| Primary | Number of Patients Achieving a Response (R) at Week 24 | A participant was considered to have a response if the Hgb level increased greater than or equal to (>=) 1.5 gram per deciliter (g/dL) from baseline and this increase was maintained from Week 16 through Week 24 in absence of blood transfusion from Week 5 through Week 24. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Change From Baseline to Week 24 in Hemoglobin (Hgb) Level-Part A in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange) Mean change from Baseline to Week 24 in Hemoglobin (Hgb) level.
| | Posted | | Least Squares Mean | Standard Error | grams per deciliter (g/dL) | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Number of Patients Achieving Transfusion Avoidance From Week 5 to Week 24-Part A | Percentage of patients who did not receive a blood transfusion between Week 5 and Week 24 was assessed | Number of Patients Achieving Transfusion Avoidance at Week 24 | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in FACT-An Scale Score (Quality of Life)-Part A in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
FACT-An is used to measure quality of life (QoL) in patients with anemia. Each item is rated on a 5-point Likert scale:0=Not at all, 1=A little bit ,2=Somewhat, 3=Quite a bit, 4=Very much. Some items are reverse scored. Higher scores in this scale denote a better QoL with less impact of anemia.The total FACT-An scale score ranges from 0 to 160. The total score gives a comprehensive view of a patient's well-being. It combines the FACT-G with an Anemia subscale. FACT-G (27 items):Physical Well-Being (PWB) and Social/Family Well-Being (SWB) 14 items in total, Emotional Well-Being (EWB)-6 items,Functional Well-Being (FWB)-7 items, Anemia Subscale (AnS): 13 items. Total FACT-An score=FACT-G + Anemia Subscale=40 item | | Posted | | Mean | Standard Deviation | Units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
|
| Secondary | Number of Packed Red Blood Cell Transfusions Received by Patients From Week 5 to Week 24-Part A | Number of blood transfusions received between Week 5 and Week 24 were assessed. | | Posted | | Mean | Standard Deviation | Number of transfusions | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in LDH Levels-Part A in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange) Mean change from baseline to Week 24 in Lactate dehydrogenase (LDH) levels
| | Posted | | Mean | Standard Deviation | U/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in Haptoglobin Levels-Part A in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from baseline to Week 24 in Haptoglobin level | | Posted | | Mean | Standard Deviation | g/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in Indirect Bilirubin-Part A in the Absence of Intercurrent Events (ICE) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from baseline to Week 24 in Indirect bilirubin level | | Posted | | Mean | Standard Deviation | µmol/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in ARC-Part A in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from baseline to Week 24 in Absolute reticulocyte counts (ARC). | | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in D-dimer Levels-Part A in the Absence of Intercurrent Events (ICEs |
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange) change from baseline to Week 24 in D-dimer levels.
| | Posted | | Mean | Standard Deviation | µg/L FEU | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Normalization of Markers of Hemolysis (LDH) at Week 24-Part A | Percentage of patients with LDH level within normal ranges and with an abnormal value at baseline. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Normalization of Markers of Hemolysis (Indirect Bilirubin) at Week 24-Part A | Percentage of patients with Indirect Bilirubin level within normal ranges and with an abnormal value at baseline. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Normalization of Markers of Hemolysis (ARC) at Week 24-Part A | Percentage of patients with ARC level within normal ranges and with an abnormal value at baseline. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Normalization of Markers of Hemolysis (Haptoglobin) at Week 24-Part A | Percentage of patients with haptoglobin level within normal ranges and with an abnormal value at baseline. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Haptoglobin Levels-Part A | Percentage of patients with haptoglobin level normalization during the initial 24 weeks of the study | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Hemoglobin Levels-Part A | Percentage of patients with Hemoglobin level normalization during the initial 24 weeks of the study | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for LDH Levels-Part A | Percentage of patients with LDH level normalization during the initial 24 weeks of the study | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for Indirect Bilirubin Levels-Part A | Percentage of patients with Indirect Bilirubin level normalization during the initial 24 weeks of the study | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Count and Percentage of Patients With a First Normalization From Baseline by Week 24 for ARC Levels-Part A | Percentage of patients with ARC level normalization during the initial 24 weeks of the study | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Number of Packed Red Blood Cell Units Transfused From Week 5 to Week 24-Part A | Number of PRBC units transfused from Week 5 and Week 24 was assessed | | Posted | | Mean | Standard Deviation | Number of PRBC units transfused | | Week 5 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in FACIT-F Subscale Score-Part A in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
The FACIT-F subscale is used to measure fatigue and its impact upon daily activities and function in patients with chronic illnesses and contains 20 items related to the impact of fatigue. Each item is scored on a 0-4 scale, with some items reverse-scored. Total scores range from 0 to 52, where higher scores indicate less fatigue and better outcomes, and lower scores reflect greater fatigue. It can be used alone or with other FACIT subscales as part of broader quality of life assessments. | | Posted | | Mean | Standard Deviation | Units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in SF-12-Part A in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange.
SF-12 is a 12-item health survey assessing physical and mental health. Higher scores mean better health with scores above 50 indicating better than average health. It produces two summary scores: the Physical Component Summary (PCS) and Mental Component Summary (MCS), both norm-based (mean=50, SD=10), with ranges of ~5-80 (PCS) and ~-3.3-80 (MCS). Higher scores=better health. It also covers 8 subscales-Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH), each scored between 0-100, where higher=better functioning. Scores are computed using weighted formulas from item responses (not simple averages). | | Posted | | Mean | Standard Deviation | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 24 in EQ-5D-5L Questionnaire -Part A in the Absence of Intercurrent Events (ICEs) | The EQ-5D-5L measures total health across 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression-each scored from 1 (no problems) to 5 (extreme problems). Scores form a 5-digit health profile (e.g., 12345). Each individual score plus a VAS for perceived health status today are separately reported. Higher scores reflect better total health. The EQ VAS is a patient-rated score from 0 (worst) to 100 (best health). The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
| | Posted | | Mean | Standard Deviation | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Pegcetacoplan Double Blind During Part A | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Placebo Matching Pegcetacoplan-Double-blind During Part A | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in Hemoglobin (Hgb) Level-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from Baseline to Week 48 in Hemoglobin (Hgb) level. | | Posted | | Mean | Standard Deviation | grams per deciliter (g/dL) | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in LDH Level-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from Baseline to Week 48 in LDH level. | | Posted | | Mean | Standard Deviation | U/L | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in Haptoglobin Level-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from Baseline to Week 48 in Haptoglobin level | | Posted | | Mean | Standard Deviation | grams per deciliter (g/dL) | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in Indirect Bilirubin Level-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from Baseline to Week 48 in Indirect Bilirubin level. | | Posted | | Mean | Standard Deviation | µmol/L | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in ARC-Part B in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from baseline to Week 48 in Absolute reticulocyte counts (ARC). | | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in D-dimer Levels-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
Mean change from baseline to Week 48 in D-dimer levels. | | Posted | | Mean | Standard Deviation | µg/L FEU | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in FACT-An Scale Score (Quality of Life)-Part B in the Absence of Intercurrent Events (ICEs) | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug and plasma exchange.
The FACT-An is used to measure quality of life (QoL) in patients with anemia. Each item is rated on a 5-point Likert scale:0=Not at all, 1=A little bit ,2=Somewhat, 3=Quite a bit, 4=Very much.Some items are reverse scored. Higher scores in this scale denote a better QoL with less impact of anemia. The total FACT-An scale score ranges from 0 to 160. The total score gives a comprehensive view of a patient's well-being. It combines the FACT-G with an Anemia subscale.FACT-G (27 items):Physical Well-Being (PWB) and Social/Family Well-Being (SWB) 14 items in total, Emotional Well-Being (EWB)-6 items, Functional Well-Being (FWB)-7 items, Anemia Subscale (AnS): 13 items. Total FACT-An score=FACT-G + Anemia Subscale=40 items | | Posted | | Mean | Standard Deviation | Units on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
|
| Secondary | Change From Baseline to Week 48 in FACIT-F Subscale Score-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
The FACIT-F subscale is used to measure fatigue and its impact upon daily activities and function in patients with chronic illnesses and contains 20 items related to the impact of fatigue. Each item is scored on a 0-4 scale, with some items reverse-scored. Total scores range from 0 to 52, where higher scores indicate less fatigue and better outcomes, and lower scores reflect greater fatigue. It can be used alone or with other FACIT subscales as part of broader quality of life assessments. | | Posted | | Mean | Standard Deviation | Units on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in EQ-5D-5L-Part B in the Absence of Intercurrent Events (ICEs). | The EQ-5D-5L measures total health across 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression-each scored from 1 (no problems) to 5 (extreme problems). Scores form a 5-digit health profile (e.g., 12345). Each individual score plus a VAS for perceived health status today are separately reported. Higher scores reflect better total health. The EQ VAS is a patient-rated score from 0 (worst) to 100 (best health). The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange).
| | Posted | | Mean | Standard Deviation | Units on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |
| Secondary | Change From Baseline to Week 48 in SF-12-Part B in the Absence of Intercurrent Events (ICEs). | The ICEs of interest were :
- Withdrawal from treatment or lost to follow-up before the end of the double-blind period
- Use of prohibited medications (rituximab alone or in combination, any other complement inhibitor, any other investigational drug, and plasma exchange SF-12 is a 12-item health survey assessing physical and mental health. Higher scores mean better health with scores above 50 indicating better than average health. It produces two summary scores: the Physical Component Summary (PCS) and Mental Component Summary (MCS), both norm-based (mean = 50, SD =10), with ranges of ~5-80 (PCS) and ~-3.3-80 (MCS). Higher scores = better health. It also covers 8 subscales-Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH), each scored between 0-100, where higher=better functioning. Scores are computed using weighted formulas from item responses (not simple averages).
| | Posted | | Mean | Standard Deviation | units on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Open-label Pegcetacoplan During Part B | 1080 mg, subcutaneous injection, twice weekly | | OG001 | Open-label Pegcetacoplan (Placebo Matching Pegcetacoplan During Part A) During Part B | Placebo matching pegcetacoplan taken twice weekly as subcutaneous injection |
| |