Trial Outcomes & Findings for Eptinezumab in Participants With Episodic Cluster Headache (NCT NCT04688775)
NCT ID: NCT04688775
Last Updated: 2024-08-09
Results Overview
The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response.
COMPLETED
PHASE3
231 participants
Baseline (Week 0), Weeks 1-2
2024-08-09
Participant Flow
Participant milestones
| Measure |
Eptinezumab
Participants received a single intravenous (IV) infusion of eptinezumab 400 milligrams (mg) in 100 milliliters (mL) 0.9% saline solution.
|
Placebo
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Delayed Start Period: Placebo to Eptinezumab
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Delayed Start Period: Eptinezumab to Placebo
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
|---|---|---|---|---|
|
Placebo-controlled Period
STARTED
|
113
|
118
|
0
|
0
|
|
Placebo-controlled Period
Received at Least 1 Dose of Study Drug
|
112
|
117
|
0
|
0
|
|
Placebo-controlled Period
COMPLETED
|
108
|
107
|
0
|
0
|
|
Placebo-controlled Period
NOT COMPLETED
|
5
|
11
|
0
|
0
|
|
Delayed Start Period
STARTED
|
0
|
0
|
107
|
108
|
|
Delayed Start Period
Received at Least 1 Dose of Study Drug
|
0
|
0
|
107
|
108
|
|
Delayed Start Period
COMPLETED
|
0
|
0
|
101
|
100
|
|
Delayed Start Period
NOT COMPLETED
|
0
|
0
|
6
|
8
|
Reasons for withdrawal
| Measure |
Eptinezumab
Participants received a single intravenous (IV) infusion of eptinezumab 400 milligrams (mg) in 100 milliliters (mL) 0.9% saline solution.
|
Placebo
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Delayed Start Period: Placebo to Eptinezumab
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Delayed Start Period: Eptinezumab to Placebo
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
|---|---|---|---|---|
|
Placebo-controlled Period
Randomized, not treated
|
1
|
1
|
0
|
0
|
|
Placebo-controlled Period
Adverse Event
|
2
|
0
|
0
|
0
|
|
Placebo-controlled Period
Lack of Efficacy
|
1
|
2
|
0
|
0
|
|
Placebo-controlled Period
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Placebo-controlled Period
Withdrawal by Subject
|
1
|
6
|
0
|
0
|
|
Placebo-controlled Period
Other reasons
|
0
|
1
|
0
|
0
|
|
Delayed Start Period
Adverse Event
|
0
|
0
|
1
|
0
|
|
Delayed Start Period
Lack of Efficacy
|
0
|
0
|
0
|
3
|
|
Delayed Start Period
Withdrawal by Subject
|
0
|
0
|
2
|
4
|
|
Delayed Start Period
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Delayed Start Period
other reasons
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The APTS included all randomized participants in the who received infusion with double-blind IMP.
Baseline characteristics by cohort
| Measure |
Eptinezumab
n=113 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=118 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.17 years
STANDARD_DEVIATION 11.099 • n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
43.94 years
STANDARD_DEVIATION 11.019 • n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
44.05 years
STANDARD_DEVIATION 11.035 • n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Sex: Female, Male
Female
|
27 Participants
n=112 Participants • The APTS included all randomized participants who received infusion with double-blind investigational medicinal product (IMP).
|
24 Participants
n=117 Participants • The APTS included all randomized participants who received infusion with double-blind investigational medicinal product (IMP).
|
51 Participants
n=229 Participants • The APTS included all randomized participants who received infusion with double-blind investigational medicinal product (IMP).
|
|
Sex: Female, Male
Male
|
85 Participants
n=112 Participants • The APTS included all randomized participants who received infusion with double-blind investigational medicinal product (IMP).
|
93 Participants
n=117 Participants • The APTS included all randomized participants who received infusion with double-blind investigational medicinal product (IMP).
|
178 Participants
n=229 Participants • The APTS included all randomized participants who received infusion with double-blind investigational medicinal product (IMP).
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
4 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
8 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
1 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Race/Ethnicity, Customized
White
|
97 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
103 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
200 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
2 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
3 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
9 Participants
n=112 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
8 Participants
n=117 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
17 Participants
n=229 Participants • The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Number of Weekly Cluster Headache (CH) Attacks
|
15.2 Number of Weekly Attacks
STANDARD_DEVIATION 8.07 • n=113 Participants • The APRS included all randomized participants.
|
15.7 Number of Weekly Attacks
STANDARD_DEVIATION 8.28 • n=118 Participants • The APRS included all randomized participants.
|
15.4 Number of Weekly Attacks
STANDARD_DEVIATION 8.17 • n=231 Participants • The APRS included all randomized participants.
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The APRS included all randomized participants.
The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response.
Outcome measures
| Measure |
Eptinezumab
n=113 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=118 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2
|
-4.0 Number of Weekly Attacks
Standard Error 0.93
|
-4.6 Number of Weekly Attacks
Standard Error 0.89
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The APRS included all randomized participants.
Outcome measures
| Measure |
Eptinezumab
n=113 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=118 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
|
44 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Abortive medications included the use of triptans or oxygen (O2).
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2
|
-2.54 Abortive therapy use per week
Standard Error 0.98
|
-3.55 Abortive therapy use per week
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Days 1-3Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=110 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=115 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
|
-0.22 Attacks per day
Standard Error 0.16
|
-0.35 Attacks per day
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2
|
0.60 Days
Standard Error 0.20
|
0.82 Days
Standard Error 0.19
|
SECONDARY outcome
Timeframe: From first infusion (Baseline, Day 0) to 4 weeksPopulation: The APRS included all randomized participants.
Presented here is the result of the analysis of time from first infusion of IMP to resolution of cluster headache bout. The hazard ratio estimate is an estimate from the Cox model of time to resolution.
Outcome measures
| Measure |
Eptinezumab
n=112 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=117 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks
|
NA days
Median and 95% CI could not be calculated due to insufficient number of events
|
NA days
Median and 95% CI could not be calculated due to insufficient number of events
|
SECONDARY outcome
Timeframe: From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled periodPopulation: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=104 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=110 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP
|
2.07 Number of attacks
Standard Error 0.18
|
1.96 Number of attacks
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Days 1-3Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The severity of pain was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
Outcome measures
| Measure |
Eptinezumab
n=99 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=112 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3
|
-0.30 score on a scale
Standard Error 0.10
|
-0.18 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 1Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline to Week 1 in the Number of Weekly Attacks
|
-2.62 Attacks per week
Standard Error 0.95
|
-3.71 Attacks per week
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 2Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=106 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=110 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline to Week 2 in the Number of Weekly Attacks
|
-5.44 Attacks per week
Standard Error 1.00
|
-5.64 Attacks per week
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 1Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1
|
36 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 1Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1
|
48 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The APRS included all randomized participants.
Outcome measures
| Measure |
Eptinezumab
n=113 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=118 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
|
59 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2
|
-13.39 score on a scale
Standard Error 2.56
|
-14.46 score on a scale
Standard Error 2.43
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 1Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain
|
-10.58 score on a scale
Standard Error 2.55
|
-11.96 score on a scale
Standard Error 2.42
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 2Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Outcome measures
| Measure |
Eptinezumab
n=106 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=110 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain
|
-16.20 score on a scale
Standard Error 2.73
|
-16.95 score on a scale
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
|
-5.95 Attacks per week
Standard Error 0.92
|
-5.78 Attacks per week
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The weekly integrated measure of frequency and intensity of pain score calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4
|
-17.81 score on a scale
Standard Error 2.50
|
-16.81 score on a scale
Standard Error 2.37
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, and 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
Outcome measures
| Measure |
Eptinezumab
n=101 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=116 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4
Week 1
|
-0.33 score on a scale
Standard Error 0.09
|
-0.24 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4
Week 2
|
-0.46 score on a scale
Standard Error 0.10
|
-0.35 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4
Week 3
|
-0.56 score on a scale
Standard Error 0.11
|
-0.31 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4
Week 4
|
-0.51 score on a scale
Standard Error 0.11
|
-0.42 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 3-4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
Outcome measures
| Measure |
Eptinezumab
n=104 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=112 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4
Week 3
|
-7.35 Attacks per week
Standard Error 0.98
|
-6.60 Attacks per week
Standard Error 0.94
|
|
Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4
Week 4
|
-8.37 Attacks per week
Standard Error 1.11
|
-7.15 Attacks per week
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Weeks 1, 2, and 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.
Outcome measures
| Measure |
Eptinezumab
n=104 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=106 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
Week 1
|
3.19 score on a scale
Standard Error 0.16
|
3.55 score on a scale
Standard Error 0.15
|
|
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
Week 2
|
2.92 score on a scale
Standard Error 0.17
|
3.44 score on a scale
Standard Error 0.16
|
|
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
Week 4
|
2.85 score on a scale
Standard Error 0.18
|
3.23 score on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 2 and 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.
Outcome measures
| Measure |
Eptinezumab
n=100 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=102 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Daily Activities - Week 2
|
16.83 score on a scale
Standard Error 3.08
|
8.93 score on a scale
Standard Error 3.06
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Daily Activities - Week 4
|
24.82 score on a scale
Standard Error 3.19
|
13.97 score on a scale
Standard Error 3.08
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Emotional Well-being - Week 2
|
14.85 score on a scale
Standard Error 2.84
|
6.04 score on a scale
Standard Error 2.81
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Emotional Well-being - Week 4
|
22.77 score on a scale
Standard Error 3.07
|
12.22 score on a scale
Standard Error 2.97
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Energy/Fatigue - Week 2
|
18.16 score on a scale
Standard Error 3.23
|
8.03 score on a scale
Standard Error 3.19
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Energy/Fatigue - Week 4
|
24.16 score on a scale
Standard Error 3.47
|
14.68 score on a scale
Standard Error 3.36
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Mental Fatigue - Week 2
|
9.04 score on a scale
Standard Error 2.66
|
4.15 score on a scale
Standard Error 2.64
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Mental Fatigue - Week 4
|
15.15 score on a scale
Standard Error 2.91
|
8.00 score on a scale
Standard Error 2.81
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Emotional Impact - Week 2
|
14.39 score on a scale
Standard Error 3.02
|
6.00 score on a scale
Standard Error 3.00
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Emotional Impact - Week 4
|
23.09 score on a scale
Standard Error 3.29
|
13.36 score on a scale
Standard Error 3.18
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Social Well-being - Week 2
|
15.22 score on a scale
Standard Error 3.37
|
6.92 score on a scale
Standard Error 3.35
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Social Well-being - Week 4
|
23.74 score on a scale
Standard Error 3.46
|
13.91 score on a scale
Standard Error 3.35
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Satisfaction with Sleep - Week 2
|
-11.41 score on a scale
Standard Error 2.75
|
-6.06 score on a scale
Standard Error 2.73
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Satisfaction with Sleep - Week 4
|
-19.60 score on a scale
Standard Error 2.88
|
-9.63 score on a scale
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 2 and 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number Analyzed" is the number of participants evaluable at the specified time point.
The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
| Measure |
Eptinezumab
n=76 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=80 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
Week 2
|
8.21 score on a scale
Standard Error 2.79
|
3.47 score on a scale
Standard Error 2.86
|
|
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
Week 4
|
13.49 score on a scale
Standard Error 2.80
|
5.73 score on a scale
Standard Error 2.77
|
SECONDARY outcome
Timeframe: Week 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
Number of participants who visited a family doctor/general practitioner has been reported.
Outcome measures
| Measure |
Eptinezumab
n=100 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=104 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
0 visits
|
85 Participants
|
85 Participants
|
|
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
1 visit
|
9 Participants
|
10 Participants
|
|
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
2 visits
|
1 Participants
|
6 Participants
|
|
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
3 visits
|
3 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
5 visits
|
1 Participants
|
1 Participants
|
|
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
6 visits
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
Number of participants who visited a specialist has been reported.
Outcome measures
| Measure |
Eptinezumab
n=100 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=104 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
HCRU Score: Number of Visits to a Specialist
0 visits
|
77 Participants
|
68 Participants
|
|
HCRU Score: Number of Visits to a Specialist
1 visit
|
11 Participants
|
18 Participants
|
|
HCRU Score: Number of Visits to a Specialist
2 visits
|
6 Participants
|
14 Participants
|
|
HCRU Score: Number of Visits to a Specialist
3 visits
|
4 Participants
|
2 Participants
|
|
HCRU Score: Number of Visits to a Specialist
4 visits
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
Number of participants who visited an emergency department due to CH was reported.
Outcome measures
| Measure |
Eptinezumab
n=100 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=104 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
0 visits
|
98 Participants
|
99 Participants
|
|
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
1 visit
|
1 Participants
|
2 Participants
|
|
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
2 visits
|
1 Participants
|
2 Participants
|
|
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
3 visits
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
Number of participants who were admitted to a hospital due to CH was reported.
Outcome measures
| Measure |
Eptinezumab
n=100 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=104 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
HCRU Score: Number of Hospital Admissions Due to Cluster Headache
0 admissions
|
97 Participants
|
102 Participants
|
|
HCRU Score: Number of Hospital Admissions Due to Cluster Headache
1 admission
|
1 Participants
|
0 Participants
|
|
HCRU Score: Number of Hospital Admissions Due to Cluster Headache
2 admissions
|
2 Participants
|
1 Participants
|
|
HCRU Score: Number of Hospital Admissions Due to Cluster Headache
3 admissions
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point.
Number of participants who stayed overnight in a hospital due to CH was reported.
Outcome measures
| Measure |
Eptinezumab
n=100 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=104 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache
5 overnight hospital stays
|
1 Participants
|
0 Participants
|
|
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache
0 overnight hospital stays
|
99 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4Population: The APRS included all randomized participants. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure and "Number Analyzed" is the number of participants evaluable for each specified category.
The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons; and 2 visual numerical scales assess how much the participant's condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.
Outcome measures
| Measure |
Eptinezumab
n=95 Participants
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo
n=95 Participants
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|
|
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
Absenteeism
|
-13.71 score on a scale
Standard Error 3.95
|
-4.37 score on a scale
Standard Error 3.74
|
|
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
Presenteeism
|
-19.29 score on a scale
Standard Error 4.81
|
-11.03 score on a scale
Standard Error 4.68
|
|
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
Work productivity loss
|
-23.59 score on a scale
Standard Error 5.34
|
-13.68 score on a scale
Standard Error 5.20
|
|
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
Activity impairment
|
-25.84 score on a scale
Standard Error 3.70
|
-15.82 score on a scale
Standard Error 3.58
|
Adverse Events
Placebo-controlled Period: Eptinezumab
Placebo-controlled Period: Placebo
Delayed Start Period: Eptinezumab to Placebo
Delayed Start Period: Placebo to Eptinezumab
Serious adverse events
| Measure |
Placebo-controlled Period: Eptinezumab
n=112 participants at risk
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo-controlled Period: Placebo
n=117 participants at risk
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Delayed Start Period: Eptinezumab to Placebo
n=108 participants at risk
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Delayed Start Period: Placebo to Eptinezumab
n=107 participants at risk
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/112 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/117 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/108 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.93%
1/107 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Immune system disorders
Hypersensitivity
|
0.89%
1/112 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/117 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/108 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Infections and infestations
Meningitis enteroviral
|
0.00%
0/112 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/117 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.93%
1/108 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/112 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/117 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.93%
1/108 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.89%
1/112 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/117 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/108 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Reproductive system and breast disorders
Cystocele
|
0.89%
1/112 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/117 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/108 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
Other adverse events
| Measure |
Placebo-controlled Period: Eptinezumab
n=112 participants at risk
Participants received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Placebo-controlled Period: Placebo
n=117 participants at risk
Participants received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
Delayed Start Period: Eptinezumab to Placebo
n=108 participants at risk
Participants who received placebo in the placebo-controlled period received a single IV infusion of eptinezumab 400mg in 100 mL 0.9% saline solution.
|
Delayed Start Period: Placebo to Eptinezumab
n=107 participants at risk
Participants who received eptinezumab in the placebo-controlled period received a single IV infusion of 0.9% saline solution as matching placebo for eptinezumab.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.6%
4/112 • Number of events 4 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
1.7%
2/117 • Number of events 3 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
2.8%
3/108 • Number of events 4 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
General disorders
Fatigue
|
3.6%
4/112 • Number of events 4 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.85%
1/117 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/108 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.93%
1/107 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Infections and infestations
COVID-19
|
0.89%
1/112 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
2.6%
3/117 • Number of events 3 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
6.5%
7/108 • Number of events 7 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
1.9%
2/107 • Number of events 3 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
2/112 • Number of events 2 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
2.6%
3/117 • Number of events 3 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
1.9%
2/108 • Number of events 2 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
5.6%
6/107 • Number of events 6 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/112 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.85%
1/117 • Number of events 1 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
2.8%
3/108 • Number of events 3 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
0.00%
0/107 • From date of first dose of IMP to 20 weeks after last dose (up to 24 weeks)
The APTS included all randomized participants in the who received infusion with double-blind IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place