Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine (NCT NCT05458011)
NCT ID: NCT05458011
Last Updated: 2025-11-26
Results Overview
A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
365 participants
Primary outcome timeframe
Baseline (Day -28 to Day -1), up to Week 12
Results posted on
2025-11-26
Participant Flow
A total of 454 participants were screened; of which 365 participants were randomized and included in the analysis.
Participant milestones
| Measure |
Placebo
Double-blind (DB) Period: Participants received placebo subcutaneously (SC) once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
Open-label (OL) Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Fremanezumab Monthly
DB Period: Participants received fremanezumab SC once a month (approximately every 4 weeks). Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period (12 Weeks)
STARTED
|
183
|
91
|
91
|
|
DB Period (12 Weeks)
DB Safety Analysis Set
|
183
|
91
|
91
|
|
DB Period (12 Weeks)
DB Modified ITT (mITT) Analysis Set
|
182
|
90
|
89
|
|
DB Period (12 Weeks)
COMPLETED
|
177
|
87
|
86
|
|
DB Period (12 Weeks)
NOT COMPLETED
|
6
|
4
|
5
|
|
OL Period (12 Weeks)
STARTED
|
175
|
86
|
85
|
|
OL Period (12 Weeks)
OL Safety Analysis Set
|
175
|
86
|
85
|
|
OL Period (12 Weeks)
COMPLETED
|
174
|
81
|
84
|
|
OL Period (12 Weeks)
NOT COMPLETED
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Double-blind (DB) Period: Participants received placebo subcutaneously (SC) once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
Open-label (OL) Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Fremanezumab Monthly
DB Period: Participants received fremanezumab SC once a month (approximately every 4 weeks). Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period (12 Weeks)
Adverse Event
|
2
|
1
|
1
|
|
DB Period (12 Weeks)
Withdrawal by Subject
|
4
|
1
|
1
|
|
DB Period (12 Weeks)
Non-compliance with trial drug
|
0
|
0
|
1
|
|
DB Period (12 Weeks)
Protocol deviation
|
0
|
2
|
2
|
|
OL Period (12 Weeks)
Adverse Event
|
1
|
2
|
1
|
|
OL Period (12 Weeks)
Withdrawal by Subject
|
0
|
3
|
0
|
Baseline Characteristics
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=183 Participants
DB Period: Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Fremanezumab Monthly
n=91 Participants
DB Period: Participants received fremanezumab SC once a month (approximately every 4 weeks). Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Fremanezumab Quarterly
n=91 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
Total
n=365 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 10.03 • n=492 Participants
|
38.6 years
STANDARD_DEVIATION 9.42 • n=492 Participants
|
39.7 years
STANDARD_DEVIATION 10.89 • n=984 Participants
|
38.9 years
STANDARD_DEVIATION 10.09 • n=3 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=492 Participants
|
71 Participants
n=492 Participants
|
73 Participants
n=984 Participants
|
286 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=492 Participants
|
20 Participants
n=492 Participants
|
18 Participants
n=984 Participants
|
79 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=492 Participants
|
91 Participants
n=492 Participants
|
90 Participants
n=984 Participants
|
364 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
183 Participants
n=492 Participants
|
91 Participants
n=492 Participants
|
91 Participants
n=984 Participants
|
365 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
|
Number of Migraine Days
|
11.0 days
STANDARD_DEVIATION 4.96 • n=492 Participants
|
10.4 days
STANDARD_DEVIATION 5.94 • n=492 Participants
|
10.4 days
STANDARD_DEVIATION 5.20 • n=984 Participants
|
10.7 days
STANDARD_DEVIATION 5.27 • n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -28 to Day -1), up to Week 12Population: DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.
A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).
Outcome measures
| Measure |
Placebo
n=182 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=179 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
Double Blind (DB) Period: Mean Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab
|
-2.8 days/month
Standard Error 0.48
|
-4.6 days/month
Standard Error 0.48
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -28 to Day -1), Up to Week 4Population: DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.
A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) \* 28.
Outcome measures
| Measure |
Placebo
n=182 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=179 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Mean Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
|
-2.2 days
Standard Error 0.52
|
-4.5 days
Standard Error 0.52
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -28 to Day -1), Up to Week 12Population: DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.
Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included opioids, barbiturates, triptans, ergots, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and their combination products. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28.
Outcome measures
| Measure |
Placebo
n=182 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=179 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Mean Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab
|
-1.1 days/month
Standard Error 0.41
|
-3.0 days/month
Standard Error 0.41
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -28 to Day-1), Up to Week 12Population: DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.
A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28.
Outcome measures
| Measure |
Placebo
n=182 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=179 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab
|
63 Participants
|
103 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -28 to Day -1), Up to Week 12Population: DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint. Efficacy analysis was planned to be evaluated combined for both fremanezumab dose treatment groups.
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of headache of at least moderate severity; or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28.
Outcome measures
| Measure |
Placebo
n=182 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=179 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab
|
-2.4 days/month
Standard Error 0.43
|
-4.5 days/month
Standard Error 0.43
|
—
|
SECONDARY outcome
Timeframe: Week 0 up to Week 12Population: DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=91 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=91 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
|
79 Participants
|
48 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Week 0 up to Week 12Population: DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=91 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=91 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Number of Participants Who Did Not Complete the Study Due to AEs
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12 up to Week 24Population: The OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=86 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=85 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
OL Period: Number of Participants With at Least One TEAE
|
78 Participants
|
40 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Week 12 up to Week 24Population: The OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=86 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=85 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
OL Period: Number of Participants Who Did Not Complete the Study Due to AEs
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 0 up to Week 12Population: DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period.
Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=91 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=91 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
DB Period: Number of Participants Who Received Concomitant Medications for AEs
|
51 Participants
|
28 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Week 12 up to Week 24Population: The OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.
Outcome measures
| Measure |
Placebo
n=175 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=86 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=85 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
OL Period: Number of Participants Who Received Concomitant Medications for AEs
|
46 Participants
|
26 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 225Population: Participants who received fremanezumab were analyzed for ADA.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=91 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=91 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADA)
|
28 Participants
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 225Population: Participants who received fremanezumab were analyzed for ADA.
Outcome measures
| Measure |
Placebo
n=183 Participants
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
Fremanezumab Monthly/Quarterly
n=91 Participants
Participants received fremanezumab SC once a month (approximately every 4 weeks) or once a quarter (once at the beginning of the 12-week DB treatment period).
Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57 during Fremanezumab Monthly schedule.
Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57 during Fremanezumab quarterly schedule.
|
Fremanezumab Quarterly
n=91 Participants
DB Period: Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
OL Period: Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Neutralizing Antibodies (NAbs)
|
27 Participants
|
11 Participants
|
9 Participants
|
Adverse Events
DB Period: Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
DB Period: Fremanezumab Monthly
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
DB Period: Fremanezumab Quarterly
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
OL Period: Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
OL Period: Fremanezumab Monthly
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
OL Period: Fremanezumab Quarterly
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Period: Placebo
n=183 participants at risk
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
DB Period: Fremanezumab Monthly
n=91 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks). Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57.
|
DB Period: Fremanezumab Quarterly
n=91 participants at risk
Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
|
OL Period: Placebo
n=175 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
OL Period: Fremanezumab Monthly
n=86 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
OL Period: Fremanezumab Quarterly
n=85 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/183 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.1%
1/91 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/86 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/85 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/183 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.1%
1/91 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/86 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/85 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Infections and infestations
Pneumonia
|
0.55%
1/183 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/86 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.2%
1/85 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/183 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.2%
1/86 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/85 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Nervous system disorders
Headache
|
0.00%
0/183 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.2%
1/86 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/85 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/183 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/86 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.2%
1/85 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/183 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/91 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/175 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/86 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.2%
1/85 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
Other adverse events
| Measure |
DB Period: Placebo
n=183 participants at risk
Participants received placebo SC once a month (approximately every 4 weeks). Participants received 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57.
|
DB Period: Fremanezumab Monthly
n=91 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks). Participants received a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57.
|
DB Period: Fremanezumab Quarterly
n=91 participants at risk
Participants received fremanezumab SC once a quarter (once at the beginning of the 12-week DB treatment period). Participants received 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57.
|
OL Period: Placebo
n=175 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
OL Period: Fremanezumab Monthly
n=86 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
OL Period: Fremanezumab Quarterly
n=85 participants at risk
Participants received fremanezumab SC once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site swelling
|
3.3%
6/183 • Number of events 7 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
5.5%
5/91 • Number of events 7 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
2.2%
2/91 • Number of events 2 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
4.0%
7/175 • Number of events 9 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
7.0%
6/86 • Number of events 8 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
4.7%
4/85 • Number of events 6 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Infections and infestations
COVID-19
|
3.3%
6/183 • Number of events 6 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
5.5%
5/91 • Number of events 5 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
2.2%
2/91 • Number of events 2 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
2.3%
4/175 • Number of events 4 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
0.00%
0/86 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.2%
1/85 • Number of events 2 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
17/183 • Number of events 18 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
9.9%
9/91 • Number of events 9 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
7.7%
7/91 • Number of events 8 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
10.3%
18/175 • Number of events 20 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
9.3%
8/86 • Number of events 9 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
9.4%
8/85 • Number of events 11 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.6%
3/183 • Number of events 3 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.1%
1/91 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
5.5%
5/91 • Number of events 5 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
1.7%
3/175 • Number of events 3 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
10.5%
9/86 • Number of events 9 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
2.4%
2/85 • Number of events 2 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
General disorders
Injection site erythema
|
2.2%
4/183 • Number of events 4 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
5.5%
5/91 • Number of events 8 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
4.4%
4/91 • Number of events 5 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
2.9%
5/175 • Number of events 6 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
7.0%
6/86 • Number of events 12 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
3.5%
3/85 • Number of events 5 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
|
General disorders
Injection site pruritus
|
0.55%
1/183 • Number of events 1 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
6.6%
6/91 • Number of events 9 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
3.3%
3/91 • Number of events 4 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
2.9%
5/175 • Number of events 5 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
5.8%
5/86 • Number of events 12 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
3.5%
3/85 • Number of events 8 • Day 1 up to Day 225
DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER