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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03500549
Registration number
NCT03500549
Ethics application status
Date submitted
10/04/2018
Date registered
18/04/2018
Date last updated
25/03/2022
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
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Scientific title
A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
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Secondary ID [1]
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APL2-302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paroxysmal Nocturnal Hemoglobinuria
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Condition category
Condition code
Blood
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0
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Haematological diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pegcetacoplan
Treatment: Drugs - Soliris
Experimental: Pegcetacoplan - 1080 mg pegcetacoplan administered subcutaneously twice-weekly or every three days.
Active Comparator: Eculizumab - Complement (C5) Inhibitor.
Treatment: Drugs: Pegcetacoplan
Complement (C3) Inhibitor
Treatment: Drugs: Soliris
Complement (C5) Inhibitor
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Least Squares (LS) Mean Change From Baseline to Week 16 in Hemoglobin (Hb) Level During the RCP
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Assessment method [1]
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Baseline was the average of measurements recorded before taking the first dose of pegcetacoplan, which included local and central laboratory values during the screening period. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [1]
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Percentage of Subjects Who Did Not Require a Transfusion (Transfusion Avoidance) During the RCP
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Assessment method [1]
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Subjects who experienced more than 1 transfusion during the RCP are only counted once. Subjects who did not have a transfusion but withdrew before Week 16 were considered as having a transfusion in the analysis of transfusion avoidance.
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Timepoint [1]
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Day 1 to Week 16
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Secondary outcome [2]
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LS Mean Change From Baseline to Week 16 in Absolute Reticulocyte Count (ARC) During the RCP
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Assessment method [2]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [3]
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LS Mean Change From Baseline to Week 16 in Lactate Dehydrogenase (LDH) Level During the RCP
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Assessment method [3]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [3]
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Baseline and Week 16
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Secondary outcome [4]
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LS Mean Change From Baseline to Week 16 in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Score During the RCP
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Assessment method [4]
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The FACIT-fatigue scale version 4 is a 13-item Likert scaled instrument where the subject was presented with 13 statements and asked to indicate their response as it applied to the past 7 days. The 5 possible responses were 'Not at all' (0), 'A little bit (1), 'Somewhat' (2), 'Quite a bit' (3) and 'Very much' (4). With 13 statements the total score had a range of 0 to 52. A higher score corresponds to a higher quality of life (QoL). Baseline was the last available, nonmissing observation before taking the first dose of pegcetacoplan. Data collected after transfusion is excluded from analysis.
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Timepoint [4]
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Baseline and Week 16
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Secondary outcome [5]
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Percentage of Subjects Who Achieved a Hb Response in the Absence of Transfusions at Week 16
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Assessment method [5]
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Hb response was defined as an increase of at least 1 g/dL in Hb from Baseline at Week 16. Baseline was the average of measurements recorded before taking the first dose of pegcetacoplan, which included local and central laboratory values during the screening period. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [5]
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Baseline and Week 16
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Secondary outcome [6]
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Percentage of Subjects Who Achieved Reticulocyte Normalization in the Absence of Transfusions at Week 16
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Assessment method [6]
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Reticulocyte normalization was defined as the ARC being below the upper limit of the gender-specific normal range at Week 16, censored for transfusions. Subjects who received a transfusion between Day 1 and Week 16 or withdrew without providing efficacy data at Week 16 were classified as nonresponders.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Percentage of Subjects Who Achieved Hb Normalization in the Absence of Transfusions at Week 16
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Assessment method [7]
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Hb normalization was defined as the Hb level being above the lower limit of the normal range at Week 16, censored for transfusions. Subjects who received a transfusion between Day 1 and Week 16 or withdrew without providing efficacy data at Week 16 are classified as nonnormalization.
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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LS Mean Change From Baseline to Week 16 in Indirect Bilirubin Level During the RCP
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Assessment method [8]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [8]
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Baseline and Week 16
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Secondary outcome [9]
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LS Mean Change From Baseline to Week 16 in Haptoglobin Level During the RCP
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Assessment method [9]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [9]
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Baseline and Week 16
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Secondary outcome [10]
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LS Mean Change From Baseline to Week 16 in Linear Analog Scale Assessment (LASA) Scores During the RCP
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Assessment method [10]
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The LASA consists of 3 items, where the respondents were asked to rate their perceived level of functioning. Specific domains included activity level, ability to carry out daily activities, and an item for overall QoL. Their level of functioning was reported on a 0 to 100 scale with 0 indicates "As low as could be" and 100 indicates "As high as could be". The combined score ranged from 0 to 300, with higher scores corresponding to a higher QoL.
