Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH (NCT NCT03818607)

Last Updated: 2023-05-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

Week 27

Results posted on

2023-05-23

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	ABP 959/Eculizumab Participants received ABP 959 900 mg administered intravenously (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.	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.
Period 1 (Week 1 to Week 52) STARTED	20	22
Period 1 (Week 1 to Week 52) Participants Treated	20	22
Period 1 (Week 1 to Week 52) COMPLETED	20	21
Period 1 (Week 1 to Week 52) NOT COMPLETED	0	1
Period 2 (Week 53 to Week 79) STARTED	20	21
Period 2 (Week 53 to Week 79) Participants Treated	20	21
Period 2 (Week 53 to Week 79) COMPLETED	19	20
Period 2 (Week 53 to Week 79) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABP 959/Eculizumab Participants received ABP 959 900 mg administered intravenously (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.	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.
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

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABP 959/Eculizumab n=20 Participants 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.	Eculizumab/ABP 959 n=22 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 16.73 • n=5 Participants	50.2 years STANDARD_DEVIATION 16.90 • n=7 Participants	50.2 years STANDARD_DEVIATION 16.61 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not allowed to collect	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
RBC Transfusion Within 12 Months Before Randomization per Electronic Case Report Form (eCRF) Yes	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
RBC Transfusion Within 12 Months Before Randomization per Electronic Case Report Form (eCRF) No	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Mean Number of Packed RBC Units Received in Last 12 Months	1.5 Packed RBC Units STANDARD_DEVIATION 0.71 • n=5 Participants	1.7 Packed RBC Units STANDARD_DEVIATION 1.15 • n=7 Participants	1.6 Packed RBC Units STANDARD_DEVIATION 0.89 • n=5 Participants

PRIMARY outcome

Timeframe: Week 27

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

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

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
LDH Level at Week 27 (Parallel Comparison)	205.69 U/L Interval 191.23 to 221.24	193.53 U/L Interval 180.8 to 207.17

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ABP 959 n=40 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=40 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)	1445.76 U*day/L/week Interval 1295.63 to 1613.28	1473.44 U*day/L/week Interval 1321.86 to 1642.41

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) Baseline	6.4 Percent of LLN for all CH50 values Standard Deviation 13.48	2.6 Percent of LLN for all CH50 values Standard Deviation 4.11
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) Week 27	7.5 Percent of LLN for all CH50 values Standard Deviation 16.68	6.3 Percent of LLN for all CH50 values Standard Deviation 12.25
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) Week 39	7.4 Percent of LLN for all CH50 values Standard Deviation 23.80	5.1 Percent of LLN for all CH50 values Standard Deviation 10.36
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) Week 53	12.0 Percent of LLN for all CH50 values Standard Deviation 34.29	4.6 Percent of LLN for all CH50 values Standard Deviation 6.84
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) Week 65	25.6 Percent of LLN for all CH50 values Standard Deviation 65.27	7.8 Percent of LLN for all CH50 values Standard Deviation 11.37
Mean Total Complement (50% Total Hemolytic Complement Activity [CH50]) Week 79	15.8 Percent of LLN for all CH50 values Standard Deviation 35.65	6.5 Percent of LLN for all CH50 values Standard Deviation 12.67

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Total Hemoglobin Levels Baseline	113.0 g/L Standard Deviation 15.03	113.8 g/L Standard Deviation 16.09
Mean Total Hemoglobin Levels Week 27	110.6 g/L Standard Deviation 15.19	116.1 g/L Standard Deviation 16.08
Mean Total Hemoglobin Levels Week 39	114.6 g/L Standard Deviation 14.12	115.0 g/L Standard Deviation 15.39
Mean Total Hemoglobin Levels Week 53	109.8 g/L Standard Deviation 15.17	115.8 g/L Standard Deviation 15.20
Mean Total Hemoglobin Levels Week 65	106.9 g/L Standard Deviation 17.74	115.7 g/L Standard Deviation 18.36
Mean Total Hemoglobin Levels Week 79	113.0 g/L Standard Deviation 16.78	115.7 g/L Standard Deviation 16.75

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Serum-free Hemoglobin Levels Baseline	9.30 mg/dL Standard Deviation 26.960	3.76 mg/dL Standard Deviation 2.758
Mean Serum-free Hemoglobin Levels Week 27	5.38 mg/dL Standard Deviation 14.839	3.10 mg/dL Standard Deviation 2.920
Mean Serum-free Hemoglobin Levels Week 39	3.74 mg/dL Standard Deviation 5.093	10.25 mg/dL Standard Deviation 27.926
Mean Serum-free Hemoglobin Levels Week 53	13.60 mg/dL Standard Deviation 33.793	3.08 mg/dL Standard Deviation 2.529
Mean Serum-free Hemoglobin Levels Week 65	3.22 mg/dL Standard Deviation 2.249	2.75 mg/dL Standard Deviation 2.077
Mean Serum-free Hemoglobin Levels Week 79	6.59 mg/dL Standard Deviation 10.232	13.89 mg/dL Standard Deviation 41.634

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Haptoglobin Levels Baseline	0.200 g/L Standard Deviation 0.2562	0.286 g/L Standard Deviation 0.3714
Mean Haptoglobin Levels Week 27	0.201 g/L Standard Deviation 0.2809	0.300 g/L Standard Deviation 0.4153
Mean Haptoglobin Levels Week 39	0.196 g/L Standard Deviation 0.3085	0.301 g/L Standard Deviation 0.4266
Mean Haptoglobin Levels Week 53	0.196 g/L Standard Deviation 0.2571	0.383 g/L Standard Deviation 0.6550
Mean Haptoglobin Levels Week 65	0.201 g/L Standard Deviation 0.2521	0.466 g/L Standard Deviation 0.5624
Mean Haptoglobin Levels Week 79	0.201 g/L Standard Deviation 0.2473	0.335 g/L Standard Deviation 0.4744

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Bilirubin Levels Baseline	23.63 micromol/L Standard Deviation 12.537	21.12 micromol/L Standard Deviation 13.872
Mean Bilirubin Levels Week 27	28.69 micromol/L Standard Deviation 22.529	24.30 micromol/L Standard Deviation 19.209
Mean Bilirubin Levels Week 39	24.08 micromol/L Standard Deviation 14.258	24.15 micromol/L Standard Deviation 16.655
Mean Bilirubin Levels Week 53	25.76 micromol/L Standard Deviation 17.156	21.32 micromol/L Standard Deviation 14.036
Mean Bilirubin Levels Week 65	24.51 micromol/L Standard Deviation 16.736	20.02 micromol/L Standard Deviation 13.808
Mean Bilirubin Levels Week 79	23.73 micromol/L Standard Deviation 16.161	23.15 micromol/L Standard Deviation 17.286

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Degree of Hemoglobinuria Baseline · Negative	17 Participants	21 Participants
Degree of Hemoglobinuria Baseline · Trace	0 Participants	0 Participants
Degree of Hemoglobinuria Baseline · Small	2 Participants	0 Participants
Degree of Hemoglobinuria Baseline · Moderate	0 Participants	0 Participants
Degree of Hemoglobinuria Baseline · Large	1 Participants	0 Participants
Degree of Hemoglobinuria Week 27 · Negative	17 Participants	20 Participants
Degree of Hemoglobinuria Week 27 · Trace	0 Participants	1 Participants
Degree of Hemoglobinuria Week 27 · Small	1 Participants	0 Participants
Degree of Hemoglobinuria Week 27 · Moderate	0 Participants	0 Participants
Degree of Hemoglobinuria Week 27 · Large	1 Participants	0 Participants
Degree of Hemoglobinuria Week 39 · Negative	16 Participants	20 Participants
Degree of Hemoglobinuria Week 39 · Trace	1 Participants	1 Participants
Degree of Hemoglobinuria Week 39 · Small	0 Participants	0 Participants
Degree of Hemoglobinuria Week 39 · Moderate	0 Participants	0 Participants
Degree of Hemoglobinuria Week 39 · Large	0 Participants	0 Participants
Degree of Hemoglobinuria Week 53 · Negative	16 Participants	19 Participants
Degree of Hemoglobinuria Week 53 · Trace	1 Participants	1 Participants
Degree of Hemoglobinuria Week 53 · Small	1 Participants	0 Participants
Degree of Hemoglobinuria Week 53 · Moderate	1 Participants	0 Participants
Degree of Hemoglobinuria Week 53 · Large	0 Participants	0 Participants
Degree of Hemoglobinuria Week 65 · Negative	15 Participants	17 Participants
Degree of Hemoglobinuria Week 65 · Trace	0 Participants	1 Participants
Degree of Hemoglobinuria Week 65 · Small	0 Participants	0 Participants
Degree of Hemoglobinuria Week 65 · Moderate	0 Participants	0 Participants
Degree of Hemoglobinuria Week 65 · Large	1 Participants	0 Participants
Degree of Hemoglobinuria Week 79 · Negative	16 Participants	19 Participants
Degree of Hemoglobinuria Week 79 · Trace	0 Participants	1 Participants
Degree of Hemoglobinuria Week 79 · Small	1 Participants	0 Participants
Degree of Hemoglobinuria Week 79 · Moderate	0 Participants	0 Participants
Degree of Hemoglobinuria Week 79 · Large	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Percentage of Type III Erythrocytes Baseline	39.9197 Percentage of Type III Erythrocytes Standard Deviation 25.36275	36.7478 Percentage of Type III Erythrocytes Standard Deviation 29.93810
Mean Percentage of Type III Erythrocytes Week 27	40.9121 Percentage of Type III Erythrocytes Standard Deviation 23.17684	40.1304 Percentage of Type III Erythrocytes Standard Deviation 30.01551
Mean Percentage of Type III Erythrocytes Week 39	41.2158 Percentage of Type III Erythrocytes Standard Deviation 24.81071	43.3663 Percentage of Type III Erythrocytes Standard Deviation 29.65777
Mean Percentage of Type III Erythrocytes Week 53	41.8196 Percentage of Type III Erythrocytes Standard Deviation 23.23819	40.4676 Percentage of Type III Erythrocytes Standard Deviation 31.14150
Mean Percentage of Type III Erythrocytes Week 65	39.1192 Percentage of Type III Erythrocytes Standard Deviation 22.20104	37.5379 Percentage of Type III Erythrocytes Standard Deviation 28.76642
Mean Percentage of Type III Erythrocytes Week 79	43.7609 Percentage of Type III Erythrocytes Standard Deviation 21.51712	42.5501 Percentage of Type III Erythrocytes Standard Deviation 30.20582

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=39 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=40 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
LDH Levels at Week 53 and Week 79	209.95 U/L Interval 183.817 to 239.802	203.56 U/L Interval 178.387 to 232.295

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean LDH Levels by Visit up to Week 79 Week 79	229.2 U/L Standard Deviation 116.85	185.8 U/L Standard Deviation 45.11
Mean LDH Levels by Visit up to Week 79 Baseline	199.7 U/L Standard Deviation 61.06	193.9 U/L Standard Deviation 45.09
Mean LDH Levels by Visit up to Week 79 Week 3	210.7 U/L Standard Deviation 77.80	185.8 U/L Standard Deviation 42.22
Mean LDH Levels by Visit up to Week 79 Week 7	201.4 U/L Standard Deviation 48.41	194.0 U/L Standard Deviation 38.33
Mean LDH Levels by Visit up to Week 79 Week 13	207.7 U/L Standard Deviation 76.14	206.2 U/L Standard Deviation 63.82
Mean LDH Levels by Visit up to Week 79 Week 15	213.4 U/L Standard Deviation 105.86	197.0 U/L Standard Deviation 55.63
Mean LDH Levels by Visit up to Week 79 Week 19	188.5 U/L Standard Deviation 27.58	201.0 U/L Standard Deviation 59.21
Mean LDH Levels by Visit up to Week 79 Week 25	230.5 U/L Standard Deviation 76.07	190.2 U/L Standard Deviation 46.91
Mean LDH Levels by Visit up to Week 79 Week 27	191.7 U/L Standard Deviation 35.99	192.2 U/L Standard Deviation 63.83
Mean LDH Levels by Visit up to Week 79 Week 29	207.2 U/L Standard Deviation 50.35	202.1 U/L Standard Deviation 58.46
Mean LDH Levels by Visit up to Week 79 Week 33	194.6 U/L Standard Deviation 29.36	206.8 U/L Standard Deviation 59.44
Mean LDH Levels by Visit up to Week 79 Week 39	188.1 U/L Standard Deviation 37.55	196.9 U/L Standard Deviation 66.73
Mean LDH Levels by Visit up to Week 79 Week 41	196.1 U/L Standard Deviation 49.21	199.7 U/L Standard Deviation 51.00
Mean LDH Levels by Visit up to Week 79 Week 43	215.9 U/L Standard Deviation 62.41	207.1 U/L Standard Deviation 79.95
Mean LDH Levels by Visit up to Week 79 Week 45	202.8 U/L Standard Deviation 53.15	199.4 U/L Standard Deviation 66.14
Mean LDH Levels by Visit up to Week 79 Week 47	199.4 U/L Standard Deviation 51.72	197.6 U/L Standard Deviation 65.24
Mean LDH Levels by Visit up to Week 79 Week 49	216.2 U/L Standard Deviation 111.26	203.2 U/L Standard Deviation 68.65
Mean LDH Levels by Visit up to Week 79 Week 51	229.9 U/L Standard Deviation 125.47	197.7 U/L Standard Deviation 57.02
Mean LDH Levels by Visit up to Week 79 Week 53	224.0 U/L Standard Deviation 64.49	184.7 U/L Standard Deviation 46.32
Mean LDH Levels by Visit up to Week 79 Week 55	213.9 U/L Standard Deviation 103.58	188.0 U/L Standard Deviation 48.91
Mean LDH Levels by Visit up to Week 79 Week 59	209.4 U/L Standard Deviation 98.42	191.4 U/L Standard Deviation 79.01
Mean LDH Levels by Visit up to Week 79 Week 65	230.6 U/L Standard Deviation 135.26	180.9 U/L Standard Deviation 55.50
Mean LDH Levels by Visit up to Week 79 Week 67	196.1 U/L Standard Deviation 40.61	186.2 U/L Standard Deviation 50.57
Mean LDH Levels by Visit up to Week 79 Week 69	200.1 U/L Standard Deviation 38.12	186.2 U/L Standard Deviation 38.48
Mean LDH Levels by Visit up to Week 79 Week 71	196.8 U/L Standard Deviation 36.36	186.6 U/L Standard Deviation 48.02
Mean LDH Levels by Visit up to Week 79 Week 73	210.3 U/L Standard Deviation 43.90	181.9 U/L Standard Deviation 49.31
Mean LDH Levels by Visit up to Week 79 Week 75	207.9 U/L Standard Deviation 67.51	191.4 U/L Standard Deviation 65.08
Mean LDH Levels by Visit up to Week 79 Week 77	209.6 U/L Standard Deviation 54.35	181.4 U/L Standard Deviation 38.72

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=2 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=6 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Mean Number of Packed RBC Units Transfused Per Month	0.200 packed RBC units per month Standard Deviation 0.1980	0.238 packed RBC units per month Standard Deviation 0.2078

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	ABP 959 n=18 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=19 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
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	4273.28 µg*day/mL Geometric Coefficient of Variation 30.6
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	2903.93 µg*day/mL Geometric Coefficient of Variation 40.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ABP 959 n=41 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=42 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All TEAEs	33 Participants	39 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Treatment-emergent SAE	7 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Treatment-emergent EOI: Infusion reaction	15 Participants	15 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Treatment-emergent EOI: Serious infection	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Number of Participants With Antidrug Antibodies (ADAs) Binding antibody positive anytime	0 Participants	2 Participants
Number of Participants With Antidrug Antibodies (ADAs) Neutralizing antibody positive anytime	0 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs) Binding antibody positive at/before baseline	0 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs) Neutralizing antibody positive at/before baseline	0 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs) Treatment boosted antibody positive	0 Participants	0 Participants
Number of Participants With Antidrug Antibodies (ADAs) Binding antibody positive postbaseline with negative/no result at baseline	0 Participants	2 Participants
Number of Participants With Antidrug Antibodies (ADAs) Overall: Neutralizing antibody positive postbaseline with negative/no result at baseline	0 Participants	0 Participants

Adverse Events

Period 1: ABP 959

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Period 1: Eculizumab

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Period 2: ABP 959

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Period 2: Eculizumab

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Period 1: ABP 959 n=20 participants at risk Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Period 1: Eculizumab n=22 participants at risk Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Period 2: ABP 959 n=21 participants at risk Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.	Period 2: Eculizumab n=20 participants at risk Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 26 weeks in Period 2.
Blood and lymphatic system disorders Anaemia	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.5% 1/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.8% 1/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	5.0% 1/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 1/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 1/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	5.0% 1/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.8% 1/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	5.0% 1/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.8% 1/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Vertigo CNS origin	5.0% 1/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Depression	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/22 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.8% 1/21 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/20 • Day 1 to End of Study (up to Week 79) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	ABP 959 n=20 Participants Participants received ABP 959 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.	Eculizumab n=22 Participants Participants received eculizumab 900 mg administered IV every 14 ± 2 days for 52 weeks in Period 1.
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 79: Total	178.29 µg/mL Geometric Coefficient of Variation 60.7	199.91 µg/mL Geometric Coefficient of Variation 50.0
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Baseline: Total	200.15 µg/mL Geometric Coefficient of Variation 52.8	202.58 µg/mL Geometric Coefficient of Variation 44.3
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Baseline: Unbound	94.62 µg/mL Geometric Coefficient of Variation 100.1	117.48 µg/mL Geometric Coefficient of Variation 71.5
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 3: Total	205.25 µg/mL Geometric Coefficient of Variation 48.8	197.67 µg/mL Geometric Coefficient of Variation 42.9
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 3: Unbound	113.99 µg/mL Geometric Coefficient of Variation 91.5	116.87 µg/mL Geometric Coefficient of Variation 68.9
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 7: Total	213.51 µg/mL Geometric Coefficient of Variation 50.1	194.80 µg/mL Geometric Coefficient of Variation 42.5
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 7: Unbound	116.57 µg/mL Geometric Coefficient of Variation 92.1	98.34 µg/mL Geometric Coefficient of Variation 108.9
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 13: Total	215.54 µg/mL Geometric Coefficient of Variation 55.8	201.60 µg/mL Geometric Coefficient of Variation 45.6
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 13: Unbound	114.40 µg/mL Geometric Coefficient of Variation 98.4	123.73 µg/mL Geometric Coefficient of Variation 69.1
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 15: Total	192.80 µg/mL Geometric Coefficient of Variation 49.1	205.07 µg/mL Geometric Coefficient of Variation 36.9
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 15: Unbound	98.68 µg/mL Geometric Coefficient of Variation 87.0	123.11 µg/mL Geometric Coefficient of Variation 66.1
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 19: Total	216.46 µg/mL Geometric Coefficient of Variation 46.3	200.51 µg/mL Geometric Coefficient of Variation 49.1
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 19: Unbound	133.39 µg/mL Geometric Coefficient of Variation 75.2	120.54 µg/mL Geometric Coefficient of Variation 77.3
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 25: Total	217.75 µg/mL Geometric Coefficient of Variation 50.2	200.59 µg/mL Geometric Coefficient of Variation 51.7
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 25: Unbound	134.37 µg/mL Geometric Coefficient of Variation 95.5	112.73 µg/mL Geometric Coefficient of Variation 96.4
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 27: Total	198.17 µg/mL Geometric Coefficient of Variation 58.9	203.19 µg/mL Geometric Coefficient of Variation 45.3
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 27: Unbound	112.02 µg/mL Geometric Coefficient of Variation 111.0	122.0 µg/mL Geometric Coefficient of Variation 83.8
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 33: Total	211.62 µg/mL Geometric Coefficient of Variation 55.5	196.57 µg/mL Geometric Coefficient of Variation 49.1
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 33: Unbound	130.12 µg/mL Geometric Coefficient of Variation 117.3	126.36 µg/mL Geometric Coefficient of Variation 78.4
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 39: Total	183.57 µg/mL Geometric Coefficient of Variation 68.3	201.47 µg/mL Geometric Coefficient of Variation 48.1
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 39: Unbound	131.50 µg/mL Geometric Coefficient of Variation 104.8	129.89 µg/mL Geometric Coefficient of Variation 75.1
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 45: Total	204.62 µg/mL Geometric Coefficient of Variation 52.7	197.67 µg/mL Geometric Coefficient of Variation 47.9
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 45: Unbound	130.30 µg/mL Geometric Coefficient of Variation 92.0	126.36 µg/mL Geometric Coefficient of Variation 77.3
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 51: Total	207.20 µg/mL Geometric Coefficient of Variation 59.6	200.41 µg/mL Geometric Coefficient of Variation 45.5
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 51: Unbound	130.32 µg/mL Geometric Coefficient of Variation 117.4	123.27 µg/mL Geometric Coefficient of Variation 68.3
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 53: Total	193.77 µg/mL Geometric Coefficient of Variation 54.4	198.89 µg/mL Geometric Coefficient of Variation 46.3
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 53: Unbound	108.40 µg/mL Geometric Coefficient of Variation 130.3	124.82 µg/mL Geometric Coefficient of Variation 74.6
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 55: Total	210.22 µg/mL Geometric Coefficient of Variation 59.0	185.34 µg/mL Geometric Coefficient of Variation 48.4
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 55: Unbound	132.20 µg/mL Geometric Coefficient of Variation 125.4	117.93 µg/mL Geometric Coefficient of Variation 77.2
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 59: Total	184.38 µg/mL Geometric Coefficient of Variation 58.9	192.66 µg/mL Geometric Coefficient of Variation 46.6
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 59: Unbound	111.48 µg/mL Geometric Coefficient of Variation 121.5	122.01 µg/mL Geometric Coefficient of Variation 78.5
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 65: Total	190.09 µg/mL Geometric Coefficient of Variation 62.0	202.83 µg/mL Geometric Coefficient of Variation 51.5
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 65: Unbound	110.57 µg/mL Geometric Coefficient of Variation 146.9	120.72 µg/mL Geometric Coefficient of Variation 87.7
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 71: Total	160.43 µg/mL Geometric Coefficient of Variation 99.5	188.05 µg/mL Geometric Coefficient of Variation 58.6
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 71: Unbound	101.66 µg/mL Geometric Coefficient of Variation 156.7	104.82 µg/mL Geometric Coefficient of Variation 115.0
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 77: Total	211.80 µg/mL Geometric Coefficient of Variation 47.2	198.24 µg/mL Geometric Coefficient of Variation 54.8
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 77: Unbound	140.07 µg/mL Geometric Coefficient of Variation 98.3	111.83 µg/mL Geometric Coefficient of Variation 99.8
Total and Unbound Trough Serum Concentrations of ABP 959 and Eculizumab Week 79: Unbound	101.98 µg/mL Geometric Coefficient of Variation 133.1	116.28 µg/mL Geometric Coefficient of Variation 96.5