| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs was defined as AEs that developed or worsened during the on-treatment period. SAE was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs included both Serious TEAEs and non-serious TEAEs. | SAF included all enrolled participants who received any study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Week 104 | | | | ID | Title | Description |
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| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
| | | Title | Denominators | Categories |
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| Participants with TEAEs | | | | Participants with Serious TEAEs | | |
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| Primary | Percentage of Participants Who Achieved Lactate Dehydrogenase (LDH) Less Than or Equal to (≤) 1.5* ULN From Baseline to Week 26 | Percentage of participants who achieved LDH ≤1.5* Upper limit of normal (ULN) over Week 26, defined as LDH ≤1.5*ULN from baseline up to Week 26 were reported. A participant was considered to have met the criteria for adequate control of intravascular hemolysis if all of their LDH readings from the baseline through Week 26 inclusive or through the analysis end date, whichever is earlier, had values ≤ 1.5*ULN. | Full Analysis Set (FAS) included all enrolled participants who received any study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline up to Week 26 | | | | ID | Title | Description |
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| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Percentage of Participants Who Had Breakthrough Hemolysis Through Week 26 and 78 | A participant was considered to have breakthrough hemolysis if he/she had any LDH measurement greater than or equal to (≥) 2*ULN, concomitant with associated signs or symptoms at any time subsequent to an initial achievement of disease control (i.e., LDH ≤ 1.5* ULN). | FAS included all enrolled participants who received any study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Week 26 and 78 | | | | ID | Title | Description |
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| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Overall Rate of Transfusion With Red Blood Cell (RBCs) Through Week 26 | The overall rate of transfusion for a participant was calculated based on the duration of treatment exposure of the participant. | FAS included all enrolled participants who received any study drug. | Posted | | Number | 95% Confidence Interval | Transfusion per person-year of treatment | | Baseline up to Week 26 | | | | ID | Title | Description |
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| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Percentage of Participants Who Are Transfusion-free (With RBCs) Through Week 26 and 78 | Transfusion free was defined as not having received an RBC transfusion during the first 26 and 78 weeks. A transfusion was counted only if it was per-protocol, that is, if it follows the predefined transfusion algorithm: RBC transfusion due to a post-baseline hemoglobin level less than (<) 9 gram per deciliter (g/dL) (with anemia symptoms) or a post-baseline hemoglobin level < 7 g/dL (without anemia symptoms). | FAS included all enrolled participants who received any study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Week 26 and 78 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Percentage of Participants Who Achieved Adequate Control of Intravascular Hemolysis Through Week 78 | A participant was considered to have met the criteria for adequate control of intravascular hemolysis if all of his/her LDH readings from the baseline through Week 78 inclusive or through the analysis end date, whichever is earlier, had values <=1.5* ULN. and must not have discontinued study treatment early. | FAS included all enrolled participants who received any study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline up to Week 78 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Percentage of Participants Who Achieved Normalization of Intravascular Hemolysis Through Week 26 and Week 78 | A participant was considered to have met normalization of intravascular hemolysis if all of their LDH readings from the baseline through Week 26 or 78 inclusive, or through the analysis end date, whichever is earlier, had values ≤ 1.0*ULN. | FAS included all enrolled participants who received any study drug. Here, "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Week 26 and 78 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Changes From Baseline in LDH Levels at Week 26, 78, and 104 | Change from baseline in LDH levels at Week 26, 78, and 104 was reported. Reported baseline is from R3918-PNH-1852 study. | FAS included all enrolled participants who received any study drug. Here, "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Baseline, Week 26, 78, and 104 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Percent Change From Baseline in LDH Levels at Week 26, 78, and 104 | Percent change from baseline in LDH levels at Week 26, 78, and 104 was reported. Reported baseline is from R3918-PNH-1852 study. | FAS included all enrolled participants who received any study drug. Here, "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, Week 26, 78, and 104 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
| |
| Secondary | Change From Baseline in Red Blood Cell (RBC) Hemoglobin Levels at Week 26, 78, and 104 | Change from baseline in RBC hemoglobin levels at Week 26, 78, and 104 was reported. | FAS included all enrolled participants who received any study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Gram per liter (g/l) | | Baseline, Week 26, 78, and 104 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
| |
| Secondary | Change From Baseline in Free Hemoglobin Levels at Week 26, 78 and 104 | Change from baseline in free hemoglobin levels at Week 26, 78 and 104 was reported. | FAS included all enrolled participants who received any study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Milligram per deciliter (mg/dL) | | Baseline, Week 26, 78 and 104 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Serum Concentrations of Total REGN3918 | Serum Concentrations of total REGN3918 was reported. | Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Mean | Standard Deviation | Milligrams per liter (mg/L) | | Pre-dose (Day 1), End of infusion at Week 13, 26, 39, 52, 65, 78, 91 and 104 | | | | ID | Title | Description |
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| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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| Secondary | Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADA) to REGN3918 | Number of Participants with treatment-emergent ADA response to REGN3918 was reported. The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active [SAF]) and had at least 1 non missing anti pozelimab antibody result following the first dose of study drug. The AAS is based on the actual treatment received (as treated). | Here, "number analyzed" signifies those participants who were evaluable at the specified time points. | Posted | | Count of Participants | | Participants | | Baseline up to Week 104 | | | | ID | Title | Description |
|---|
| OG000 | REGN3918 | Participants who completed parent study R3918-PNH-1852 (NCT03946748) received pozelimab 800 mg SC injection QW for up to 104 weeks. |
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