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Timepoint [10]
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Baseline and Week 16
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Secondary outcome [11]
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LS Mean Change From Baseline to Week 16 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Scale (QLQ-C30) Scores During the RCP
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Assessment method [11]
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The EORTC QLQ-C30 questionnaire (version 3.0) consists of 30 questions comprised of both multi-item scales and single-item measures to assess overall QoL in subjects. Questions are designated by functional scales, symptom scales, and global subject QoL/overall perceived health status. For the first 28 questions the 4 possible responses are "Not at all' (1), 'A little' (2), 'Quite a bit' (3) and 'Very much' (4). For the remaining 2 questions the response is requested on a 7-point scale from 1 ('Very poor') to 7 ('Excellent'). The raw scale scores were linear transformed, producing scale scores that ranged from 0% to 100%. A high scale score represents a higher response level. Hence for the functional scales and the global health status a higher score indicates a better QoL, whilst for the symptom scale scores this is implied by a lower score.
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Timepoint [11]
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Baseline and Week 16
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Secondary outcome [12]
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Total Number of PRBC Units Transfused During the RCP
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Assessment method [12]
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Subjects who withdrew during the RCP before Week 16 will have their number of units of PRBC estimated from the duration they were in the study.
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Timepoint [12]
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Day 1 to Week 16
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Secondary outcome [13]
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Mean Change From Baseline to Week 48 in Hb Level During the Treatment Period
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Assessment method [13]
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Baseline was the average of measurements recorded before taking the first dose of pegcetacoplan, which included local and central laboratory values during the screening period. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [13]
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Baseline and Week 48
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Secondary outcome [14]
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Mean Change From Week 17 to Week 48 in Hb Level During the Open-label Period
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Assessment method [14]
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Baseline was the average of measurements recorded before taking the first dose of pegcetacoplan, which included local and central laboratory values during the screening period. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [14]
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Week 17 and Week 48
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Secondary outcome [15]
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Mean Change From Baseline to Week 48 in ARC During the Treatment Period
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Assessment method [15]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [15]
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Baseline and Week 48
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Secondary outcome [16]
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Mean Change From Week 17 to Week 48 in ARC During the Open-label Period
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Assessment method [16]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [16]
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Week 17 and Week 48
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Secondary outcome [17]
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Mean Change From Baseline to Week 48 in LDH Level During the Treatment Period
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Assessment method [17]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [17]
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Baseline and Week 48
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Secondary outcome [18]
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Mean Change From Week 17 to Week 48 in LDH Level During the Open-label Period
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Assessment method [18]
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Baseline was the average of available measurements recorded from central laboratory before taking the first dose of pegcetacoplan. Analysis excluded data before the RCP and was censored for transfusions.
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Timepoint [18]
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Week 17 and Week 48
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Secondary outcome [19]
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Mean Change From Baseline to Week 48 in FACIT-Fatigue Scale Score During the Treatment Period
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Assessment method [19]
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0
The FACIT-fatigue scale version 4 is a 13-item Likert scaled instrument where the subject was presented with 13 statements and asked to indicate their response as it applied to the past 7 days. The 5 possible responses were 'Not at all' (0), 'A little bit (1), 'Somewhat' (2), 'Quite a bit' (3) and 'Very much' (4). With 13 statements the total score had a range of 0 to 52. A higher score corresponds to a higher QoL. Baseline was the last available, nonmissing observation before taking the first dose of pegcetacoplan. Data collected after transfusion is excluded from analysis.
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Timepoint [19]
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Baseline and Week 48
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Secondary outcome [20]
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Mean Change From Week 17 to Week 48 in FACIT-Fatigue Scale Score During the Open-label Period
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Assessment method [20]
0
0
The FACIT-fatigue scale is a 13 item Likert scaled instrument where the subject was presented with 13 statements and asked to indicate their response as it applied to the past 7 days. The 5 possible responses were 'Not at all' (0), 'A little bit (1), 'Somewhat' (2), 'Quite a bit' (3) and 'Very much' (4). With 13 statements the total score had a range of 0 to 52. Higher score corresponds to a higher QoL.
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Timepoint [20]
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0
Week 17 and Week 48
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Secondary outcome [21]
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Mean Change From Baseline to Week 48 in LASA Scores During the Treatment Period
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Assessment method [21]
0
0
The LASA consists of 3 items, where the respondents were asked to rate their perceived level of functioning. Specific domains included activity level, ability to carry out daily activities, and an item for overall QoL. Their level of functioning was reported on a 0 to 100 scale with 0 indicates "As low as could be" and 100 indicates "As high as could be". The combined score ranged from 0 to 300, with higher scores corresponding to a higher QoL.
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Timepoint [21]
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Baseline and Week 48
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Secondary outcome [22]
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Mean Change From Week 17 to Week 48 in LASA Scores During the Open-label Period
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Assessment method [22]
0
0
The FACIT-fatigue scale is a 13 item Likert scaled instrument where the subject was presented with 13 statements and asked to indicate their response as it applied to the past 7 days. The 5 possible responses were 'Not at all' (0), 'A little bit (1), 'Somewhat' (2), 'Quite a bit' (3) and 'Very much' (4). With 13 statements the total score had a range of 0 to 52. Higher score corresponds to a higher QoL.
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Timepoint [22]
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Week 17 and Week 48
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Secondary outcome [23]
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Mean Change From Baseline to Week 48 in QLQ-C30 Scores During the Treatment Period
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Assessment method [23]
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0
The EORTC QLQ-C30 questionnaire (version 3.0) consists of 30 questions comprised of both multi-item scales and single-item measures to assess overall QoL in subjects. Questions are designated by functional scales, symptom scales, and global subject QoL/overall perceived health status. For the first 28 questions the 4 possible responses are 'Not at all' (1), 'A little' (2), 'Quite a bit' (3) and 'Very much' (4). For the remaining 2 questions the response is requested on a 7-point scale from 1 ('Very poor') to 7 ('Excellent'). The raw scale scores were linear transformed, producing scale scores that ranged from 0% to 100%. A high scale score represents a higher response level. Hence for the functional scales and the global health status a higher score indicates a better QoL, whilst for the symptom scale scores this is implied by a lower score.
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Timepoint [23]
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0
Baseline and Week 48
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Secondary outcome [24]
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Mean Change From Week 17 to Week 48 in QLQ-C30 Scores During the Open-label Period
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Assessment method [24]
0
0
The EORTC QLQ-C30 questionnaire (version 3.0) consists of 30 questions comprised of both multi-item scales and single-item measures to assess overall QoL in subjects. Questions are designated by functional scales, symptom scales, and global subject QoL/overall perceived health status. For the first 28 questions the 4 possible responses are 'Not at all' (1), 'A little' (2), 'Quite a bit' (3) and 'Very much' (4). For the remaining 2 questions the response is requested on a 7-point scale from 1 ('Very poor') to 7 ('Excellent'). The raw scale scores were linear transformed, producing scale scores that ranged from 0% to 100%. A high scale score represents a higher response level. Hence for the functional scales and the global health status a higher score indicates a better QoL, whilst for the symptom scale scores this is implied by a lower score.
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Timepoint [24]
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Week 17 and Week 48
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Secondary outcome [25]
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Total Number of PRBC Units Transfused During the Open-Label Period
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Assessment method [25]
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Number of units of PRBC transfused to subjects in the open-label period are reported.
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Timepoint [25]
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Week 17 to Week 48
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Eligibility
Key inclusion criteria
- At least 18 years of age
- Primary diagnosis of PNH confirmed by high-sensitivity flow cytometry
- On treatment with eculizumab. Dose of eculizumab must have been stable for at least 3
months prior to the Screening Visit
- Hb <10.5 g/dL at the Screening Visit
- Absolute reticulocyte count > 1.0x ULN at the Screening Visit
- Platelet count of >50,000/mm3 at the Screening Visit
- Absolute neutrophil count >500/mm3 at the Screening Visit
- Vaccination against Neisseria meningitides types A, C, W, Y and B, Streptococcus
pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day
1 dosing, or within 14 days after starting treatment with APL-2. Unless documented
evidence exists that subjects are non-responders to vaccination as evidenced by titers
or display titer levels within acceptable local limits
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the
Screening and Day -28 Visit (Run-in Period) and must agree to use protocol defined
methods of contraception for the duration of the study and 90 days after their last
dose of study drug
- Males must agree to use protocol defined methods of contraception and agree to refrain
from donating sperm for the duration of the study and 90 days after their last dose of
study drug
- Willing and able to give informed consent
- Willing and able to self-administer APL-2 (administration by caregiver will be
allowed)
- Have a body mass index (BMI) =35.0 kg/m2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Active bacterial infection that has not resolved within 14 week of Day -28 (first dose
of APL-2)
- Receiving iron, folic acid, vitamin B12 and EPO, unless the dose is stable, in the 4
weeks prior to Screening
- Hereditary complement deficiency
- History of bone marrow transplantation
- History or presence of hypersensitivity or idiosyncratic reaction to compounds related
to the investigational product or SC administration
- Participation in any other investigational drug trial or exposure to other
investigational agent within 30 days or 5 half-lives (whichever is longer)
- Currently breast-feeding women
- Inability to cooperate or any condition that, in the opinion of the investigator,
could increase the subject's risk of participating in the study or confound the
outcome of the study
This study includes cardiac safety evaluations. The following cardiac eligibility criteria
are necessary to avoid confounding the cardiac safety outcomes:
- History or family history of Long QT Syndrome or torsade de pointes, unexplained
syncope, syncope from an uncorrected cardiac etiology, or family history of sudden
death
- Myocardial infarction, CABG, coronary or cerebral artery stenting and /or angioplasty,
stroke, cardiac surgery, or hospitalization for congestive heart failure within 3
months or greater than Class 2 Angina Pectoris or NYHA Heart Failure Class >2
- QTcF > 470 ms, PR > 280 ms
- Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or Complete Heart
Block unless the patient has an implanted pacemaker or implantable cardiac
defibrillator (ICD) with backup pacing capabilities
- Receiving Class 1 or Class 3 antiarrhythmic agents, or arsenic, methadone, ondansetron
or pentamidine at screening
- Receiving any other QTc-prolonging drugs (see Appendix 4 in Section 19.4), at a stable
dose for less than 3 weeks prior to dosing
- Receiving prophylactic ciprofloxacin, erythromycin or azithromycin for less than one
week prior to the first dose of study medication (must have a repeat screening ECG
after one week of prophylactic antibiotics with QTcF < 470 ms)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/08/2020
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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0
3000 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
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0
District of Columbia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New York
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Country [10]
0
0
United States of America
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State/province [10]
0
0
North Carolina
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Oregon
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Tennessee
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Texas
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Country [14]
0
0
Belgium
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State/province [14]
0
0
Vlaams-Brabant
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Country [15]
0
0
Belgium
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State/province [15]
0
0
West-Vlaanderen
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Country [16]
0
0
Canada
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State/province [16]
0
0
Alberta
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Country [17]
0
0
Canada
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State/province [17]
0
0
Ontario
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Country [18]
0
0
France
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State/province [18]
0
0
Annecy
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Country [19]
0
0
France
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State/province [19]
0
0
Chalon-sur-Saône
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Country [20]
0
0
France
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State/province [20]
0
0
Lille
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Country [21]
0
0
France
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State/province [21]
0
0
Marseille
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Country [22]
0
0
France
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State/province [22]
0
0
Paris
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Country [23]
0
0
France
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State/province [23]
0
0
Pierre-Bénite
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Country [24]
0
0
France
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State/province [24]
0
0
Saint-Quentin
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Country [25]
0
0
France
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State/province [25]
0
0
Toulouse
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Country [26]
0
0
Germany
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State/province [26]
0
0
Baden-Württemberg
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Country [27]
0
0
Germany
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State/province [27]
0
0
North Rhine-Westphalia
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Country [28]
0
0
Germany
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State/province [28]
0
0
Hamburg
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Country [29]
0
0
Japan
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State/province [29]
0
0
Aichi
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Country [30]
0
0
Japan
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State/province [30]
0
0
Ibaraki
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Country [31]
0
0
Japan
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State/province [31]
0
0
Nagano
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Country [32]
0
0
Japan
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State/province [32]
0
0
Okayama
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Country [33]
0
0
Japan
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State/province [33]
0
0
Tokyo
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Country [34]
0
0
Japan
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State/province [34]
0
0
Wakayama
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Country [35]
0
0
Korea, Republic of
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State/province [35]
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0
Bucheon
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Country [36]
0
0
Korea, Republic of
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State/province [36]
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0
Daejeon
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Country [37]
0
0
Korea, Republic of
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State/province [37]
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0
Seoul
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Country [38]
0
0
Russian Federation
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State/province [38]
0
0
Saint Petersburg
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Country [39]
0
0
Russian Federation
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State/province [39]
0
0
Tyumen
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Country [40]
0
0
Spain
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State/province [40]
0
0
Las Palmas De Gran Canaria
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Country [41]
0
0
Spain
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State/province [41]
0
0
Valencia
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Country [42]
0
0
United Kingdom
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State/province [42]
0
0
Leeds
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Apellis Pharmaceuticals, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal
Hemoglobinuria
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03500549
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Public notes
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Contacts
Principal investigator
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03500549
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