Trial Outcomes & Findings for Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN (NCT NCT04572854)

Last Updated: 2025-03-30

Results Overview

C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Baseline (Day 1) and Week 12

Results posted on

2025-03-30

Participant Flow

This phase 2, open-label study was conducted in subjects with post-transplant recurrence of complement 3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN) at 23 sites across 11 countries. First subject was recruited on 07 September 2021 and data cut-off (DCO) date was 19 January 2024.

The study consisted of 2 parts: Part A core study (controlled and non-controlled portion) and Part B long-term extension. A total of 13 subjects were enrolled in the study. Results are presented based on DCO date of 19 January 2024 for Part A. Subjects who experienced clinical benefit from pegcetacoplan administration could participate in part B, a long-term extension, to continue receiving pegcetacoplan until it is commercially available for the disease under study.

Participant milestones

Participant milestones
Measure	Part A: Controlled Portion: Group 1 Subjects received pegcetacoplan 1080 milligram (mg) twice weekly via subcutaneous (SC) infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 Subjects did not receive any pegcetacoplan treatment until Week 12.	Part A: Non-controlled Portion: Group 1 Subjects who received pegcetacoplan in Part A controlled portion: Group 1 continued to receive pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52 post Week 12 renal biopsy.	Part A: Non-controlled Portion: Group 2 Subjects who did not receive pegcetacoplan in Part A controlled portion: Group 2 received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52 post Week 12 renal biopsy.
Part A: Controlled: Weeks 1 to 12 STARTED	10	3	0	0
Part A: Controlled: Weeks 1 to 12 COMPLETED	10	3	0	0
Part A: Controlled: Weeks 1 to 12 NOT COMPLETED	0	0	0	0
Part A: Non-controlled: Weeks 13 to 52 STARTED	0	0	10	3
Part A: Non-controlled: Weeks 13 to 52 COMPLETED	0	0	8	2
Part A: Non-controlled: Weeks 13 to 52 NOT COMPLETED	0	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Controlled Portion: Group 1 Subjects received pegcetacoplan 1080 milligram (mg) twice weekly via subcutaneous (SC) infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 Subjects did not receive any pegcetacoplan treatment until Week 12.	Part A: Non-controlled Portion: Group 1 Subjects who received pegcetacoplan in Part A controlled portion: Group 1 continued to receive pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52 post Week 12 renal biopsy.	Part A: Non-controlled Portion: Group 2 Subjects who did not receive pegcetacoplan in Part A controlled portion: Group 2 received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52 post Week 12 renal biopsy.
Part A: Non-controlled: Weeks 13 to 52 Adverse Event	0	0	1	1
Part A: Non-controlled: Weeks 13 to 52 Physician Decision	0	0	1	0

Baseline Characteristics

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Controlled Portion: Group 1 n=10 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.	Total n=13 Participants Total of all reporting groups
Age, Continuous	39.8 Years STANDARD_DEVIATION 12.59 • n=93 Participants	44.3 Years STANDARD_DEVIATION 24.03 • n=4 Participants	40.8 Years STANDARD_DEVIATION 14.80 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized White	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	9 Participants n=93 Participants	2 Participants n=4 Participants	11 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The ITT population included all subjects who were randomized.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=10 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12	50.0 Percentage of participants Interval 18.7 to 81.3	33.3 Percentage of participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=10 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52	50.0 Percentage of participants Interval 18.7 to 81.3	66.7 Percentage of participants Interval 9.4 to 99.2

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12 and Week 52

Population: The ITT population included all subjects who were randomized.

C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. Number of subjects who demonstrated a shift of C3c staining from baseline to Week 12 and baseline to Week 52 are presented.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=10 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 3 at baseline to 0 at Week 12	3 Participants	0 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 2 at baseline to 0 at Week 12	1 Participants	0 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 3 at baseline to 1 at Week 12	1 Participants	1 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 2 at baseline to 3 at Week 12	0 Participants	1 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 3 at baseline to 0 at Week 52	4 Participants	1 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 2 at baseline to 0 at Week 52	0 Participants	1 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 3 at baseline to 1 at Week 52	1 Participants	0 Participants
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 Shift from 2 at baseline to 3 at Week 52	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized.

eGFR was calculated by using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation. Stabilization or improvement in eGFR was defined as no more than a 25% decrease relative to baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=10 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52	70.0 Percentage of participants	66.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized.

Stabilization or improvement in serum creatinine was defined as no increase or an increase of no more than 25% from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=10 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52	70.0 Percentage of participants	66.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported.

Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=9 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52	10.1 milliliter/minute/1.73 square meter Standard Deviation 32.67	-10.3 milliliter/minute/1.73 square meter Standard Deviation 14.57

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=9 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52	29.65 percentage change Standard Deviation 78.707	-16.67 percentage change Standard Deviation 21.481

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported.

Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=9 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Change From Baseline in Serum Creatinine Concentration at Week 52	-0.044 milligram per deciliter Standard Deviation 0.8368	0.267 milligram per deciliter Standard Deviation 0.4619

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 52

Population: The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported.

Outcome measures

Outcome measures
Measure	Part A: Controlled Portion: Group 1 n=9 Participants Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 Participants Subjects did not receive any pegcetacoplan treatment until Week 12.
Percentage Change From Baseline in Serum Creatinine Concentration at Week 52	3.198 percentage change Standard Deviation 59.5916	17.778 percentage change Standard Deviation 30.7920

Adverse Events

Part A: Controlled Portion: Group 1

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Part A: Controlled Portion: Group 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: Non-controlled Portion: Group 1

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Part A: Non-controlled Portion: Group 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Controlled Portion: Group 1 n=10 participants at risk Subjects received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 12.	Part A: Controlled Portion: Group 2 n=3 participants at risk Subjects did not receive any pegcetacoplan treatment until Week 12.	Part A: Non-controlled Portion: Group 1 n=10 participants at risk Subjects who received pegcetacoplan in Part A controlled portion: Group 1 continued to receive pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52, post Week 12 renal biopsy.	Part A: Non-controlled Portion: Group 2 n=3 participants at risk Subjects who did not receive pegcetacoplan in Part A controlled portion: Group 2 received pegcetacoplan 1080 mg twice weekly via SC infusion on Day 1 and Day 4 of each treatment week until Week 52, post Week 12 renal biopsy.
Renal and urinary disorders Acute kidney injury	10.0% 1/10 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	20.0% 2/10 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Renal and urinary disorders Nephropathy toxic	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Renal and urinary disorders Renal tubular disorder	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Infections and infestations Arthritis bacterial	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Infections and infestations Genital herpes simplex	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Infections and infestations Pneumocystis jirovecii infection	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Infections and infestations Pneumonia	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Blood and lymphatic system disorders Neutropenia	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Cardiac disorders Cardiac failure	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.
Musculoskeletal and connective tissue disorders Spinal stenosis	10.0% 1/10 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/10 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.	0.00% 0/3 • Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from first dose of study drug for Group 1 subjects or randomization for Group 2 subjects (Day 1) up to 56 days after the last dose of study drug, approximately 139 days for controlled and 333 days for non-controlled portion. All-cause mortality (deaths) were collected from first dose of study drug (Day 1) up to DCO of 19 January 2024, approximately 864 days. The safety population included all subjects who received at least 1 dose of pegcetacoplan and subjects who were randomized into Group 2.

Other adverse events

Additional Information

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