Trial Outcomes & Findings for Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients (NCT NCT03927144)

Last Updated: 2023-11-18

Results Overview

A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia If the participant took a migraine-specific medication (ie, triptan or ergotamine) during aura, or to treat a headache on a calendar day, then it was counted as a migraine day regardless of the duration and pain features/associated symptoms. In addition to achieving at least a 50% reduction from baseline in monthly migraine days, participants must have also completed their initially assigned treatment through Month 12.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

621 participants

Primary outcome timeframe

Baseline and Month 12

Results posted on

2023-11-18

Participant Flow

621 participants were enrolled at 84 centers in Argentina, Austria, Belgium, Czechia, Finland, France, Germany, Greece, Israel, Italy, the Netherlands, Poland, Portugal, Slovakia, Spain, the United Kingdom and the United States. The primary completion date based on the Core Phase was 01-Oct-2021. The study completion date was 30-Sep-2022.

Participants were randomized 2:1 \[AMG334 70/140 mg: oral prophylactic\]. Randomization was stratified by prior prophylactic migraine medication treatment failure (due to insufficient efficacy or poor tolerability) reported during Screening/Baseline Period: 1 treatment failure (TF1) vs 2 treatment failures (TF2). A 30% cap of randomized participants to the TF2 strata was implemented. The stratification and 30% cap were implemented within Interactive Response Technology.

Participant milestones

Participant milestones
Measure	AMG334 70 mg/140 mg Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Core Phase STARTED	413	208
Core Phase COMPLETED	377	146
Core Phase NOT COMPLETED	36	62
Extension Phase STARTED	343	118
Extension Phase COMPLETED	328	108
Extension Phase NOT COMPLETED	15	10

Reasons for withdrawal

Reasons for withdrawal
Measure	AMG334 70 mg/140 mg Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Core Phase Adverse Event	9	5
Core Phase Lost to Follow-up	3	2
Core Phase New Therapy for Study Indication	0	1
Core Phase No Longer Clinically Benefiting	4	4
Core Phase Physician Decision	2	8
Core Phase Protocol Violation	2	2
Core Phase Withdrawal by Subject	16	40
Extension Phase Adverse Event	2	1
Extension Phase No longer clinically benefiting	4	5
Extension Phase Pregnancy	1	0
Extension Phase Protocol Violation	0	1
Extension Phase Withdrawal by Subject	8	3

Baseline Characteristics

Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMG334 70 mg/140 mg n=413 Participants Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic n=208 Participants Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Total n=621 Participants Total of all reporting groups
Age, Continuous	41.1 years STANDARD_DEVIATION 11.5 • n=5 Participants	41.5 years STANDARD_DEVIATION 10.4 • n=7 Participants	41.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	363 Participants n=5 Participants	182 Participants n=7 Participants	545 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	26 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	406 Participants n=5 Participants	206 Participants n=7 Participants	612 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	381 Participants n=5 Participants	190 Participants n=7 Participants	571 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 12

Population: FAS: Included all participants to whom study treatment had been assigned.

Outcome measures

Outcome measures
Measure	AMG334 70 mg/140 mg n=413 Participants Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic n=208 Participants Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Number of Participants Who Completed Initially Assigned Treatment and Achieved at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 12	232 Participants	35 Participants

SECONDARY outcome

Timeframe: Month 12

Population: FAS: Included all participants to whom study treatment has been assigned.

Outcome measures

Outcome measures
Measure	AMG334 70 mg/140 mg n=413 Participants Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic n=208 Participants Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Number of Participants Who Completed Initially Assigned Treatment at Month 12	359 Participants	78 Participants

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, and Week 52

Population: Participants in the FAS with data available at each time point. The FAS included all participants to whom study treatment had been assigned. All participants included in the overall number of participants analyzed contributed to the post-baseline data for this endpoint.

A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). The mean of monthly migraine days was obtained cumulatively every 4 weeks across 52 weeks (for example, at Week 8 the mean will be based on data from Week 1 to Week 8; and at Week 12 the mean will be based on data from Week 1 to Week 12). The cumulative mean change from baseline in monthly migraine days was derived using difference between cumulative average of each month and baseline monthly migraine days.

Outcome measures

Outcome measures
Measure	AMG334 70 mg/140 mg n=413 Participants Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic n=208 Participants Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 4	-2.55 migraine days per month Standard Error 0.17	-0.55 migraine days per month Standard Error 0.25
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 8	-3.00 migraine days per month Standard Error 0.17	-1.01 migraine days per month Standard Error 0.25
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 12	-3.27 migraine days per month Standard Error 0.17	-1.05 migraine days per month Standard Error 0.26
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 16	-3.45 migraine days per month Standard Error 0.17	-1.22 migraine days per month Standard Error 0.26
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 20	-3.63 migraine days per month Standard Error 0.17	-1.35 migraine days per month Standard Error 0.26
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 24	-3.75 migraine days per month Standard Error 0.17	-1.56 migraine days per month Standard Error 0.26
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 28	-3.84 migraine days per month Standard Error 0.17	-1.73 migraine days per month Standard Error 0.26
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 32	-3.93 migraine days per month Standard Error 0.17	-1.91 migraine days per month Standard Error 0.27
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 36	-3.99 migraine days per month Standard Error 0.17	-1.99 migraine days per month Standard Error 0.27
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 40	-4.05 migraine days per month Standard Error 0.17	-2.06 migraine days per month Standard Error 0.27
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 44	-4.12 migraine days per month Standard Error 0.17	-2.11 migraine days per month Standard Error 0.27
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 48	-4.18 migraine days per month Standard Error 0.17	-2.07 migraine days per month Standard Error 0.27
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52 Week 52	-4.24 migraine days per month Standard Error 0.17	-2.11 migraine days per month Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: FAS: Included all participants to whom study treatment had been assigned.

The PGIC scale consists of one item which measures the participants' perception of change in their condition relative to the beginning of the study. Responses are rated on a 7-item response scale ranging from very much improved (7) to no change or worsened condition (1). A responder was defined as a participant with a PGIC score of at least 5 (5=moderately better, 6=better, 7=a great deal better), at Week 52 for participants who completed the treatment period at Week 52 on the initially assigned treatment.

Outcome measures

Outcome measures
Measure	AMG334 70 mg/140 mg n=413 Participants Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Oral Prophylactic n=208 Participants Participants received a standard of care (SOC) approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Number of Responders as Measured by the Patient's Global Impression of Change (PGIC) Scale at Week 52	314 Participants	39 Participants

Adverse Events

Core Phase: AMG334 70mg/140mg

Serious events: 15 serious events

Other events: 131 other events

Deaths: 0 deaths

Core Phase: Oral Prophylactics

Serious events: 9 serious events

Other events: 91 other events

Deaths: 0 deaths

Extension Phase: AMG334 70mg/140mg Continuing on AMG334 70mg/140mg

Serious events: 9 serious events

Other events: 106 other events

Deaths: 0 deaths

Extension Phase: Oral Prophylactics Then AMG334 70mg/140mg

Serious events: 4 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Core Phase: AMG334 70mg/140mg n=408 participants at risk Participants received 70 mg or 140 mg of AMG334 as a subcutaneous injection once per month for 52 weeks in the Core Phase. Participants were permitted to switch to an approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Includes 9 participants who switched from AMG334 to SOC oral prophylactics during the core phase; only AEs prior to the treatment switch to SOC oral prophylactics are reported.	Core Phase: Oral Prophylactics n=206 participants at risk Participants received a SOC approved oral prophylactic once per day for 52 weeks in the Core Phase, as prescribed per local country labels. Participants were permitted to switch to a different approved oral prophylactic based on treatment failure status and at the investigator's and participant's discretion. Includes 9 participants who switched from AMG334 to SOC oral prophylactics during the core phase; only AEs following the treatment switch to SOC oral prophylactics are reported.	Extension Phase: AMG334 70mg/140mg Continuing on AMG334 70mg/140mg n=343 participants at risk Eligible Core Phase completers (completed Week 52 and were benefitting from AMG334 treatment) entered the Extension Phase to continue to receive 70 mg or 140 mg AMG334 for up to 52 weeks.	Extension Phase: Oral Prophylactics Then AMG334 70mg/140mg n=118 participants at risk Eligible Core Phase completers (completed Week 52 and were in need of a treatment switch) who received a SOC approved oral prophylactic in the Core Phase entered the Extension Phase to receive 70 mg or 140 mg AMG334 for up to 52 weeks.
Gastrointestinal disorders Constipation	13.0% 53/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.97% 2/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	2.9% 10/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	13.6% 16/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
General disorders Fatigue	4.4% 18/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	16.0% 33/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	1.2% 4/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	1.7% 2/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Infections and infestations COVID-19	4.9% 20/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	5.8% 12/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	17.8% 61/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	15.3% 18/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	8.8% 36/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	7.3% 15/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	8.2% 28/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	8.5% 10/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Vaccination complication	2.2% 9/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.97% 2/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	4.7% 16/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	6.8% 8/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Investigations Weight increased	2.9% 12/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	10.7% 22/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.00% 0/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	1.7% 2/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	1.7% 7/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	8.7% 18/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	1.7% 6/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.85% 1/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Nervous system disorders Paraesthesia	1.2% 5/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	7.3% 15/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.87% 3/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.85% 1/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.
Nervous system disorders Somnolence	1.2% 5/408 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	7.3% 15/206 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	0.00% 0/343 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.	1.7% 2/118 • Day 1 to Week 52 of the Core Phase and Day 1 to Week 52 of the Extension Phase An adverse event (AE) was defined as any untoward medical occurrence (e.g., any unfavorable \& unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant after the first dose of study treatment. AEs were collected based on treatment type received (AMG334 versus oral prophylactic) and were not collected separately for each dose. The Safety Set: Included all participants who received at least one dose of study treatment.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER