hemoglobin Levels	Week 39	3.74 mg/dL	Standard Deviation 5.093
ABP 959	Mean Serum-free Hemoglobin Levels	Week 53	13.60 mg/dL	Standard Deviation 33.793
ABP 959	Mean Serum-free Hemoglobin Levels	Week 65	3.22 mg/dL	Standard Deviation 2.249
ABP 959	Mean Serum-free Hemoglobin Levels	Week 79	6.59 mg/dL	Standard Deviation 10.232
Eculizumab	Mean Serum-free Hemoglobin Levels	Week 65	2.75 mg/dL	Standard Deviation 2.077
Eculizumab	Mean Serum-free Hemoglobin Levels	Baseline	3.76 mg/dL	Standard Deviation 2.758
Eculizumab	Mean Serum-free Hemoglobin Levels	Week 53	3.08 mg/dL	Standard Deviation 2.529
Eculizumab	Mean Serum-free Hemoglobin Levels	Week 27	3.10 mg/dL	Standard Deviation 2.92
Eculizumab	Mean Serum-free Hemoglobin Levels	Week 79	13.89 mg/dL	Standard Deviation 41.634
Eculizumab	Mean Serum-free Hemoglobin Levels	Week 39	10.25 mg/dL	Standard Deviation 27.926

Secondary

Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])

Total complement (%) was measured in serum using an assay method and compared the total hemolytic complement activity to the lower limit of the normal human reference (LLN) of 58 U/mL for all CH50 values. The percent of LLN of CH50 at each time point was calculated as mean CH50 results/LLN x 100%. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Baseline	6.4 Percent of LLN for all CH50 values	Standard Deviation 13.48
ABP 959	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 27	7.5 Percent of LLN for all CH50 values	Standard Deviation 16.68
ABP 959	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 39	7.4 Percent of LLN for all CH50 values	Standard Deviation 23.8
ABP 959	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 53	12.0 Percent of LLN for all CH50 values	Standard Deviation 34.29
ABP 959	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 65	25.6 Percent of LLN for all CH50 values	Standard Deviation 65.27
ABP 959	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 79	15.8 Percent of LLN for all CH50 values	Standard Deviation 35.65
Eculizumab	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 65	7.8 Percent of LLN for all CH50 values	Standard Deviation 11.37
Eculizumab	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Baseline	2.6 Percent of LLN for all CH50 values	Standard Deviation 4.11
Eculizumab	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 53	4.6 Percent of LLN for all CH50 values	Standard Deviation 6.84
Eculizumab	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 27	6.3 Percent of LLN for all CH50 values	Standard Deviation 12.25
Eculizumab	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 79	6.5 Percent of LLN for all CH50 values	Standard Deviation 12.67
Eculizumab	Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])	Week 39	5.1 Percent of LLN for all CH50 values	Standard Deviation 10.36

Secondary

Mean Total Hemoglobin Levels

Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Baseline, Week 27, Week 39, Week 53, Week 65, and Week 79

Population: Participants in the FAS with data available at each time point. The FAS included all randomized participants.

Arm	Measure	Group	Value (MEAN)	Dispersion
ABP 959	Mean Total Hemoglobin Levels	Week 27	110.6 g/L	Standard Deviation 15.19
ABP 959	Mean Total Hemoglobin Levels	Baseline	113.0 g/L	Standard Deviation 15.03
ABP 959	Mean Total Hemoglobin Levels	Week 65	106.9 g/L	Standard Deviation 17.74
ABP 959	Mean Total Hemoglobin Levels	Week 39	114.6 g/L	Standard Deviation 14.12
ABP 959	Mean Total Hemoglobin Levels	Week 79	113.0 g/L	Standard Deviation 16.78
ABP 959	Mean Total Hemoglobin Levels	Week 53	109.8 g/L	Standard Deviation 15.17
Eculizumab	Mean Total Hemoglobin Levels	Week 79	115.7 g/L	Standard Deviation 16.75
Eculizumab	Mean Total Hemoglobin Levels	Baseline	113.8 g/L	Standard Deviation 16.09
Eculizumab	Mean Total Hemoglobin Levels	Week 27	116.1 g/L	Standard Deviation 16.08
Eculizumab	Mean Total Hemoglobin Levels	Week 39	115.0 g/L	Standard Deviation 15.39
Eculizumab	Mean Total Hemoglobin Levels	Week 53	115.8 g/L	Standard Deviation 15.2
Eculizumab	Mean Total Hemoglobin Levels	Week 65	115.7 g/L	Standard Deviation 18.36

Secondary

Number of Participants With Antidrug Antibodies (ADAs)

Any samples that tested positive for binding antibodies were also tested for neutralizing antibodies. Treatment boosted ADAs were defined as a positive immunoassay result at baseline and at least 1 postbaseline immunoassay result that was ≥ 4 times the magnitude of the baseline result. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: Blood samples for ADA assessments were taken predose at baseline, Week 3, Week 7, Week 13, Week 19, Week 25, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77 and Week 79.

Population: The safety analysis set included all treated participants, with treatment assigned based on actual treatment received.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Neutralizing antibody positive at/before baseline	0 Participants
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Neutralizing antibody positive anytime	0 Participants
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Binding antibody positive postbaseline with negative/no result at baseline	0 Participants
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Treatment boosted antibody positive	0 Participants
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Binding antibody positive at/before baseline	0 Participants
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Overall: Neutralizing antibody positive postbaseline with negative/no result at baseline	0 Participants
ABP 959	Number of Participants With Antidrug Antibodies (ADAs)	Binding antibody positive anytime	0 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Overall: Neutralizing antibody positive postbaseline with negative/no result at baseline	0 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Neutralizing antibody positive anytime	0 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Binding antibody positive at/before baseline	0 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Binding antibody positive postbaseline with negative/no result at baseline	2 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Binding antibody positive anytime	2 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Neutralizing antibody positive at/before baseline	0 Participants
Eculizumab	Number of Participants With Antidrug Antibodies (ADAs)	Treatment boosted antibody positive	0 Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs are defined as any adverse event (AE) that began or increased in severity or frequency at or after the time of first treatment up to end of study (up to Week 79). A treatment-emergent serious adverse event (SAE) was a TEAE that met at least 1 of the following criteria: was fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another medically important serious event. The treatment-emergent events of interest (EOI) prespecified for this study included serious infections (meningococcus aspergillus, and other serious infections/sepsis), and infusion reactions.

Time frame: Day 1 to End of Study (up to Week 79)

Population: The safety analysis set included all treated participants, with treatment assigned based on actual treatment received.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
ABP 959	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	All TEAEs	33 Participants
ABP 959	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any Treatment-emergent EOI: Serious infection	3 Participants
ABP 959	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any Treatment-emergent SAE	7 Participants
ABP 959	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any Treatment-emergent EOI: Infusion reaction	15 Participants
Eculizumab	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any Treatment-emergent EOI: Infusion reaction	15 Participants
Eculizumab	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any Treatment-emergent EOI: Serious infection	0 Participants
Eculizumab	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	All TEAEs	39 Participants
Eculizumab	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any Treatment-emergent SAE	2 Participants

Secondary

Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)

The total and unbound PK concentration AUC values from Week 13 to Week 15 in Period 1 are presented by actual treatment received.

Time frame: PK samples were collected predose and immediately postdose Week 13, 7 days post the Week 13 dose (Week 14), and predose at Week 15

Population: The PK parameter analysis set consisted of a subset of participants from the safety analysis set with an evaluable ABP 959 or eculizumab serum concentration time profile from Week 13 to Week 15.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ABP 959	Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)	Total PK AUC	3898.05 µg*day/mL	Geometric Coefficient of Variation 37.5
ABP 959	Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)	Unbound PK AUC	2761.19 µg*day/mL	Geometric Coefficient of Variation 51.3
Eculizumab	Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)	Total PK AUC	4273.28 µg*day/mL	Geometric Coefficient of Variation 30.6
Eculizumab	Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)	Unbound PK AUC	2903.93 µg*day/mL	Geometric Coefficient of Variation 40.6

Comparison: Total PK AUC GMR (ABP 959/Eculizumab)90% CI: [0.7586, 1.0968]

Comparison: Unbound PK AUC GMR (ABP 959/Eculizumab)90% CI: [0.7454, 1.213]

Secondary

Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab

The total and unbound serum trough concentrations are presented by treatment sequence received for the prespecified time points. Baseline was defined as the last non-missing assessment taken prior to the first dose of IP.

Time frame: PK samples were collected predose at the prespecified timepoints: baseline, Week 3, Week 7, Week 13, Week 15, Week 19, Week 27, Week 33, Week 39, Week 45, Week 51, Week 53, Week 55, Week 59, Week 65, Week 71, Week 77, and Week 79

Population: The PK concentration analysis set consisted of a subset of participants from the safety analysis set with at least one serum concentration (including results below the quantifiable limit) of ABP 959 or eculizumab, with data analyzed according to actual treatment received. Participants with data available at each time point are presented.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 65: Total	190.09 µg/mL	Geometric Coefficient of Variation 62
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 25: Total	217.75 µg/mL	Geometric Coefficient of Variation 50.2
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Baseline: Total	200.15 µg/mL	Geometric Coefficient of Variation 52.8
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 25: Unbound	134.37 µg/mL	Geometric Coefficient of Variation 95.5
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 19: Total	216.46 µg/mL	Geometric Coefficient of Variation 46.3
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 27: Total	198.17 µg/mL	Geometric Coefficient of Variation 58.9
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 3: Total	205.25 µg/mL	Geometric Coefficient of Variation 48.8
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 27: Unbound	112.02 µg/mL	Geometric Coefficient of Variation 111
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 55: Total	210.22 µg/mL	Geometric Coefficient of Variation 59
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 33: Total	211.62 µg/mL	Geometric Coefficient of Variation 55.5
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 3: Unbound	113.99 µg/mL	Geometric Coefficient of Variation 91.5
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 33: Unbound	130.12 µg/mL	Geometric Coefficient of Variation 117.3
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 71: Total	160.43 µg/mL	Geometric Coefficient of Variation 99.5
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 39: Total	183.57 µg/mL	Geometric Coefficient of Variation 68.3
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 7: Total	213.51 µg/mL	Geometric Coefficient of Variation 50.1
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 39: Unbound	131.50 µg/mL	Geometric Coefficient of Variation 104.8
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Baseline: Unbound	94.62 µg/mL	Geometric Coefficient of Variation 100.1
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 45: Total	204.62 µg/mL	Geometric Coefficient of Variation 52.7
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 7: Unbound	116.57 µg/mL	Geometric Coefficient of Variation 92.1
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 45: Unbound	130.30 µg/mL	Geometric Coefficient of Variation 92
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 77: Unbound	140.07 µg/mL	Geometric Coefficient of Variation 98.3
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 51: Total	207.20 µg/mL	Geometric Coefficient of Variation 59.6
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 13: Total	215.54 µg/mL	Geometric Coefficient of Variation 55.8
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 51: Unbound	130.32 µg/mL	Geometric Coefficient of Variation 117.4
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 53: Unbound	108.40 µg/mL	Geometric Coefficient of Variation 130.3
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 53: Total	193.77 µg/mL	Geometric Coefficient of Variation 54.4
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 13: Unbound	114.40 µg/mL	Geometric Coefficient of Variation 98.4
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 55: Unbound	132.20 µg/mL	Geometric Coefficient of Variation 125.4
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 79: Total	178.29 µg/mL	Geometric Coefficient of Variation 60.7
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 59: Total	184.38 µg/mL	Geometric Coefficient of Variation 58.9
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 15: Total	192.80 µg/mL	Geometric Coefficient of Variation 49.1
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 59: Unbound	111.48 µg/mL	Geometric Coefficient of Variation 121.5
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 65: Unbound	110.57 µg/mL	Geometric Coefficient of Variation 146.9
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 71: Unbound	101.66 µg/mL	Geometric Coefficient of Variation 156.7
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 79: Unbound	101.98 µg/mL	Geometric Coefficient of Variation 133.1
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 77: Total	211.80 µg/mL	Geometric Coefficient of Variation 47.2
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 15: Unbound	98.68 µg/mL	Geometric Coefficient of Variation 87
ABP 959	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 19: Unbound	133.39 µg/mL	Geometric Coefficient of Variation 75.2
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 79: Total	199.91 µg/mL	Geometric Coefficient of Variation 50
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 15: Unbound	123.11 µg/mL	Geometric Coefficient of Variation 66.1
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 19: Total	200.51 µg/mL	Geometric Coefficient of Variation 49.1
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 53: Unbound	124.82 µg/mL	Geometric Coefficient of Variation 74.6
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 55: Total	185.34 µg/mL	Geometric Coefficient of Variation 48.4
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 59: Unbound	122.01 µg/mL	Geometric Coefficient of Variation 78.5
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 65: Total	202.83 µg/mL	Geometric Coefficient of Variation 51.5
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 65: Unbound	120.72 µg/mL	Geometric Coefficient of Variation 87.7
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 71: Total	188.05 µg/mL	Geometric Coefficient of Variation 58.6
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 77: Unbound	111.83 µg/mL	Geometric Coefficient of Variation 99.8
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 79: Unbound	116.28 µg/mL	Geometric Coefficient of Variation 96.5
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Baseline: Unbound	117.48 µg/mL	Geometric Coefficient of Variation 71.5
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 3: Total	197.67 µg/mL	Geometric Coefficient of Variation 42.9
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 3: Unbound	116.87 µg/mL	Geometric Coefficient of Variation 68.9
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 7: Total	194.80 µg/mL	Geometric Coefficient of Variation 42.5
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 7: Unbound	98.34 µg/mL	Geometric Coefficient of Variation 108.9
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 13: Total	201.60 µg/mL	Geometric Coefficient of Variation 45.6
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 13: Unbound	123.73 µg/mL	Geometric Coefficient of Variation 69.1
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 15: Total	205.07 µg/mL	Geometric Coefficient of Variation 36.9
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 19: Unbound	120.54 µg/mL	Geometric Coefficient of Variation 77.3
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 25: Total	200.59 µg/mL	Geometric Coefficient of Variation 51.7
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 25: Unbound	112.73 µg/mL	Geometric Coefficient of Variation 96.4
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 27: Total	203.19 µg/mL	Geometric Coefficient of Variation 45.3
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 27: Unbound	122.0 µg/mL	Geometric Coefficient of Variation 83.8
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 33: Total	196.57 µg/mL	Geometric Coefficient of Variation 49.1
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 33: Unbound	126.36 µg/mL	Geometric Coefficient of Variation 78.4
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 39: Total	201.47 µg/mL	Geometric Coefficient of Variation 48.1
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 39: Unbound	129.89 µg/mL	Geometric Coefficient of Variation 75.1
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 45: Total	197.67 µg/mL	Geometric Coefficient of Variation 47.9
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 45: Unbound	126.36 µg/mL	Geometric Coefficient of Variation 77.3
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 51: Total	200.41 µg/mL	Geometric Coefficient of Variation 45.5
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 51: Unbound	123.27 µg/mL	Geometric Coefficient of Variation 68.3
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 53: Total	198.89 µg/mL	Geometric Coefficient of Variation 46.3
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 55: Unbound	117.93 µg/mL	Geometric Coefficient of Variation 77.2
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 59: Total	192.66 µg/mL	Geometric Coefficient of Variation 46.6
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 71: Unbound	104.82 µg/mL	Geometric Coefficient of Variation 115
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Week 77: Total	198.24 µg/mL	Geometric Coefficient of Variation 54.8
Eculizumab	Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab	Baseline: Total	202.58 µg/mL	Geometric Coefficient of Variation 44.3

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Masking description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

LDH Level at Week 27 (Parallel Comparison)

Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)

Degree of Hemoglobinuria

LDH Levels at Week 53 and Week 79

Mean Bilirubin Levels

Mean Haptoglobin Levels

Mean LDH Levels by Visit up to Week 79

Mean Number of Packed RBC Units Transfused Per Month

Mean Percentage of Type III Erythrocytes

Mean Serum-free Hemoglobin Levels

Mean Total Complement (50% Total Hemolytic Complement Activity [CH50])

Mean Total Hemoglobin Levels

Number of Participants With Antidrug Antibodies (ADAs)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Total and Unbound Pharmacokinetics (PK) Area Under the Curve (AUC) of ABP 959 and Eculizumab From Week 13 to Week 15 (Period 1)

Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab