A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Phase: PHASE2
Conditions: Migraine
Sponsor: Amgen

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Eletriptan hydrobromide 
Relpax (tablet) 
Rizatriptan benzoate 
Maxalt (tablet, RPD tablet) 
Naratriptan hydrochloride 
Amerge (tablet) 
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Calonal etc  
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Brufen etc 
Diclofenac sodium 
Voltaren etc 
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Naixan (tablet) 
Etodolac 
Hypen/ Osteluc (tablet) 
Celecoxib 
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Mefenamic acid 
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Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 1 of 80 
Amendment 2 
Protocol Title:  A Phase 2, Randomized, Double-blind, Placebo-controlled Study to 
Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention 
 
Amgen Protocol Number AMG 334 20120309 
 
Amendment Date: 
05 June 2017 
 
Rationale: 
This is Amendment 2 for AMG 334 Study 20120309.  Amendment 1 for this protocol was 
not implemented and therefore, the changes captured in this document reflect changes 
made in both Amendment 1 and Amendment 2. 
The primary change to the protocol is to include a Clinical Home Use (CHU) substudy 
during the open-label phase.  The purpose of the CHU substudy is to assess subject’s 
ability to administer a full dose of AMG 334 in home use, using either 2 pre-filled 
70 mg/mL autoinjectors/pens (Als/pens) or 1 pre-filled 140 mg/mL Al/pen. 
In addition, the following were clarified to ensure alignment with study procedures: 
• 
Updated the open-label treatment phase to include AMG 334 dose increase to 
140 mg/mL. 
• 
Update the number of subjects that have received at least 1 dose of AMG 334 to 
date. 
• 
Update pregnancy, lactation, and contraception requirements in alignment with Core 
Risk & Discomforts language. 
• 
To align Section 6 (Treatment Procedures), Section 7 (Study Procedures), and 
Section 10 (Statistical Considerations) with changes made in the pivotal 20120296 
study. 
• 
To align Section 9 (Safety Data Collection, Recording, and Reporting), Section 12.6 
(Publication Policy), and End of Study language with new Amgen protocol template 
language. 
• 
Administration, typographical, and formatting changes were made throughout the 
protocol. 
CONFIDENTIAL 
 
 
 
 

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Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 3 of 80 
Section:  Protocol Synopsis, Clinical Home Use Substudy (During the Open-label 
Treatment Phase [OLTP]) Objectives 
Add: 
Clinical Home Use Substudy (During the Open-label Treatment Phase [OLTP]) 
Objectives: 
• 
Primary Objective:  To assess users’ ability to administer a full dose (140 mg) 
of AMG 334 in home-use, using either 2 pre-filled 70 mg/mL autoinjectors/pens 
(Als/pens) or 1 pre-filled 140 mg/mL AI/pen 
• 
Secondary Objective:  To assess the safety and tolerability of AMG 334 
administered using either 2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 
140 mg/mL AI/pen 
Section:  Protocol Synopsis, Hypothesis 
Add: 
In subjects with episodic migraine, AMG 334 reduces the mean monthly migraine days 
from baseline, compared to placebo.  In the clinical home use (CHU) substudy, it is 
hypothesized that users will be able to administer a full dose of AMG 334 
comparably using 2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 140 mg/mL AI/pen.  
No formal hypotheses will be tested in the CHU substudy. 
Section:  Protocol Synopsis, Clinical Home Use Substudy (During the OLTP) Endpoints 
Add: 
Clinical Home Use Substudy (During the OLTP) Endpoints: 
Primary Endpoint:  Subject-reported outcome of attempted full-dose 
administration at day 29 and day 57. 
Secondary Endpoint:  Subject incidence of adverse events, serious adverse 
events, and adverse device effects 
Section:  Protocol Synopsis, Study Design, Paragraph 2 
Add: 
Approximately 50 subjects will be enrolled in the AMG 334 20120309 CHU 
substudy to assess the subject’s ability to self-administer 140 mg of AMG 334 for 
in-home use.  Subjects will be randomized 1:1 to use either 2 pre-filled 70 mg/mL 
AIs/pens or 1 pre-filled 140 mg/mL AI/pen.  Participation in the substudy is 
optional, and no additional samples will be collected for the substudy. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 4 of 80 
Section:  Protocol Synopsis, Amgen Investigational Product Dosage and Administration, 
Paragraph 1 
Replace: 
Double-blind AMG 334 140 mg, AMG 334 70 mg, AMG 334 28 mg, or placebo will be 
administered during the 24-week double-blind treatment phase (ie, at day 1 and weeks 
4, 8, 12, 16, and 20) and AMG 334 70 mg will be administered during the 52-week 
open-label treatment phase (ie, at weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 
and 72). 
With: 
Double-blind AMG 334 140 mg, AMG 334 70 mg, AMG 334 28 mg, or placebo will be 
administered during the 24-week double-blind treatment phase (ie, at day 1 and weeks 
4, 8, 12, 16, and 20).  During the OLTP, AMG 334 70 mg or 140 mg QM SC will be 
administered, depending on the subject’s visit completion status after institutional 
review board (IRB) approval of Protocol Amendment 2. 
Section:  Protocol Synopsis, Procedures, Paragraph 1 
Replace: 
At the week 24 visit, subjects will be entered into the 52-week open-label treatment 
phase and will begin to receive open-label AMG 334 70 mg QM SC.  A safety follow-up 
visit occurs 16 weeks after the last dose of investigational product.  Subjects will use an 
electronic diary (eDiary) every day throughout the baseline phase, double-blind 
treatment phase and for the first 6 months and last month of the open-label treatment 
phase to report information about their migraine and non-migraine headaches and acute 
headache medication use.  Subjects will have in-clinic study visits monthly after the 
week 4 visit.   
For a full list of study procedures, including the timing of each procedure, please refer to 
Section 7 and the Schedule of Assessments (Table 2). 
With: 
At the week 24 visit, subjects will be entered into the 76-week OLTP and will begin to 
receive open-label AMG 334. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 5 of 80 
After IRB approval of Protocol Amendment 2, the 24-week double-blind treatment 
phase is followed by a 76- week OLTP with the dose determined by the subject’s 
week 48 status: 
(1) Subjects who have already completed the week 48 visit will continue to 
receive open-label AMG 334 70 mg QM SC (OL70) for a total of 76 weeks.  
(2) Subjects who have not yet completed the double-blind treatment phase and 
are not yet in the open-label phase will receive AMG 334 140 mg QM SC 
(OL140) upon entering the open-label phase and continue receiving 
open-label AMG 334 140 mg QM SC for 76 weeks. 
(3) Subjects who have not yet completed the week 48 visit but are in the 
open-label phase receiving AMG 334 70 mg QM SC must increase their 
dose to AMG 334 140 mg QM SC and continue receiving open-label 
AMG 334 140 mg QM SC until the week 100 visit (OL70-140 ) for a total open 
label phase duration of 76 weeks.  The dose increase should be done at the 
first available opportunity, defined as the first visit after IRB approval of 
Protocol Amendment 2.  Refer to Table 3 for assessments to be collected at 
the visit of the dose increase and 12 weeks after the dose increase.  At the 
time of the dose increase, the End of Open-label 70 mg electronic case 
report form (eCRF) page will need to be completed as subjects will be 
transitioning from 70 mg to 140 mg. 
As a result of Protocol Amendment 2, there will be 3 possible dose sequences in 
the open-label phase, depending on completion of week 48 visit as noted above:  
(1) subjects receiving only AMG 334 70 mg QM SC in the open-label phase (OL70),  
(2) subjects receiving only AMG 334 140 mg QM SC in the open-label phase 
(OL140), (3) subjects receiving both AMG 334 70 mg (for up to 24 weeks) and 
140 mg QM SC (OL70-OL140).   
Subjects assigned to receive AMG 334 140 mg QM SC during the open-label phase 
will not have the option to decrease open-label AMG 334 from 140 mg QM to 
70 mg QM.  A safety follow-up visit occurs 16 weeks after the last dose of investigational 
product.  Subjects will use an electronic diary (eDiary) every day throughout the baseline 
phase and double-blind treatment phase and for the first 6 months and between the 
week 72 and week 76 study visits and between the week 96 and week 100/early 
termination (ET) study visits of the OLTP to report information about their migraine 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 6 of 80 
and non-migraine headaches and acute headache medication use.  Subjects will have 
in-clinic study visits monthly after the week 4 visit.   
For a full list of study procedures, including the timing of each procedure, please refer to 
Section 7 and the Schedule of Assessments (Table 2-Table 3, and Table 4 for CHU 
substudy). 
Section: Protocol Synopsis, Statistical Considerations, Paragraph 1 
Replace: 
The final analysis for the study will occur after all subjects have completed safety 
follow-up through week 88 or discontinued from the study. 
With: 
The final analysis for the study will occur after all subjects have completed safety 
follow-up through week 112 or discontinued from the study. 
Section: Protocol Synopsis, Statistical Considerations, Paragraph 3 
Replace: 
For the open-label treatment phase, follow-up time adjusted subject incidence rate of 
treatment-emergent adverse events will be tabulated overall. 
With: 
For the OLTP, exposure-adjusted subject incidence rate of treatment-emergent adverse 
events will be tabulated overall. 
Section: Protocol Synopsis, Statistical Considerations, Paragraph 4 
Add: 
The proportion of subjects who administer a full dose of AMG 334 in home-use 
will be summarized by treatment group at CHU day 29 and day 57.  Subject 
incidence of adverse events, serious adverse events, and adverse device effects 
will be summarized by system organ class and preferred term for subjects 
enrolled in the CHU substudies. 
 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 7 of 80 
Section: Protocol Synopsis, Study Design and Treatment Schema,  
Replace: 
Study Design and Treatment Schema 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 8 of 80 
With: 
Study Design and Treatment Schema for Subjects That Completed Week 48 under Protocol Amendment 2 (OL70 subjects) 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 9 of 80 
Section: Protocol Synopsis, Study Design and Treatment Schema 
Add: 
Study Design and Treatment Schema for Subjects Still in the Double-blind Treatment Phase Protocol Amendment 2 
(OL140 Subjects) 
 
IP = investigational product; QM = monthly; SC = subcutaneous  
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 10 of 80 
Section: Protocol Synopsis, Study Design and Treatment Schema 
Add: 
Study Design and Treatment Schema for Subjects in the Open-label Phase AND Not Yet Completed W48 Under Protocol 
Amendment 2 (OL70-140 Subjects) 
 
IP = investigational product; QM = monthly; SC = subcutaneous 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 11 of 80 
Section:  Study Glossary 
Add: 
AI/Pen 
Autoinjector/pen 
ANCOVA 
Analysis of covariance 
CHU 
Clinical home use 
CMH 
Cochran-Mantel-Haenszel 
eCRF 
Electronic case report form 
IFU 
Instructions for use 
MAR 
Missing at random 
MI 
Multiple imputation 
MNAR 
Missing not at random 
Section:  Study Glossary 
Delete: 
AE 
Adverse event 
Section:  Study Glossary 
Replace: 
End of Trial 
The time when the last subject is assessed or receives an 
intervention for evaluation in the study (ie, when the last 
subject completes the study, which includes the safety 
follow-up visit 16 weeks after the last dose of investigational 
product, or is discontinued from the study) 
Primary Completion 
The time when the last subject is assessed or receives an 
intervention for the purposes of final collection of data for the 
primary analysis (ie, when the last subject completes the 
week 24 assessment or is discontinued from the study)    
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 12 of 80 
Women not of 
childbearing potential 
Any female who:  
• 
Is post-menopausal by history, defined as: 
o Age ≥ 55 years with cessation of menses for 
12 or more months, OR 
o Age < 55 years but no spontaneous menses for 
at least 2 years, OR  
o Age < 55 years and spontaneous menses 
within the past 1 year, but currently 
amenorrheic (eg, spontaneous or secondary to 
hysterectomy), AND with postmenopausal 
gonadotropin levels (luteinizing hormone and 
follicle-stimulating hormone levels > 40 IU/L) or 
postmenopausal estradiol levels (< 5 ng/dL) or 
according to the definition of "postmenopausal 
range" for the laboratory involved. 
OR 
• 
Underwent bilateral oophorectomy OR 
• 
Underwent hysterectomy OR 
• 
Underwent bilateral salpingectomy.   
With: 
End of Study 
The end of study date is defined as the date when the last 
subject across all sites is assessed or receives an intervention 
for evaluation in the study (ie, the last subject last visit), 
following any additional parts in the study (eg, long-term 
follow-up), as applicable. 
Primary Completion 
The primary completion date is defined as the time when 
the last subject is assessed or receives an intervention for the 
final collection of data for the primary endpoint(s), for the 
purpose of conducting the primary analysis, whether the 
study concluded as planned in the protocol or was 
terminated early. 
The primary completion date is the date when the last 
subject has completed the assessments for week 24 or is 
discontinued from the study.    
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 13 of 80 
Women not of 
childbearing potential 
• 
Any female who:  
o Is post-menopausal by history, defined as: 
o Age ≥ 55 years with cessation of menses for 
12 or more months, OR 
o Age < 55 years but no spontaneous menses for 
at least 2 years, OR  
o Age < 55 years and spontaneous menses within 
the past 1 year, but currently amenorrheic (eg, 
spontaneous or secondary to hysterectomy), 
AND with a follicle-stimulating hormone level 
> 40 IU/L or according to the definition of 
"postmenopausal range" for the laboratory 
involved. 
OR 
• 
Underwent bilateral oophorectomy OR 
• 
Underwent hysterectomy OR 
• 
Underwent bilateral salpingectomy.   
Section:  1.3 Exploratory, Bullet 18 
Replace: 
• 
To evaluate the long-term safety, tolerability and maintenance of effect of AMG 334 
after 76 weeks of treatment 
With: 
• 
To evaluate the long-term safety, tolerability and maintenance of effect of AMG 334 
after 100 weeks of treatment  
Section:  1.4 Clinical Home Use Substudy 
Add: 
1.4 
Clinical Home Use Substudy 
1.4.1 Primary 
The primary objective of the clinical home use (CHU) substudy (during the 
open-label treatment phase [OLTP]) is to assess users’ ability to administer a full 
dose (140 mg) of AMG 334 in home-use, using either 2 pre-filled 70 mg/mL 
autoinjectors/pens (Als/pens) or 1 pre-filled 140 mg/mL AI/pen. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 14 of 80 
1.4.2 Secondary 
Secondary objective of the CHU substudy (OLTP):  To assess the safety and 
tolerability of AMG 334 administered using either 2 pre-filled 70 mg/mL Als/pens 
or 1 pre-filled 140 mg/mL AI/pen. 
Section:  2.2 Amgen Investigational Product AMG 334 Background, Paragraph 5 
Replace: 
As of November 2014, approximately 100 subjects (healthy subjects and migraineurs) 
had participated in Phase 1 studies, and 103 subjects with hot flashes associated with 
menopause participated in a Phase 2a study.  Approximately 152 subjects had received 
single or multiple doses of AMG 334 in the Phase 1 and Phase 2a studies.  AMG 334 
has demonstrated a favorable safety and tolerability profile similar to placebo in these 
studies.  Refer to the AMG 334 Investigator’s Brochure for details. 
With: 
As of January 2017, approximately 3623 subjects (2786.43 subject years) have 
received at least 1 dose of AMG 334.  This includes 613 healthy volunteers and 
2917 migraine subjects.  AMG 334 has to date, demonstrated a favorable safety and 
tolerability profile similar to placebo in these studies.  Refer to the AMG 334 
Investigator’s Brochure for details.  
Section:  2.3 Rationale, Paragraph 1 
Replace: 
Migraine prophylaxis is an area of a large unmet medical need, with existing therapies 
having modest efficacy and being poorly tolerated.   
With: 
Migraine prophylaxis is an area of a large unmet medical need, with existing therapies 
having modest efficacy and poor tolerability.   
Section:  2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 1 
Add: 
In the open-label phase, the dose of AMG 334 is being increased to 140 mg in a 
subset of subjects to provide continuous 1-year safety data for subjects receiving 
either AMG 334 70 mg or 140 mg. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 15 of 80 
Section:  2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 3 
Delete: 
AMG 334 140 mg currently is being evaluated in the ongoing chronic migraine study 
(Study 20120295) and efficacy data are being collected. 
Section:  2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 5 
Replace: 
In the global Phase 2 episodic migraine study (Study 20120178), treatment-emergent 
adverse events (AEs) were reported by 165 (51.7%) subjects across all AMG 334 arms, 
and 82 (53.6%) subjects in the placebo arm. 
With: 
In the double blind treatment phase of the global Phase 2 episodic migraine study 
(Study 20120178), treatment-emergent adverse events were reported by 
165 (51.7%) subjects across all AMG 334 arms, and 82 (53.6%) subjects in the placebo 
arm. 
Section:  2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 5 
Replace: 
The safety and tolerability data generated to date support further evaluation of the 70-mg 
dose in the Phase 3 studies. The study 20120178 open-label treatment phase is 
ongoing. 
With: 
The safety and tolerability data generated to date supported further evaluation of the 
70-mg dose in the Phase 3 studies. The study 20120178 OLTP is ongoing and the 
protocol has been amended to increase the open-label dose from 70 mg to 
140 mg. 
Section:  2.3 Rationale, Rationale for AMG 334 Doses, Paragraph 6 and 7 
Replace: 
The 140 mg of AMG 334 is included in the ongoing chronic migraine study 
(Study 20120295). As of 13 November 2014, 165 subjects had been randomized 
3:2:2 to placebo, AMG 334 70 mg, or AMG 334 140 mg, respectively.  Approximately 
47 subjects had been randomized to the 140 mg group. Blinded interim safety review did 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 16 of 80 
not reveal any safety signal. Among all subjects who were randomized in study 
20120295, four (4) subjects had discontinued investigational product, with 
two (2) subjects who discontinued investigational product due to adverse event 
(constipation, gastroesophageal reflux disease). Most commonly reported adverse 
events (≥ 2% in any group) included fatigue, muscle spasms, and nasopharyngitis. Five 
serious adverse events (cholecystectomy, non-cardiac chest pain, pancreatitis, parotitis, 
vomiting) had been reported and all were deemed by the investigator as not related to 
investigational product. 
Overall, the safety data generated to date for both 70 mg and 140 mg of AMG 334 
support further evaluation in Phase 3. 
With: 
AMG 334 140 mg has been evaluated for the prevention of episodic migraine in a 
global Phase 3 study (20120296) with a 24-week double-blind treatment phase.  
The study randomized 955 subjects (AMG 334 70 mg [n = 317], AMG 334 140 mg 
[n = 319], and placebo [n = 319], QM SC) with a history of migraine with or without 
aura for ≥ 12 months and a monthly migraine frequency of ≥ 4 to 
< 15 migraine days.  For the primary endpoint of change in monthly migraine days 
from baseline to the last 3 months (months 4, 5, and 6) of the 24-week 
double-blind treatment phase, the 70 mg and 140 mg doses were significantly 
different from placebo (-3.23 days and -3.67 days vs. -1.83 days, p < 0.001).  Both 
doses produced statistically significant improvements in the secondary outcome 
measures of 50% responder rate and monthly migraine-specific medication 
treatment days.  The results of the other secondary endpoints were consistent 
with those of the primary endpoint.  Across the primary and all secondary 
endpoints, AMG 334 140 mg showed numerically greater efficacy than 70 mg.  At 
the end of the double-blind treatment phase, subjects in each treatment group are 
re-randomized 1:1 in a blinded fashion to AMG 334 70 mg or AMG 334 140 mg for 
the 28-week active treatment phase, which is ongoing. 
During the placebo-controlled double-blind treatment phase of the 
20120296 study, treatment-emergent adverse events were reported in 57.3%, 
55.5%, and 63.0% of subjects in the AMG 334 70 mg, AMG 334 140 mg, and 
placebo groups, respectively, and most were Common Terminology Criteria for 
Adverse Events [CTCAE] grade 1 or 2 (mild to moderate in severity).  Study drug 
discontinuations due to adverse events were reported in 7 subjects (2.2%), 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 17 of 80 
6 subjects (1.9%), and 7 subjects (2.2%) in the AMG 334 70 mg, AMG 334 140 mg, 
and placebo groups, respectively.  The most frequent adverse events occurring in 
≥ 2% of all AMG 334 treated subjects were nasopharyngitis, upper respiratory tract 
infection, sinusitis, constipation, arthralgia, fatigue, and nausea. Serious adverse 
events were reported in 2.5%, 1.9%, and 2.2% of subjects in the AMG 334 70 mg, 
AMG 334 140 mg, and placebo groups, respectively.  No serious adverse event 
occurred in more than 1 subject, except cholelithiasis which was reported by 
2 subjects in the AMG 334 70 mg group (one of whom had clear risk factors).  
Study 20120296 and Study 20120309 are being monitored by the same 
independent DMC. 
In the global 12-week study 20120295, 667 subjects with chronic migraine 
(≥ 15 headache days per month, with ≥ 8 migraine days) were randomized to 
AMG 334 70 mg (n = 191), AMG 334 140 mg (n = 190), or placebo (n = 286), QM SC.  
For the primary endpoint of change in monthly migraine days from baseline to the 
last 4 weeks of the 12-week double-blind treatment phase, the 70 mg and 140 mg 
doses were significantly different from placebo (-6.64 days and -6.63 days vs. 
-4.18 days, p < 0.001).  Treatment-emergent adverse events were reported in 
39.0%, 43.7%, and 46.8% of subjects in the placebo, AMG 334 70 mg, and AMG 334 
140 mg groups, respectively.  No apparent dose-response pattern was observed 
across the most common treatment-emergent adverse events.  The most 
commonly reported adverse events occurring in ≥ 2% of all AMG 334 treated 
subjects were injection site pain, upper respiratory tract infection, nausea, 
nasopharyngitis, constipation, muscle spasms, and migraine.  Serious adverse 
events were reported in 2.5%, 3.2%, and 1.1% of subjects in the placebo, AMG 334 
70 mg, and AMG 334 140 mg groups, respectively.  No individual serious adverse 
event was reported in more than 1 subject in the placebo, AMG 334 70 mg, or 
AMG 334 140 mg groups.  Subjects from 20120295 were eligible to enroll in an 
ongoing 52-week open-label extension study (20130255), in which the original 
dose was 70 mg QM SC, but subsequently the dose was increased to 140 mg QM 
SC.  Of the 609 subjects enrolled, 259 subjects received at least one dose of 
AMG 334 140 mg.  Based on the interim analysis data cut-off of 01 September 2016 
with a mean (SD) duration of exposure to AMG 334 140 mg of 176.4 (70.9) days, 
the reported adverse events were consistent with the known safety profile of 
AMG 334. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 18 of 80 
The global Phase 2 study (20120178) in episodic migraine has an ongoing 
open-label phase of up to 256 weeks.  The original dose was 70 mg but a protocol 
amendment dated 07 April 2016 increased the dose to 140 mg for all subjects.  
Thus 140 mg has been investigated in the double-blind portions of studies 
20120296 and 20120295, as well in open-label or active treatment extension 
phases (studies 20120296, 20130255, 20120178), and no new safety signal has 
been detected.   
Section:  2.3 Rationale, Rationale for AMG 334 Doses, Figure 2 and Table 1 
Delete: 
Figure 2.  Predicted AMG 334 Exposure and Capsaicin-induced Dermal Blood Flow 
(DBF) Inhibition for the Phase 2 Doses Up to 52 Weeks of Dosing in the Japan Phase 2 
Study 
 
Figure legends: 50th (solid lines), 5th and 95th (lower and upper dashed lines) percentiles of predictions.  
Estimated mean maximum inhibition in DBF response from Phase 1 study is approximately 93%.     
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 19 of 80 
Table 1.  Predicted Safety Margins as Ratios of Exposure After SC Dosing of 70 mg 
Q4W Compared to Exposure Following the Highest Tested Safe Dose in Studies 
20101267 and 20101268 
Weight 
(kg)$ 
Predicted Exposure After 
Third Dose of  
70 mg Q4W SC 
Highest Observed Single 
Dose Exposure: 
Predicted Exposure at  
70 mg SC Q4W* 
Observed Multiple Dose 
Exposure at 140 mg SC 
Q4W: Predicted 
Exposure at 70 mg SC 
Q4W# 
Mean AUC0-
28D 
Mean Cmax 
AUC 
Cmax 
AUC 
Cmax 
(µg•day/mL) 
(µg/mL) 
72 
201 
9.4 
2.0 
5.1 
2.4 
2.5 
53 
284 
13 
1.4 
3.7 
1.7 
1.8 
SC = subcutaneous; Q4W = once every 4 weeks; AUC = area under the curve; Cmax = maximum 
concentration. 
$: 72 -kg reference weight for non-Japanese subjects and 53 -kg as typical body weight for a Japanese 
female subject 
*:  Ratios of observed 140 mg IV single dose PK to predicted 70 mg SC Q4W PK after third dose; observed 
mean (%CV) AUC0-28D and Cmax in Study 20101267 at 140 mg IV SD are 403 µg⋅day/mL (12.8) and 
47.8 µg/mL (8.55), N=6, respectively   
#: Ratios of observed 140 mg SC Q4W PK to predicted 70 mg SC Q4W PK after third dose; observed 
preliminary mean (%CV) AUC0-28D and Cmax for 140 mg SC Q4W after third dose in Study 20101268 are 
475 µg⋅day/mL(33.8) and 23.7 µg/mL (33.3), respectively. 
Section:  2.4 Clinical Hypothesis, Paragraph 1 
Add: 
In subjects with episodic migraine, AMG 334 reduces the mean monthly migraine days 
from baseline, compared to placebo.  In the CHU substudy, it is hypothesized that 
users will be able to administer a full dose of AMG 334 comparably using 
2 pre-filled 70 mg/mL AIs/pens or 1 pre-filled 140 mg/mL AI/pen.  No formal 
hypotheses will be tested in the CHU substudy. 
Section:  3.1 Study Design, Paragraph 1 
Replace: 
The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline 
phase, a 24-week double blind treatment phase, a 52-week open-label treatment phase, 
and an 12-week safety follow-up phase (16 weeks after the last dose of investigational 
product). 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 20 of 80 
With: 
The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline 
phase, a 24-week double-blind treatment phase, a 76-week OLTP, and a 12-week 
safety follow-up phase (16 weeks after the last dose of investigational product). 
Section:  3.2 Clinical Home Use Study Design (Optional) (new section) 
Add: 
3.2 
Clinical Home Use Study Design (Optional) 
Approximately 50 subjects will be enrolled in this AMG 334 20120309 CHU 
substudy to assess subjects’ ability to self-administer 140 mg of AMG 334 for 
in-home use.  Subjects will be randomized 1:1 to use either 2 pre-filled 70 mg/mL 
AIs/pens (for a total dose of 140 mg) or 1 pre-filled 140 mg/mL AI/pen.  It is 
hypothesized that users will be able to self-administer a full dose of AMG 334 
comparably using either dosage.  No formal hypotheses will be tested.   
Safety and tolerability of AMG 334 self-administered using two 70 mg/mL AIs/pens 
or one 140 mg/mL AI/pen will also be assessed.  Participation in the substudy is 
optional and no additional samples are collected for the substudy.  Subjects who 
elect to participate in this CHU substudy will be required to provide separate 
informed consent and must meet the eligibility criteria. 
CHU substudy screening (day -28) should occur during or after a subject has 
received at least 1 dose of open-label AMG 334 140 mg.  Subjects should also 
review the AI/pen instructions for use (IFU) at day -28 of the CHU substudy to 
determine if they wish to enroll in the substudy at day 1.  Subjects must have 
received at least 1 dose of AMG 334 140 mg by day 1 of the CHU substudy. 
Day 1 of the CHU substudy should correspond with any 20120309 study visit up 
through week 88.  At day 1, subjects who meet all eligibility criteria will be 
randomized via IVR System to self-administer AMG 334 using either two 70 mg/mL 
AIs/pens or one 140 mg/mL AI/pen (approximately 25 subjects in each arm).   
At CHU substudy day 1, areas that may be injected (upper arm, abdomen, or upper 
thigh) should be examined for any skin abnormalities; adverse events, serious 
adverse events, and adverse device effects will be collected during the CHU 
substudy, and will be assessed on CHU screening, day 1, day 28 (at site), and day 
56 (at site) and on CHU substudy days 29 and 57 (assessed by telephone visit).  
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 21 of 80 
Adverse event, serious adverse event, adverse device effect, concomitant 
medication therapies, vital signs measurement, ECGs, urinalysis, and blood draw 
for serum chemistry and hematology analytes, and anti-AMG 334 antibody assay 
will be performed as described in the main study.  On the CHU substudy day 1 
visit, the site should review the IFU with the subject before administration of IP.  
On day 1 of the substudy, subjects will self-administer IP (two 70 mg/mL AIs/pens 
or one 140 mg/mL AI/pen) under clinical site supervision.   
Subjects will be provided a box containing either two 70 mg/mL AI/pens or one 
dose of 140 mg AI/pen at the CHU substudy day 28 and day 56 visits and will 
self-administer IP individually without supervision at home on substudy days 
29 and 57 of the CHU substudy.  On CHU day 29 and day 57, site staff will call the 
subject at a previously scheduled time and will ask the subject which injection 
site was used, if the subject administered a full, partial, or no dose of AMG 334 
(after explaining that a full dose means that the entire volume of the AI/pen was 
injected) and will document the subject’s response in the eCRF.  If the subject was 
not able to administer a full dose of AMG 334, the site staff will inquire further to 
determine if the subject experienced a device failure or use error that prevented 
the full-dose administration.  Safety will be monitored as adverse events, serious 
adverse events, and adverse device effects.   
Day 85 (clinic visit) is the end of the CHU substudy and sites will inquire about 
adverse events, serious adverse events, and adverse device effects.  At day 85 of 
the CHU substudy, site staff will administer AMG 334 140 mg SC and will continue 
the scheduled procedures and assessments as per the 20120309 protocol.  If a 
subject terminates the CHU substudy early, the subject may receive 
administration of AMG 334 140 mg SC at the site as per the 20120309 protocol and 
will continue 20120309 scheduled procedures and assessments as per the 
20120309 protocol. 
Section:  3.4 Number of Subjects, Paragraph 4 
Add: 
Approximately 50 subjects may participate in the CHU substudy. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 22 of 80 
Section:  3.6.1 Study Duration for Subjects, Paragraph 1 
Replace: 
The planned length of participation in the study for an individual subject is up to 
95 weeks, which includes the following: 
With: 
The planned length of participation in the study for an individual subject is up to 
119 weeks, which includes the following: 
Section:  3.6.1 Study Duration for Subjects, Bullet 4 
Replace: 
• 
52-week open-label treatment phase 
With: 
• 
76-week OLTP 
Section:  3.6.2 End of Study 
Replace: 
Primary Completion:  The time when the last subject is assessed or receives an 
intervention for the purposes of final collection of data for the primary analysis (such as 
when the last subject completes the week 24 assessment or is discontinued from the 
study).  
End of Trial:  The time when the last subject is assessed or receives an intervention for 
evaluation in the study (ie, when the last subject completes the study, which includes the 
safety follow-up visit 16 weeks after the last dose of investigational product, or is 
discontinued from the study). 
With: 
Primary Completion:  The primary completion date is defined as the time when the 
last subject is assessed or receives an intervention for the final collection of data for the 
primary endpoint(s), for the purpose of conducting the primary analysis, whether 
the study concluded as planned in the protocol or was terminated early.  
The primary completion date is the date when the last subject has completed the 
assessments for week 24 or is discontinued from the study).  
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 23 of 80 
If the study concludes prior to the primary completion date originally planned in 
the protocol (ie, early termination of the study), then the primary completion will 
be the date when the last subject is assessed or receives an intervention for 
evaluation in the study (ie, last subject last visit). 
End of Study:  The end of study date is defined as the date when the last subject 
across all sites is assessed or receives an intervention for evaluation in the study 
(ie, last subject last visit), following any additional parts in the study (eg, long-term 
follow-up), as applicable. 
Section:  4.1 Inclusion Criteria, Criterion 109 
Add: 
CHU Substudy: 
• 
Subjects must have provided informed consent for the substudy.  Subjects 
enrolling in the CHU substudy must have received open-label 140 mg 
AMG 334 for at least 1 dose. 
Section:  4.2 Exclusion Criteria, Criterion 221, Bullet 6 Sub-bullet 3 
Replace: 
 
Age < 55 years and spontaneous menses within the past 1 year, but currently 
amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with 
postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating 
hormone levels  
> 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the 
definition of "postmenopausal range" for the laboratory involved. 
With: 
 
Age < 55 years and spontaneous menses within the past 1 year, but currently 
amenorrheic (eg, spontaneous or secondary to hysterectomy), AND with a 
follicle-stimulating hormone level > 40 IU/L or according to the definition of 
"postmenopausal range" for the laboratory involved. 
Section:  4.2 Exclusion Criteria, Criterion 227 
Add: 
CHU Substudy 
227 
Unreliability as a study participant based on the investigator’s (or 
designee’s) knowledge of the subject (eg, unwillingness to adhere to the 
protocol, unwilling to self-inject using an AI/pen after review of the IFU).  
Subjects receiving AMG 334 70 mg in the open-label phase are not eligible. 
CONFIDENTIAL 
 
 
 
 

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Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 26 of 80 
should be separated by no more than approximately 1 minute.  During the open-label 
treatment phase, only 1 SC injection is to be given for each investigational product 
administration (ie, at weeks 24, 28, etc.).  The anatomical sites for administration of 
investigational product are the upper arm, upper thigh, or abdomen.  Please see the 
IPIM for investigational product details. 
With: 
During the double-blind treatment phase, 3 SC injections are to be given for each 
investigational product administration (ie, at day 1 and weeks 4, 8, 12, 16, and 20) to 
maintain the dose-level blinding.  The 3 SC injections should be separated by no more 
than approximately 1 minute.  During the OLTP, 1 SC injection is to be given for 
AMG 334 70 mg and 2 SC injections for AMG 334 140 mg.  If and when 140 mg/mL 
pre-filled syringes become available during the open-label phase, the 140 mg dose 
may be administered by a single 140 mg/mL SC injection. 
After IRB approval of Protocol Amendment 2, after the 24-week double-blind 
treatment phase, there is a 76-week OLTP with the dose determined by the 
subject’s week 48 status: 
(1) Subjects who have already completed the week 48 visit will continue to 
receive open-label AMG 334 70 mg QM SC (OL70) for a total of 76 weeks. 
(2) Subjects who have not yet completed the double-blind treatment phase and 
are not yet in the open-label phase will receive AMG 334 140 mg QM SC 
(OL140) upon entering the open-label phase and continue receiving 
open-label 140 mg QM SC for 76 weeks. 
(3) Subjects who have not yet completed the week 48 visit but are in the 
open-label phase receiving AMG 334 70 mg QM SC must increase their 
dose to AMG 334 140 mg QM SC and continue receiving open-label 
AMG 334 140 mg QM SC until the week 100 visit (OL70-140 ) for a total 
open-label phase duration of 76 weeks.  The dose increase to 140 mg 
should be done at the first available opportunity, defined as the first visit 
after IRB approval of Protocol Amendment 2.  At the time of the dose 
increase, the End of Open-label 70 mg eCRF page will need to be 
completed as subjects will be transitioning from 70 mg to 140 mg. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 27 of 80 
As a result of Protocol Amendment 2, there will be 3 possible dose sequences in 
the open-label phase, depending on completion of week 48 visit as noted above:  
(1) subjects receiving only AMG 334 70 mg QM SC in the open-label phase (OL70), 
(2) subjects receiving only AMG 334 140 mg QM SC in the open-label phase 
(OL140), and (3) subjects receiving both AMG 334 70 mg (for up to 24 weeks) and 
140 mg QM SC (OL70-140).  Subjects assigned to receive AMG 334 140 mg QM SC 
during the open-label phase will not have the option to decrease open-label 
AMG 334 from 140 mg QM to 70 mg QM. 
The anatomical sites for administration of investigational product are the upper arm, 
upper thigh, or abdomen.  Please see the IPIM for investigational product details. 
Section:  6.2.1.1 Dosage, Administration, and Schedule, Paragraph 7 
Add: 
During the CHU substudy, the subject will self-administer IP (1 or 2 injections 
using AI/pen) under site supervision on day 1.  On day 28 and day 56 during the 
CHU substudy, the site will provide IP to the subject to self-administer (1 or 
2 injections using AI/pen) on the next day.  The anatomical sites for 
self-administration are the upper thigh or abdomen.  The upper arm should only 
be used if administered by a care-giver.  During the CHU substudy the injection 
site location should be the same for all injections but do not use the same spot on 
the injection site you used for a previous injection.  For further details regarding 
self-administration procedures, the IFU should be consulted. 
Section:  6.2.1.1 Dosage, Administration, and Schedule, Paragraph 11 
Add: 
If a subject is enrolled in the CHU substudy, the box number provided to the 
subject and information obtained at telephone visits should be recorded by the 
site on each subject’s CRF, as described in Section 7.2.25.  
Section:  6.2.1.2 Dosage Adjustments, Delays, Rules for Withholding or Restarting, 
Permanent Discontinuation, Paragraph 5 
Replace: 
Subjects who permanently discontinue investigational product during the open-label 
treatment phase are to complete the study procedures for the week 76/early termination 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 28 of 80 
(ET) visit and the safety follow-up visit 16 weeks after the last dose of investigational 
product. 
With: 
Subjects who permanently discontinue investigational product during the OLTP are to 
complete the study procedures for the week 100/early termination (ET) visit and the 
safety follow-up visit 16 weeks after the last dose of investigational product. 
Section:  6.3 Hepatoxicity Stopping and Rechallenge Rules 
Replace: 
6.3 
Hepatoxicity Stopping and Rechallenge Rules 
Subjects with abnormal hepatic laboratory values (ie, alkaline phosphatase [ALP], 
aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin [TBL]) 
and/or international normalized ratio [INR] and/or signs/symptoms of hepatitis (as 
described below) may meet the criteria for withholding or permanent discontinuation of 
Amgen investigational product (as specified in the Guidance for Industry Drug-Induced 
Liver Injury:  Premarketing Clinical Evaluation, July 2009). 
6.3.1 
Criteria for Permanent Discontinuation of Amgen Investigational Product 
Due to Potential Hepatotoxicity 
Amgen investigational product will be discontinued permanently and the subject should 
be followed according to the recommendations in Appendix A (Additional Safety 
Assessment Information) for possible drug-induced liver injury (DILI), if ALL of the 
criteria below are met:  
• 
TBL > 2x upper limit of normal (ULN) or INR > 1.5 
• 
AND increased AST or ALT from the relevant baseline value as specified below:  
Baseline AST or ALT value 
AST or ALT elevation 
< ULN 
> 3x ULN 
• 
AND no other cause for the combination of the above laboratory abnormalities is 
immediately apparent; important alternative causes for elevated AST/ALT and/or 
TBL values include, but are not limited to: 
− 
Hepatobiliary tract disease 
− 
Viral hepatitis (eg, Hepatitis A/B/C/D/E, Epstein-Barr Virus, cytomegalovirus, 
Herpes Simplex Virus, Varicella, toxoplasmosis, and Parvovirus) 
− 
Right sided heart failure, hypotension, or any cause of hypoxia to the liver 
causing ischemia   
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 29 of 80 
− 
Exposure to hepatotoxic agents/drugs or hepatotoxins, including herbal and 
dietary supplements, plants, and mushrooms   
− 
Heritable disorders causing impaired glucuronidation (eg, Gilbert’s Syndrome, 
Crigler-Najjar syndrome) and drugs that inhibit bilirubin glucuronidation (eg, 
indinavir, atazanavir) 
− 
Alpha-one antitrypsin deficiency 
− 
Alcoholic hepatitis 
− 
Autoimmune hepatitis  
− 
Wilson’s disease and hemochromatosis 
− 
Nonalcoholic Fatty Liver Disease including Nonalcoholic Steatohepatitis (NASH)  
− 
Non-hepatic causes (eg, rhabdomylosis, hemolysis) 
6.3.2 
Criteria for Conditional Withholding of Amgen Investigational Product Due 
to Potential Hepatotoxicity 
For subjects who do not meet the criteria for permanent discontinuation of Amgen 
investigational product outlined above and have no underlying liver disease, and 
eligibility criteria requiring normal transaminases and TBL at baseline or subjects with 
underlying liver disease and baseline abnormal transaminases, the following rules are 
recommended for withholding of Amgen investigational product:  
• 
Elevation of either AST or ALT according to the following schedule: 
Baseline AST or ALT value 
AST or ALT elevation 
Any 
> 8x ULN at any time 
Any 
> 5x ULN but < 8x ULN for ≥ 2 weeks 
Any 
> 5x ULN but < 8x ULN and unable to adhere to enhanced 
monitoring schedule 
Any 
> 3x ULN with clinical signs or symptoms that are 
consistent with hepatitis (such as right upper quadrant 
pain/tenderness, fever, nausea, vomiting, jaundice) 
• 
OR: TBL > 3x ULN at any time 
• 
OR: ALP > 8x ULN at any time 
Amgen investigational product should be withheld pending investigation into alternative 
causes of DILI.  If investigational product is withheld, the subject is to be followed 
according to recommendations in Appendix A for possible DILI.  Rechallenge may be 
considered if an alternative cause for impaired liver tests (ALT, AST, ALP) and/or 
elevated TBL, is discovered and the laboratory abnormalities resolve to normal or 
baseline (Section 6.3.3). 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 30 of 80 
6.3.3 
Criteria for Rechallenge of Amgen Investigational Product After Potential 
Hepatotoxicity 
The decision to rechallenge the subject should be discussed and agreed upon 
unanimously by the subject, investigator, and Amgen. 
If signs or symptoms recur with rechallenge, then Amgen investigational product should 
be permanently discontinued.  Subjects who clearly meet the criteria for permanent 
discontinuation (as described in Section 6.3.1) should never be rechallenged. 
With: 
6.3 
Hepatotoxicity Stopping Rules 
Refer to Appendix A for details regarding drug-induced liver injury (DILI) 
guidelines, as specified in the Guidance for Industry Drug-Induced Liver Injury:  
Premarketing Clinical Evaluation, July 2009. 
Section:  6.4 Concomitant Therapy, Paragraph 4 
Add: 
During the initial screening phase, the subject and investigator are to agree on the acute 
headache medications shown below (Table 1) and the appropriate dose(s) that the 
subject may take on an as-needed basis (PRN) throughout the study. 
Section:  6.4 Concomitant Therapy, Table Header 
Add: 
Table 1.  List of Acute Headache Medications 
Section:  6.5 Medical Devices, Paragraph 3 
Add: 
In the CHU substudy, the AMG 334 SureClick AI/pen is a single-use, disposable, 
handheld mechanical injection device that administers a fixed-dose of AMG 334 
into SC tissue.  The AMG 334 AI/pen uses the same components as the 
commercially available Repatha SureClick autoinjector. 
Subjects participating in the CHU substudy will return the AIs/pens to the clinic 
for reconciliation and disposal by the site staff using a plastic box provided by 
Amgen to the clinical sites.  Medical devices that are not considered test articles 
may be used in the conduct of the study as part of standard of care (except for 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 31 of 80 
AI/pen).  The investigator will be responsible for obtaining supplies of these 
devices. 
Detailed information regarding the medical devices will be provided separately in 
the IPIM. 
Section:  6.6 Product Complaints, Paragraph 1 
Replace: 
A product complaint is any written, electronic or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or 
performance of any product(s) or device(s) after it is released to the clinic by Amgen or 
by distributors, and partners with whom Amgen manufactures the material.  This 
includes any products or devices provisioned and/or repackaged/modified by Amgen. 
With: 
A product complaint is any written, electronic or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or 
performance of any product(s) or device(s) after it is released for distribution to market 
or clinic by either Amgen or by distributors, and partners with whom Amgen 
manufactures the material.  This includes any products, devices, combination 
product(s) provisioned and/or repackaged/modified by Amgen.  Drug(s) or device(s) 
includes investigational product. 
Section:  6.7 Excluded Therapies Prior to the Start of the Baseline Phase and 
Throughout the Study, Number 5 
Replace: 
5. 
Investigational medications, devices, and procedures are excluded throughout 
the study.  Subjects also must not have used investigational medications, devices or 
procedures for at least 90 days prior to screening (refer to Exclusion Criterion 222). 
With: 
5 
Investigational medications and devices are excluded throughout the study.  
Subjects also must not have used investigational medications, devices or procedures for 
at least 90 days prior to screening (refer to Exclusion Criterion 222). 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 32 of 80 
Section:  7 Study Procedures, Paragraph 1 
Add: 
Refer to the Schedule of Assessments (Table 2-Table 4) for an outline of the procedures 
required at each study visit. 
Section:  7 Study Procedures, Paragraph 3, Bullet 3 
Replace: 
• 
Each study visit during the 52-week open-label treatment phase has a window of 
± 4 consecutive calendar days. 
With: 
• 
Each study visit during the 76-week OLTP has a window of ± 4 consecutive calendar 
days. 
Section:  7 Study Procedures, Paragraph 4 
Add: 
Refer to the Schedule of Assessments (Table 4) for an outline of the procedures 
required at each study visit in the CHU substudy.
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 33 of 80 
Section:  7.1 Schedule of Assessments, Table 2 
Add: 
Procedures 
Screening Phase  
(up to 7 wks) 
Double-blind Treatment Phase (24 wks) 1 
Initial 
Screening 
(up to  
3 wks) 2 
Baseline 
Phase  
(4 wks) 1 
D 1 
(post-
rand.) 
Wk 4 
Wk 8 
Wk 12 
Wk 16 
Wk 20 
Wk 24 / 
ET 3 
Wk 
-4 
D 1 
(pre-
rand.) 
Medical and Medication History 
X 
 
 
 
 
 
 
X 
 
 
Employment Status 15 
 
 
 
X 
 
 
X 
 
 
X 
Adverse Event/Serious Adverse Event 
Collection/Recording/Reporting 16 
X (SAEs only) 
X 
X 
X 
X 
X 
X 
X 
Section: 7.1 Schedule of Assessments, Table 2, Footnotes 
Replace: 
Footnotes defined on last page of the second table 
With: 
Footnotes defined on last page of Table 4. 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 34 of 80 
Section:  7.1 Schedule of Assessments, Table 3 
Replace: 
Procedures 
Open-label Treatment Phase (OLTP) (52 wks) 1 
Safety 
F/U 1 
Wk 
24 
(cont) 
Wk 
28 
Wk 32 
Wk 
36 
Wk 
40 
Wk 
44 
Wk 
48 
Wk 
52 
Wk 
56 
Wk 
60 
Wk 64 
Wk 
68 
Wk 72 
Wk 
76 
/ET 
16 Wks 
After Last 
Dose of 
IP 
Study Visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Calls to IVR/IWR System 2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Entry into the OLTP 6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PE 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Body Weight Measurement 7 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
X 
Vital Signs 8 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
UDS 
 
Testing as needed throughout study based on investigator’s clinical suspicion 
Pregnancy Testing- Serum 9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Pregnancy Testing- Urine 9 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Chemistry, Hematology 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
ECG 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
X 
 
PK Sampling 10 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
Anti-AMG 334 Antibodies; 
Serum  
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X 
X 
COAs 14 
X (Daily) 
 
 
 
 
X (Daily) 
 
Subject Brings eDiary to Site 
for Use during Study Visit 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
X 
 
Migraine Symptom  
Interference Items 14 
X (Daily) 
 
 
 
 
X (Daily) 
 
Migraine Physical Function 
Impact Stand-alone Item 14 
X (Daily) 
 
 
 
 
X (Daily) 
 
HIT-6 14  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
C-SSRS 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
Recording 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IP Administration 15 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Adverse Event Recording 16 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Product Complaints 
Recording 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 35 of 80 
With: 
Procedures 
Open-label Treatment Phase (OLTP) (76 wks) 1 
Safety 
F/U 1 
Wk 24 
(cont) 
Wk 
28 
Wk 
32 
Wk 
36 
Wk
40 Wk 44 Wk 48 Wk 52 Wk 56 Wk 60 Wk 64 Wk 68 Wk 72 
Wk 
76 
Wk
80 
Wk 
84 
Wk 
88 
Wk 
92 
Wk 
96 
Wk 100 
/ET3 
Dose 
increase to 
140 mg 
visit18 
12 wk 
post 
increase
18 
16 Wks 
After Last 
Dose of IP
Study Visit 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
Calls to IVR/IWR 
System 2 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
Entry into the OLTP 6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PE 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
X 
X 
X 
X 
Body Weight 
Measurement 7 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X  
 
 
 
 
X 
X 
 
X 
Vital Signs 8 
 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
UDS 
Testing as needed throughout study based on investigator’s clinical suspicion 
Pregnancy Testing- 
Serum 9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Pregnancy Testing- 
Urine 9 
 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
 
Chemistry, 
Hematology 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X  
 
 
 
 
X 
X 
X 
X 
ECG 
 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
X  
 
X 
 
 
X 
X 
X 
 
PK Sampling 10 
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X  
 
 
 
 
X 
X 
X 
X 
Anti-AMG 334 
Antibodies; Serum  
 
X 
 
X 
 
 
 
X 
 
 
 
 
 
X  
 
 
 
 
X 
X 
X 
X 
Page 1 of 2 
Footnotes defined on last page of Table 4. 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 36 of 80 
Procedures 
Open-label Treatment Phase (OLTP) (76 wks) 1 
Safety 
F/U 1 
Wk 24 
(cont) 
Wk 
28 
Wk 
32 
Wk 
36 
Wk
40 Wk 44 Wk 48 Wk 52 Wk 56 Wk 60 Wk 64 Wk 68 Wk 72 
Wk 
76 
Wk
80 
Wk 
84 
Wk 
88 
Wk 
92 
Wk 
96 
Wk 100 
/ET3 
Dose 
increase to 
140 mg 
visit18 
12 wk 
post 
increase
18 
16 Wks 
After Last 
Dose of IP
COAs 14 
X (Daily) 
 
 
 
 
X 
(Daily) 
 
 
 
 
X (Daily) 
 
 
 
Subject Brings eDiary 
to Site for Use during 
Study Visit 
 
X X 
X 
X 
X 
X 
X 
 
 
 
 
 
X  
 
 
 
 
X 
 
 
 
Migraine Symptom  
Interference Items 14 
X (Daily) 
 
 
 
 
X 
(Daily) 
 
 
 
 
X (Daily) 
 
 
 
Migraine Physical 
Function Impact 
Stand-alone Item 14 
X (Daily) 
 
 
 
 
X 
(Daily) 
 
 
 
 
X (Daily) 
 
 
 
HIT-6 14  
 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
 
C-SSRS 
 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
Employment Status 
17 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
Concomitant 
Medications Recording 
 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
IP Administration 15 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
 
X 
X 
 
Adverse 
Event/Adverse 
Device 
Effects/Serious 
Adverse Event 
Collection 
/Recording/Reporting 
16 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
Product Complaints 
Recording 
X 
X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X 
X 
X 
X 
 
X 
X 
 
Page 2 of 2 
Footnotes defined on last page of Table 4. 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 37 of 80 
Section:  7.1 Schedule of Assessments, Table 4 
Add: 
Table 4.  Clinical Home Use Substudy Assessments  
 
Screening19 
Day 120 
Day 28 visit 
Day 29 
Telephone 
visit 
Day 56 visit 
Day 57 
Telephone 
visit 
Day 85 visit21/ 
ET22 
Informed Consent  
X 
 
 
 
 
 
 
Randomization to AMG 334 70 mg/ml 
AI/pen x2 or AMG 334 140 mg/ml 
AI/pen IP self-administration arm 
 
X 
 
 
 
 
 
AI/pen Instruction23 
X 
X 
 
 
 
 
 
Examination of areas for injection 
 
X 
 
 
 
 
 
Self-administration IP on-site 
 
X 
 
 
 
 
 
Self-administration IP at non-clinic 
setting 
 
 
 
X 
 
X 
 
Study coordinator IP dispense 
 
 
X 
 
X 
 
 
Study coordinator IP reconcile 
 
X 
 
 
X 
 
X 
Inquiry re: administration of IP 
 
 
 
X 
 
X 
 
Review for Adverse Device Effects 
X 
X 
X 
X 
X 
X 
X 
Review for adverse events/serious 
adverse events 
X 
X 
X 
X 
X 
X 
X 
Product Complaints Recording (if 
applicable) 
 
X 
X 
X 
X 
X 
X 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 38 of 80 
Section:  7.1 Schedule of Assessments, Table 4 Footnotes (moved from Table 3 to Table 4) 
Replace: 
AE = adverse event; BDI-II = Beck Depression Inventory-II; CGRP = Calcitonin gene-related peptide; COAs = Clinical Outcomes Assessments; cont = continued; C 
SSRS = Columbia-Suicide Severity Rating Scale; D = day; DBTP = Double-blind Treatment Phase; ECG = electrocardiogram; eDiary = electronic diary; EOS = end 
of study; EOT = end of treatment; ET = early termination; F/U = follow-up; HIT-6 = Headache Impact Test; IP = investigational product; IVR = interactive voice 
response; IWR = interactive web response; M = month (end of month x); OLTP = open-label treatment phase; PE = physical exam; per. = period; PK = 
pharmacokinetics; QM = monthly; rand. = randomized / randomization; SAE = serious adverse event; SC = subcutaneous; UDS = urine drug screen; Wk = week (end 
of week x); Wkly = weekly  
1  Each study visit during the double-blind treatment phase and safety follow-up has a window of ± 3 consecutive calendar days.  The day 1 visit (randomization day) 
has a window of 0, +7 consecutive calendar days; the day 1 visit must occur 28 to 35 days after the week -4 visit date.  Each study visit during the open-label 
treatment phase has a window of ± 4 consecutive calendar days.  All study visit target dates are to be calculated from the day 1 visit date.  All study procedures for a 
given study visit are to be completed on the same day. 
2   
Sites to access the Interactive Voice Response (IVR) / Interactive Web Response (IWR) System for the following: to enter the subject into the initial screening  
 phase, to randomize an eligible subject, to obtain the investigational product assignment, to enter the subject into the open-label treatment phase, to register the end 
of investigational product, and to register study early termination or completion.  Subject data will be collected in the IVR/IWR System including, but not limited to 
reason for screen fail (if applicable).  
   Sites to access the IVR/IWR System to obtain the investigational product assignment at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72.  
The IVR/IWR System will automatically assign investigational product when a subject is randomized at day 1 and when a subject is entered into the open-label 
treatment phase at week 24.  Investigational product is dosed QM, SC. 
3 A subject who discontinues the study during the double-blind treatment phase will complete the week 24/early termination (ET) visit.  A subject who discontinues 
open-label investigational product or the study during the open-label treatment phase will complete the week 76/early termination (ET) visit.  Subjects also will 
complete the safety follow-up visit 16 weeks after the last dose of investigational product.    
4 Entry into the baseline phase must occur only after completion of initial screening phase procedures 
6  Enrollment (ie, randomization) into the double-blind treatment phase using the IVR/IWR System must occur only after completion of all baseline phase procedures 
  and prior to the first dose of double-blind investigational product (randomization and administration of the first dose of investigational product should occur on day 1) 
6   
Entry into the open-label treatment phase using the IVR/IWR System must occur only after completion of all double-blind treatment phase procedures and 
prior to 
 the first dose of open-label AMG 334 70 mg QM SC 
7  Height and weight, measured without shoes.  Height to be collected at the initial screening phase visit only.  
8  Systolic/diastolic blood pressure, heart rate and body temperature.  Blood pressure to be obtained after the subject has been in a semi-recumbent position (partial 
semi- Fowler’s position) or supine position in a rested and calm state for at least 5 minutes.  At least 2 measurements (separated by at least 5 min) should be made 
and the average recorded.  The position selected for a subject should be used for all blood pressure measurements throughout the study. 
9 Pregnancy testing for women of childbearing potential (WOCBP) 
10 Samples for PK assessment will be serum   
11 PK samples collected at a study visit during which investigational product will be administered should be collected before dosing with investigational product (trough)   
12 Only subjects participating in the optional PK substudy (must have provided informed consent for the PK substudy) will have blood samples collected on 
 day 8 and day 64.  The PK substudy sampling window is ± 3 consecutive calendar days.     
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 39 of 80 
13 For subjects who provided informed consent for the pharmacogenetic studies, DNA will be obtained from the cell pellet collected in the plasma tube used for the 
biomarker development sample.  Therefore, additional sampling is not required.  
14 Clinical Outcomes Assessments (COAs) and Patient-reported Outcomes (PROs) to be collected by subjects using eDiaries. The HIT-6 is to be completed during 
applicable study visits before invasive procedures (eg, blood draws) and investigational product administration.  
15 Site study staff to administer investigational product to subjects on day 1 (only after randomization and completion of all day 1 procedures) and at weeks 4, 8, 12, 16, 
20, 24 (only after entering the open-label treatment phase and completion of all week 24 procedures), 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72.  
Investigational product administration should occur after any trough PK sampling.  Sites are to record the time of investigational product administration.  Following the 
first 3 doses of investigational product in the double-blind treatment phase (ie, day 1, week 4, week 8), subjects are to remain in the clinic for approximately 1 hour for 
observation. 
16  
SAEs are to be collected after signing of the informed consent through end of study (16 weeks after the last dose of investigational product).  Non-serious AEs 
are to be collected after the first dose of investigational product through end of study (16 weeks after the last dose of investigational product). 
With: 
ADE = adverse device effect; AE = adverse event; AI = autoinjector; BDI-II = Beck Depression Inventory-II; CGRP = Calcitonin gene-related peptide; CHU = clinical 
home use; COAs = Clinical Outcomes Assessments; cont = continued; C-SSRS = Columbia-Suicide Severity Rating Scale; D = day; DBTP = Double-blind 
Treatment Phase; ECG = electrocardiogram; eDiary = electronic diary; EOS = end of study; EOT = end of treatment; ET = early termination; F/U = follow-up; HIT-6 = 
Headache Impact Test; IP = investigational product; IVR = interactive voice response; IWR = interactive web response; M = month (end of month x); OLTP = open-
label treatment phase; PE = physical exam; per. = period; PK = pharmacokinetics; PROs = Patient-reported Outcomes; QM = monthly; rand. = randomized / 
randomization; SAE = serious adverse event; SC = subcutaneous; UDS = urine drug screen; Wk = week (end of week x); Wkly = weekly; WOCBP = women of 
childbearing potential 
1  Each study visit during the double-blind treatment phase and safety follow-up has a window of ± 3 consecutive calendar days.  The day 1 visit (randomization day) 
has a window of 0, +7 consecutive calendar days; the day 1 visit must occur 28 to 35 days after the week -4 visit date.  Each study visit during the open-label 
treatment phase has a window of ± 4 consecutive calendar days.  All study visit target dates are to be calculated from the day 1 visit date.  All study procedures for a 
given study visit are to be completed on the same day. 
2   Sites to access the Interactive Voice Response (IVR) / Interactive Web Response (IWR) System for the following: to enter the subject into the initial screening phase, 
to randomize an eligible subject, to obtain the investigational product assignment, to enter the subject into the open-label treatment phase, to register the end of 
investigational product, and to register study early termination or completion.  Subject data will be collected in the IVR/IWR System including, but not limited to reason 
for screen fail (if applicable).  
   Sites to access the IVR/IWR System to obtain the investigational product assignment at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72.  
The IVR/IWR System will automatically assign investigational product when a subject is randomized at day 1 and when a subject is entered into the open-label 
treatment phase at week 24.  Investigational product is dosed QM, SC. 
3 A subject who discontinues the study during the double-blind treatment phase will complete the week 24/early termination (ET) visit.  A subject who discontinues 
open-label investigational product or the study during the open-label treatment phase will complete the week 100/early termination (ET) visit.  Subjects also will 
complete the safety follow-up visit 16 weeks after the last dose of investigational product.    
4 Entry into the baseline phase must occur only after completion of initial screening phase procedures 
5Enrollment (ie, randomization) into the double-blind treatment phase using the IVR/IWR System must occur only after completion of all baseline phase procedures and 
prior to the first dose of double-blind investigational product (randomization and administration of the first dose of investigational product should occur on day 1) 
6   Entry into the open-label treatment phase using the IVR/IWR System must occur only after completion of all double-blind treatment phase procedures and prior to the 
first dose of open-label AMG 334  
7  Height and weight, measured without shoes.  Height to be collected at the initial screening phase visit only.  
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 40 of 80 
8  Systolic/diastolic blood pressure, heart rate and body temperature.  Blood pressure to be obtained after the subject has been in a semi-recumbent position (partial 
semi- Fowler’s position) or supine position in a rested and calm state for at least 5 minutes.  At least 2 measurements (separated by at least 5 min) should be made 
and the average recorded.  The position selected for a subject should be used for all blood pressure measurements throughout the study. 
9 Pregnancy testing for women of childbearing potential (WOCBP)  Note:  Additional on treatment pregnancy testing may be performed at the investigator’s 
discretion or per local laws and regulation. 
10 Samples for PK assessment will be serum.   
11 PK samples collected at a study visit during which investigational product will be administered should be collected before dosing with investigational product (trough)   
12 Only subjects participating in the optional PK substudy (must have provided informed consent for the PK substudy) will have blood samples collected on 
 day 8 and day 64.  The PK substudy sampling window is ± 3 consecutive calendar days.     
13 For subjects who provided informed consent for the pharmacogenetic studies, DNA will be obtained from the cell pellet collected in the plasma tube used for the 
biomarker development sample.  Therefore, additional sampling is not required.  
14 Clinical Outcomes Assessments (COAs) and Patient-reported Outcomes (PROs) to be collected by subjects using eDiaries. The HIT-6 is to be completed during 
applicable study visits before invasive procedures (eg, blood draws) and investigational product administration.  
15 Site study staff to administer investigational product to subjects on day 1 (only after randomization and completion of all day 1 procedures) and at weeks 4, 8, 12, 16, 
20, 24 (only after entering the open-label treatment phase and completion of all week 24 procedures), 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 
92, and 96.  Investigational product administration should occur after any trough PK sampling.  Sites are to record the time of investigational product administration.  
Following the first 3 doses of investigational product in the double-blind treatment phase (ie, day 1, week 4, week 8), subjects are to remain in the clinic for 
approximately 1 hour for observation. 
16 Serious adverse events are to be collected after signing of the informed consent through end of study (16 weeks after the last dose of investigational product).  
Non-serious adverse events and adverse device effects (for OLTP only) are to be collected after the first dose of investigational product through end of study (16 
weeks after the last dose of investigational product). 
17 Current employment status will be collected at D1 (pre-rand.), week 12, week 24, and during the open label phase; the status should be collected 
retrospectively if needed. 
18Visit for Dose Increase to 140 mg and 12Wk Post Increase to 140 mg apply only to subjects in the open-label phase who have not completed W48 after 
IRB approval of Protocol Amendment 2. 
19 Screening must occur 4 weeks prior to the planned start of the CHU substudy (day 1).  IVR System will be adjusted to accommodate CHU substudy 
screening and randomization information as required. 
20 Day 1 of the CHU substudy may occur at any visit as long as subject has received at least 1 open-label dose of AMG 334 140 mg in the 20120309 main 
study. 
21 At day 85 of the CHU substudy, subject will receive AMG 334 140 mg SC administered by site staff using PFS formulation and will continue scheduled 
procedures and assessments as per 20120309 main study. 
22 ET:  If a subject early terminates the CHU substudy, he/she may receive administration of AMG 334 140 mg SC at the site as per 20120309 main study and 
will continue 20120309 scheduled procedures and assessments as per 20120309 main study. 
23Study coordinator will review AI/pen training materials (Instructions for Use) with subject at screening and will review AI/pen training materials at day 1 of 
the CHU substudy. 
 
CONFIDENTIAL 
 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 41 of 80 
Section:  7.2.3 Medical and Medication History, Paragraph 1 
Add: 
A review of medical and medication history will be performed at initial screening to 
confirm subject eligibility and at week 16. 
Section:  7.2.13 Clinical Outcomes Assessments (COAs) and Electronic Diaries 
(eDiaries), Paragraph 4 
Replace: 
The subject will be instructed to interact with the eDiary every day during the baseline 
phase and between the day 1 and week 52 study visits and between the week 72 and 
week 76/early termination (ET) study visits, and to bring the eDiary to every study visit 
during these periods.  At the day 1 study visit the investigator will use the subject’s 
eDiary to review all data entered during the baseline phase and confirm the relevant 
inclusion and exclusion criteria. 
With: 
The subject will be instructed to interact with the eDiary every day during the baseline 
phase and between the day 1 and week 52 study visits, between the week 72 and 
week 76/ study visits, between the week 96 and week 100/early termination (ET) 
study visits, and to bring the eDiary to every study visit during these periods.  At the 
day 1 study visit the investigator will use the subject’s eDiary to review all data entered 
during the baseline phase and confirm the relevant inclusion and exclusion criteria.  
During these periods the subject will bring the eDiary to every study visit. 
Section:  7.2.17 Adverse Event, Serious Adverse Event, Adverse Device Effect 
Collection/Recording/Reporting 
Add: 
7.2.17 Adverse Event, Serious Adverse Event, Adverse Device Effect 
Collection/Recording/Reporting 
Adverse event, serious adverse event, and adverse device effect information should 
be collected throughout the study and recorded at each study visit.  Refer to Section 9 
for details.   
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 42 of 80 
Section:  7.2.19 Laboratory Assessments, Paragraph 3 
Add: 
Any sample collected according to the Schedule of Assessments (Table 2-Table 4) may 
be analyzed for any of the tests outlined in the protocol and for any tests necessary to 
ensure subject safety. 
Section:  7.2.19 Laboratory Assessments, Paragraph 4 
Add: 
See Table 5 for Analyte Listing (all run by central laboratory, unless otherwise noted as 
“Amgen/designee” or “local” laboratory.  Please refer to the central laboratory manual for 
the complete listing of analytes run by the central laboratory): 
Section:  7.2.19 Laboratory Assessments, Table 5 Header 
Add: 
Table 5.  Analyte Listing 
Section:  7.2.20 Initial Screening Phase, Bullet 13 
Add: 
Serious adverse event collection/recording/reporting (Note:  Serious adverse events 
are to be collected after signing of the informed consent through 16 weeks after the last 
dose of investigational product.) 
Section:  7.2.21.1 Week -4 Visit, Bullet 7 
Add: 
Serious adverse event collection/recording/reporting 
Section:  7.2.22 Day 1 Visit (Prior to Randomization), Bullet 6 
Add: 
• 
Employment status 
Section:  7.2.22 Day 1 Visit (Prior to Randomization), Bullet 8 
Add: 
• 
Serious adverse event collection/recording/reporting 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 43 of 80 
Section:  7.2.23 Day 1 (After Randomization) and the Double-blind Treatment Phase, 
Bullet 3 
Add: 
• 
Medical and Medication History 
Section:  7.2.23 Day 1 (After Randomization) and the Double-blind Treatment Phase, 
Bullet 17 
Add: 
• 
Employment status (weeks 12 and 24/end of double-blind treatment phase) 
Section:  7.2.23 Day 1 (After Randomization) and the Double-blind Treatment Phase, 
Bullet 20 
Add: 
• 
Serious and non-serious adverse event collection/recording/reporting.  (Note: 
Serious adverse events are to be collected after signing of the informed consent 
through 16 weeks after the last dose of investigational product.  Non-serious adverse 
events are to be collected after the first dose of investigational product through 
16 weeks after the last dose of investigational product.)  
Section:  7.2.24 Open-label Treatment Phase, Bullet 15 
Add: 
• 
Employment status 
Section:  7.2.24 Open-label Treatment Phase, Bullets 17, 18, 19, and 20 
Add: 
• 
Administration of open-label AMG 334 70 mg QM SC or 140 mg QM SC.  The first 
dose of open-label investigational product is to be administered only after completion 
of all week 24 procedures.  In general, administration of investigational product 
should be the last procedure performed at each study visit. 
• 
After IRB approval of Protocol Amendment 2, the 24-week double-blind 
treatment phase is followed by a 76-week OLTP with dose determined by the 
subject’s week 48 status: 
• 
(1)  Subjects who have already completed the week 48 visit will continue to 
receive AMG 334 70 mg QM SC (OL70) for a total of 76 weeks, following the 
open label assessments in Table 3. 
• 
(2)  Subjects who have not yet completed the double-blind treatment phase 
and are not yet in the open-label phase will receive AMG 334 140 mg QM SC 
(OL140) upon entering the open-label phase and continue receiving 
open-label AMG 334 140 mg QM SC for 76 weeks. 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 44 of 80 
• 
(3)  Subjects who have not yet completed the week 48 visit but are in the 
open-label phase receiving AMG 334 70 mg QM SC must increase their 
dose to AMG 334 140 mg QM SC and continue receiving open-label 
AMG 334 140 mg QM SC until the week 100 visit (OL70-140) for a total open 
label phase duration of 76 weeks.  The dose increase should be done at the 
first available opportunity, defined as the first visit after IRB approval of 
Protocol Amendment 2.  Refer to Table 3 for assessments to be collected at 
the visit of the dose increase and 12 weeks after the dose increase.  At the 
time of the dose increase, the End of Open Label 70 mg eCRF page will 
need to be completed as subjects will be transitioning from 70 mg to 
140 mg. 
• 
Serious and non-serious adverse event collection/recording/reporting.  (Note: 
Serious and non-serious adverse events are to be collected through 16 weeks after 
the last dose of investigational product) 
• 
Adverse device effects collection/recording/reporting 
Section:  7.2.24 Open-label Treatment Phase, Paragraph 2 
Replace: 
A subject who discontinues open-label investigational product or the study during the 
open-label treatment phase will complete the week 76/early termination (ET) visit and 
the safety follow-up visit 16 weeks after the last dose of investigational product. 
With: 
A subject who discontinues open-label investigational product or the study during the 
OLTP will complete the week 100/early termination (ET) visit and the safety follow-up 
visit 16 weeks after the last dose of investigational product. 
Section:  7.2.25 Clinical Home Use Substudy (Optional) 
Add: 
7.2.25 Clinical Home Use Substudy (Optional) 
The following procedures are to be completed during the OLTP at time points 
designated in the Schedule of Assessments (Table 4).  At each CHU substudy 
visit, any assessments scheduled for the main 20120309 study visit should also 
be completed. 
Screening: 
• 
Obtain consent to CHU substudy 
• 
Review of IFU for AI/pen with subject 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 45 of 80 
• 
Register CHU consent date using the IVR/IWR System (via Additional Product 
Dispensing activity)  
• 
Review for adverse events/adverse device effects/serious adverse events 
Day 1: 
• 
After confirming subject eligibility, the following procedures are to be 
completed: 
• 
Register CHU randomization to randomize the subject to two 70 mg/mL 
AIs/pens or one 140 mg/mL AI/pen self-administration using the IVR/IWR 
System (via Additional Product Dispensing activity) 
− 
Site to instruct subject on how to self-administer AMG 334 with the AI/pen 
by reviewing entire IFU 
− 
Physical examination of subject with particular attention to any skin 
abnormalities in areas that might be used for IP self-administration 
− 
Subject self-administration using the AI/pen under site supervision 
− 
Review for adverse events/adverse device effects/serious adverse events 
− 
Product complaint recording (if applicable)  
− 
Study coordinator to reconcile IP (AI/pen) 
Day 28:   
• 
Study coordinator dispenses AI/pen to subject for self-administration on 
day 29 (IP device assigned using the IVR/IWR system via Additional Product 
Dispensing activity) 
• 
Review for adverse events/adverse device effects/serious adverse events 
• 
Product complaint recording (if applicable)  
• 
Telephone call time scheduled for day 29 (Note, telephone visit must occur 
after subject has self-administered IP) 
Day 29: 
• 
Subject self-administers AMG 334 using AI/pen in non-clinic setting 
• 
Telephone visit with study coordinator to inquire of subject if the subject 
administered a full, partial, or no dose of AMG 334 
• 
If the subject was not able to administer a full dose of AMG 334, the site staff 
will inquire further to determine if the subject experienced a device failure or 
use error that prevented the full-dose administration 
• 
Review adverse events/adverse device effects/serious adverse events  
• 
Product complaint recording (if applicable)  
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 46 of 80 
Day 56: 
• 
Subject returns IP for Study Coordinator to reconcile IP (AI/pen) 
• 
Study coordinator dispenses AI/pen to subject for self-administration on 
day 57 (IP device assigned using the IVR/IWR system via Additional Product 
Dispensing activity) 
• 
Review for adverse events/adverse device effects/serious adverse events 
• 
Product complaint recording (if applicable)  
• 
Telephone call time scheduled for day 57 (Note, telephone visit must occur 
after subject has self-administered IP) 
Day 57: 
• 
Subject self-administers AMG 334 using AI/pen in the non-clinical setting 
• 
Telephone visit with study coordinator to inquire of subject if the subject 
administered a full, partial, or no dose of AMG 334 
• 
If the subject was not able to administer a full dose of AMG 334, the site staff 
will inquire further to determine if the subject experienced a device failure or 
use error that prevented the full-dose administration 
• 
Review adverse events/adverse device effects/serious adverse events  
• 
Product complaint recording (if applicable)  
Day 85:  End of CHU substudy   
• 
Subject returns IP for study coordinator to reconcile IP (AI/pen) 
• 
Review adverse events/adverse device effects/serious adverse events  
• 
Product complaint recording (if applicable)  
• 
Subject continues all 20120309 study assessments and IP is administered at 
site as per the 20120309 protocol  
Section:  7.2.26 Safety Follow-up / End of Study Visit, Bullet 11 and 12 
Add: 
• 
Serious and non-serious adverse event collecting/recording/reporting.  (Note: 
Serious and non-serious adverse events are to be collected through 16 weeks after 
the last dose of investigational product) 
• 
Adverse device effect/recording/reporting 
• 
Product complaint recording 
CONFIDENTIAL 
 
 
 
 

Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 47 of 80 
Section:  7.6 Sample Storage and Destruction, Paragraph 1 
Add: 
Any sample collected according to the Schedule of Assessments (Table 2-Table 3) can 
be analyzed for any of the tests outlined in the protocol and for any tests necessary to 
minimize risks to study subjects. 
Section:  8.1 Subjects’ Decision to Withdraw, Paragraph 1 
Replace: 
If this occurs, the investigator is to discuss with the subject the appropriate processes for 
discontinuation from investigational product and must discuss with the subject the 
options for continuation of the Schedule of Assessments (Table 3) and collection of data, 
including endpoints and adverse events.  The investigator must document the change to 
the Schedule of Assessments (Table 3) and the level of follow up that is agreed to by the 
subject (eg, in person, by telephone/mail, through family/friends, in 
correspondence/communication with other physicians, from review of the medical 
records). 
With: 
If this occurs, the investigator is to discuss with the subject the appropriate processes for 
discontinuation from investigational product and must discuss with the subject the 
options for continuation of the Schedule of Assessments (Table 2-Table 4) and 
collection of data, including endpoints, adverse events, adverse device effects 
(if applicable), and serious adverse events.  The investigator must document the 
change to the Schedule of Assessments (Table 2-Table 4) and the level of follow-up 
that is agreed to by the subject (eg, in person, by telephone/mail, through family/friends, 
in correspondence/communication with other physicians, from review of the medical 
records). 
Section:  9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects 
That do not Meet Serious Criteria, Header and Paragraph 1 
Replace: 
9.2.1 Reporting Procedures for Adverse Events That do not Meet Serious Criteria 
The investigator is responsible for ensuring that all adverse events observed by the 
investigator or reported by the subject that occur after the first dose of investigational 
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Product:  AMG 334 
Protocol Number:  20120309 
Date:  05 June 2017 
Page 48 of 80 
product through the end of the safety follow-up visit (16 weeks after the last dose of 
investigational product) are reported using the Event CRF (eg, Adverse Event 
Summary), including events that are reported to the Event Adjudication Committee for 
adjudication. 
With: 
9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects That do 
not Meet Serious Criteria 
The investigator is responsible for ensuring that all adverse events and adverse device 
effects (including the OLTP and CHU substudy) observed by the investigator or 
reported by the subject that occur after the first dose of investigational product through 
the end of the safety follow-up visit (16 weeks after the last dose of investigational 
product) are reported using the Event CRF (eg, Adverse Event Summary), including 
events that are reported to the Event Adjudication Committee for adjudication. 
Section:  9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects 
That do not Meet Serious Criteria, Paragraph 2, Bullet 4 
• 
Replace: 
• 
assessment of relatedness to investigational product (medicine and/or pre-filled 
syringe), and 
With: 
• 
assessment of relatedness to investigational product (AMG 334 / placebo), and/or 
the Amgen medical devices (pre-filled syringe or the AI/Pen), and/or 
study-mandated procedure/study activity, and 
Section:  9.2.1 Reporting Procedures for Adverse Events and Adverse Device Effects 
That do not Meet Serious Criteria, Paragraph 3 
Replace: 
The adverse event grading scale used will be the Common Terminology Criteria for 
Adverse Events (CTCAE).  The grading scale used in this study is described in 
Appendix A.  The investigator must assess whether the adverse event is possibly related 
to the investigational product (medicine and/or pre-filled syringe).  This relationship is 
indicated by a “yes” or “no” response to the question:  “Is there a reasonable possibility 
that the event may have been caused by the investigational product (medicine and/or 
pre-filled syringe)?”   
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Date:  05 June 2017 
Page 49 of 80 
With: 
The adverse event grading scale used will be the CTCAE.  The grading scale used in 
this study is available at the following location:  
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.   
During the double-blind treatment period, the investigator must assess whether the 
adverse event is possibly related to the investigational medicinal product 
(AMG 334/placebo).  This relationship is indicated by a “yes” or “no” response to the 
question:  “Is there a reasonable possibility that the event may have been caused by the 
investigational medicinal product (AMG 334/placebo)?”   
During the OLTP and the CHU substudy, the investigator must assess whether the 
adverse event is possibly related to AMG 334.  This relationship is indicated by a 
“yes” or “no” response to the question:  “Is there a reasonable possibility that the 
event may have been caused by AMG 334?”   
During the OLTP and the CHU substudy, the investigator must assess whether the 
adverse event is possibly related to the prefilled syringe or AI/Pen (investigational 
medical devices used to administer AMG 334).  The relationship is indicated by a 
“yes” or “no” response to the question: Is there a reasonable possibility that the 
event may have been caused by the investigational medical devices? 
The investigator must assess whether the adverse event is possibly related to any 
study-mandated activity (eg, administration of investigational product, 
protocol-required therapies, device(s) and/or procedure (including any screening 
procedure(s)).  This relationship is indicated by a “yes” or “no” response to the 
question:  “Is there a reasonable possibility that the event may have been caused 
by a study activity (eg, administration of investigational product, 
protocol-required therapies, device(s)), and/or procedure”? 
Relatedness means that there are facts or reasons to support a relationship 
between investigational product and the event. 
Section:  9.2.2 Reporting Procedures for Serious Adverse Events 
Add: 
The investigator is responsible for ensuring that all serious adverse events (this 
includes the CHU substudy) observed by the investigator or reported by the subject 
that occur after signing of the informed consent through the end of the safety follow-up 
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Page 50 of 80 
visit (16 weeks after the last dose of investigational product) are recorded in the 
subject’s medical record and are submitted to Amgen, including serious adverse events 
that are reported to the Event Adjudication Committee for adjudication. 
If the electronic data capture (EDC) system is unavailable to the site staff to report 
the serious adverse event, the information is to be reported to Amgen via an 
electronic Serious Adverse Event (eSAE) Contingency Report Form within 
24 hours of the investigator’s knowledge of the event.  See Appendix B for a 
sample of the Serious Adverse Event Worksheet/electronic Serious Adverse Event 
Contingency Report Form.  For EDC studies where the first notification of a 
Serious Adverse Event is reported to Amgen via the eSerious Adverse Event 
Contingency Report Form, the data must be entered into the EDC system when 
the system is again available. 
During the double-blind treatment period, the investigator must assess whether 
the serious adverse event is possibly related to the investigational medicinal 
product (AMG 334 / placebo).  This relationship is indicated by a “yes” or “no” 
response to the question:  “Is there a reasonable possibility that the event may 
have been caused by the investigational medicinal product (AMG 334 / placebo)?”   
During the OLTP and the CHU substudy, the investigator must assess whether the 
serious adverse event is possibly related to AMG 334.  This relationship is 
indicated by a “yes” or “no” response to the question:  “Is there a reasonable 
possibility that the event may have been caused by AMG 334?”   
During the OLTP and the CHU substudy, the investigator must assess whether the 
serious adverse event is possibly related to the prefilled syringe or AI/Pen 
(investigational medical devices used to administer AMG 334).  The relationship is 
indicated by a “yes” or “no” response to the question: Is there a reasonable 
possibility that the event may have been caused by the investigational medical 
devices? 
The investigator must assess whether the serious adverse event is possibly 
related to any study-mandated activity (eg, administration of investigational 
product, protocol-required therapies, device(s) and/or procedure (including any 
screening procedure(s)).  This relationship is indicated by a “yes” or “no” 
response to the question:  “Is there a reasonable possibility that the event may 
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have been caused by a study activity (eg, administration of investigational 
product, protocol-required therapies, device(s)), and/or procedure”? 
Relatedness means that there are facts or reasons to support a relationship 
between investigational product and the event. 
Section:  9.2.2 Reporting Procedures for Serious Adverse Events (unamended text was 
moved from Section 9.2.3 to the end of Section 9.2.2) 
Add: 
The investigator is expected to follow reported serious adverse events until stabilization 
or reversibility.  
New information relating to a previously reported serious adverse event must be 
submitted to Amgen.  All new information for serious adverse events must be sent to 
Amgen within 24 hours following knowledge of the new information.  The investigator 
may be asked to provide additional follow-up information, which may include a discharge 
summary or extracts from the medical record.  Information provided about the serious 
adverse event must be consistent with that recorded on the applicable CRF (eg, Adverse 
Event Summary CRF). 
If a subject is permanently withdrawn from protocol-required therapies because of a 
serious adverse event, this information must be submitted to Amgen. 
To comply with worldwide reporting regulations for serious adverse events, the treatment 
assignment of subjects who develop serious, unexpected, and related adverse events 
may be unblinded by Amgen before submission to regulatory authorities.  Investigators 
will receive notification of related serious adverse events reports sent to regulatory 
authorities in accordance with local requirements.   
Amgen will report serious adverse events and/or suspected unexpected serious adverse 
reactions as required to regulatory authorities, investigators/institutions, and IRBs in 
compliance with all reporting requirements according to local regulations and good 
clinical practice.  
The investigator is to notify the appropriate IRB of serious adverse events occurring at 
the site and other adverse event reports received from Amgen, in accordance with local 
procedures and statutes. 
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Section:  9.2.3 Reporting Serious Adverse Events After the Protocol-required Reporting 
Period, Paragraph 2 and 3 
Delete: 
If the electronic data capture (EDC) system is unavailable to the site staff to report the 
serious adverse event, the information is to be reported to Amgen via an electronic 
Serious Adverse Event (eSAE) Contingency Report Form within 24 hours of the 
investigator’s knowledge of the event.  See Appendix B for a sample of the Serious 
Adverse Event Worksheet/electronic Serious Adverse Event Contingency Report Form.  
For EDC studies where the first notification of a Serious Adverse Event is reported to 
Amgen via the eSerious Adverse Event Contingency Report Form, the data must be 
entered into the EDC system when the system is again available. 
The investigator must assess whether the serious adverse event is possibly related to 
any study-mandated activity or procedure.  This relationship is indicated by a “yes” or 
“no” response to the question:  “Is there a reasonable possibility that the event may have 
been caused by a study activity/procedure?”  
Section:  9.4 Pregnancy and Lactation Reporting 
Replace: 
If a pregnancy occurs in a female subject, or female partner of a male subject, while the 
subject is taking investigational product, report the pregnancy to Amgen as specified 
below. 
In addition to reporting any pregnancies occurring during the study, investigators should 
monitor for pregnancies that occur through 16 weeks after the last dose of 
investigational product.  
The pregnancy should be reported to Amgen’s global Pregnancy Surveillance Program 
within 24 hours of the investigator’s knowledge of the event of a pregnancy.  Report a 
pregnancy on the Pregnancy Notification Worksheet (Appendix C).  The Pregnancy 
Surveillance Program (PSP) will seek to follow the pregnant woman throughout her 
pregnancy and her baby up to 12 months after birth. 
If a lactation case occurs while the female subject is taking protocol-required therapies, 
report the lactation case to Amgen as specified below.  
In addition to reporting a lactation case during the study, investigators should monitor for 
lactation cases that occur 16 weeks after the last dose of investigational product.  
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Any lactation case should be reported to Amgen’s global Lactation Surveillance Program 
(LSP) within 24 hours of the investigator’s knowledge of event.  Report a lactation case 
on the Lactation Notification Worksheet (Appendix D). 
With: 
If a female subject becomes pregnant, or a male subject fathers a child, while the 
subject is taking investigational product/product-required therapies, report the 
pregnancy to Amgen Global Patient Safety as specified below. 
In addition to reporting any pregnancies occurring during the study, investigators should 
report pregnancies that occur through 16 weeks after the last dose of investigational 
product/protocol-required therapies.  
The pregnancy should be reported to Amgen Global Patient Safety within 24 hours of 
the investigator’s knowledge of the event of a pregnancy.  Report a pregnancy on the 
Pregnancy Notification Worksheet (Appendix C).  Amgen Global Patient Safety will 
follow-up with the investigator regarding additional information that may be 
requested. 
If a female subject becomes pregnant during the study, the investigator should 
attempt to obtain information regarding the birth outcome and health of the infant.  
If the outcome of the pregnancy meets a criterion for immediate classification as a 
serious adverse event (eg, female subject experiences a spontaneous abortion, 
stillbirth, or neonatal death or there is a fetal or neonatal congenital anomaly) the 
investigator will report the event as a serious adverse event.  
If a female breastfeeds while taking investigational product/protocol-required 
therapies report the lactation case to Amgen as specified below.  
Any lactation case should be reported to Amgen Global Patient Safety within 24 hours 
of the investigator’s knowledge of event.  Report a lactation case on the Lactation 
Notification Worksheet (Appendix D).  Amgen Global Patient Safety will follow-up 
with the investigator regarding additional information that may be requested. 
In addition to reporting a lactation case during the study, investigators should monitor for 
lactation cases that occur 16 weeks after the last dose of investigational 
product/protocol-required therapies. 
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If a male subject's female partner becomes pregnant, the investigator should 
discuss obtaining information regarding the birth outcome and health of the infant 
from the pregnant partner. 
Section:  10.1.1.4 Clinical Home Use Substudy 
Add: 
10.1.1.4 
Clinical Home Use Substudy 
10.1.1.4.1 
Primary Endpoint 
• 
Subject-reported outcome of attempted full-dose administration on day 29 and 
day 57 
10.1.1.4.2 
Secondary Endpoint 
• 
Subject incidence of adverse events, serious adverse events, and adverse 
device effects 
Section:  10.1.1.5 Definitions of Terms Included in Endpoints, Acute Headache 
Medication Treatment Day 
Add: 
Acute Headache Medication Treatment Day:  Any calendar day during which the 
subject took an acute headache medication (migraine-specific or 
non-migraine-specific). 
Section:  10.1.1.5 Definitions of Terms Included in Endpoints, Monthly eDiary Data 
Replace: 
Data collected by the eDiary in any 28-consecutive day interval relative to study day 1 
when more than 14 days of eDiary data are collected within that 28-consecutive day 
interval. 
With: 
Data collected by the eDiary in any 28-consecutive day interval relative to study day 1 
when at least 14 days of eDiary data are collected within that 28-consecutive day 
interval.  Monthly frequency measurements will be prorated to 28-day equivalents.   
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Section:  10.1.2 Analysis Sets, Paragraph 1 
Replace: 
The efficacy analysis set includes subjects in the FAS and who received at least one 
dose of investigational product and completed at least one post-baseline monthly 
migraine day measurement in the double-blind treatment phase.   
With: 
The efficacy analysis set includes subjects in the FAS and who received at least one 
dose of investigational product and had at least one change from baseline 
measurement in monthly migraine days during the double-blind treatment phase.   
Section:  10.1.2 Analysis Sets, Paragraph 1 
Replace: 
For safety endpoints, all randomized subjects who received at least one dose of 
investigational product (ie, safety analysis set) will be analyzed based on actual 
treatment received.   
With: 
For safety endpoints, all randomized subjects who received at least one dose of 
investigational product (ie, safety analysis set) will be analyzed according to the 
randomized treatment unless a subject has received the incorrect dose during the 
entire double-blind treatment phase.   
Section:  10.1.2 Analysis Sets, Paragraph 2 
Add: 
All subjects enrolled in the CHU substudy will be included in the CHU substudy 
analysis set. 
Section:  10.1.3 Covariates and Subgroups 
Replace: 
The primary, secondary efficacy, and selected safety endpoints will be analyzed in the 
subgroups defined by the stratification factor as well as age (< median vs ≥ median), 
sex, race, body mass index (BMI; < median vs ≥ median), and duration of disease 
(< median vs ≥ median). 
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With: 
The primary, secondary efficacy, and selected safety endpoints will be analyzed in the 
subgroups defined by the stratification factor as well as baseline monthly migraine 
days (< 8 days vs ≥ 8 days), prior prophylactic failure status (failed any vs not 
failed any), and BMI (< median vs ≥ median).  
Section:  10.2 Sample Size Considerations, Paragraph 2 
Add: 
Clinical Home Use Substudy 
Approximately 50 subjects will be enrolled in to the CHU substudy.  The following 
assumptions are made based on the minimum sample size of 50 subjects:  5% of 
subjects per treatment group discontinue IP and 90% of the remaining subjects 
respond that they administered a full dose.  As such, the anticipated distribution 
of responses per treatment group at a planned visit would be 5% categorized as 
not attempting due to discontinuing IP, 85.5% responding that they administered a 
full dose, and 9.5% responding that they did not administer a full dose.  The 
associated 95% confidence interval halfwidths with 25 subjects per group are 
8.5%, 13.8%, and 11.5%, respectively.  The anticipated 95% confidence interval 
half width for the difference between treatment groups in the proportion of 
subjects administering a full dose is 19.5%.  The discontinuation rate is expected 
to be less than 5% and the rate of administering a full dose is expected to be 
greater than 90%, and therefore these calculations are anticipated to be lower 
bounds.  Calculations were performed using nQuery Advisor 7.0. 
Section:  10.4.2 Interim Analysis, Paragraph 1 
Replace: 
During the open-label treatment phase of the study, an interim analysis is planned after 
at least 100 subjects randomized to 70 mg of AMG 334 have completed 52 weeks of 
treatment with investigational product. 
With: 
During the OLTP of the study, an interim analysis is planned after at least 100 subjects 
randomized to 140 mg of AMG 334 have completed 26 and 52 weeks of treatment with 
investigational product. 
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Section:  10.4.4 Final Analysis, Paragraph 1 
Replace: 
The objective of the final analysis is to evaluate the long-term profile of migraine days 
and adverse events of AMG 334 in subjects with migraine after the 24-week double-blind 
treatment phase, 52-week open-label treatment phase, and safety follow up. 
With: 
The objective of the final analysis is to evaluate the long-term profile of migraine days 
and adverse events of AMG 334 in subjects with migraine after the 24-week double-blind 
treatment phase, OLTP, and safety follow-up.  
Section:  10.4.4 Final Analysis, Paragraph 2 
Replace: 
Final Analysis activities are commenced based on achieving the End of Trial milestone 
described in Section 3.5.2. 
With: 
Final Analysis activities are commenced based on achieving the End of Trial milestone 
described in Section 3.6.2.  
Section:  10.5.1 General Considerations, Paragraph 7 
Add: 
The proportion of subjects who administer a full dose of AMG 334 in home-use 
will be summarized by treatment group at CHU day 29 and day 57.  For all subjects 
who have not discontinued IP, a subject report of full dose administration will be 
considered a “yes” response, and a subject report of partial or no dose 
administered will be considered a “no” response.  The proportion of each 
possible pattern of responses across the 2 visits will also be estimated.  
Ninety-five percent confidence intervals will be provided for each group and the 
difference in proportions between the groups.  Subject incidence of adverse 
events, serious adverse events, and adverse device effects will be summarized by 
system organ class and preferred term for subjects enrolled in the CHU 
substudies.  Details of the analysis of the CHU substudy will be described in a 
separate Statistical Analysis Plan. 
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Section:  10.5.2 Primary Efficacy Endpoint, Paragraph 2 
Replace: 
Sensitivity analyses for the primary endpoint include: (1) the same analysis using the 
per-protocol analysis set, (2) the last observation carried forward (LOCF) to handle 
missing data, and (3) the inverse probability weighted (IPW) method using generalized 
estimate equation (GEE) to handle missing data. 
With: 
Sensitivity analyses for the primary endpoint include: (1) the same analysis using the 
per-protocol analysis set, (2) the last observation carried forward (LOCF) to handle 
missing data with analysis of covariance (ANCOVA) model, and (3) multiple 
imputation (MI) with assumptions of missing at random (MAR) and missing not at 
random (MNAR) to handle missing data.  
Section:  10.5.3 Secondary Efficacy Endpoints, Paragraph 1 
Replace: 
The odds ratio for each AMG 334 treatment group vs placebo group and associated 
95% confidence intervals will be reported. Sensitivity analyses for response include: 
(1) the same analysis using the per-protocol analysis set, and (2) the logistic regression 
model adjusting for baseline values where missing values will be imputed as 
non-responders. 
With: 
The odds ratio for each AMG 334 treatment group vs placebo group and associated 
95% confidence intervals will be reported.  Sensitivity analyses for the binary endpoint 
include: (1) CHM test using the per-protocol analysis set, and (2) generalized linear 
mixed model without imputation of missing data, and (3) logistic regression model 
for each visit after the missing data are imputed as non-responders.  
Section:  10.5.5 Safety Endpoints, Paragraph 1 
Replace: 
For safety endpoints, all randomized subjects who received at least one dose of 
investigational product (ie, safety analysis set) will be analyzed based on the actual 
treatment received. 
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With: 
For safety endpoints, all randomized subjects who received at least one dose of 
investigational product (ie, safety analysis set) will be analyzed according to the 
randomized treatment unless a subject has received the incorrect dose during the 
entire double-blind treatment phase.  
Section:  10.5.5 Safety Endpoints, Paragraph 3 
Replace: 
Subject incidence rates (double-blind treatment phase) and subject incidence rates 
adjusted for follow-up time (open-label treatment phase) of all treatment-emergent 
adverse events will be tabulated by treatment groups and by system organ class and 
preferred term. 
With: 
Subject incidence rates (double-blind treatment phase) and exposure-adjusted subject 
incidence rates (OLTP) of all treatment-emergent adverse events will be tabulated by 
treatment groups and by system organ class and preferred term.  
Section:  10.5.5 Safety Endpoints, Paragraph 4 
Replace: 
The analyses of safety laboratory endpoints will include summary statistics over time by 
treatment group.  Shift tables of the worst on-study safety laboratory toxicity based on 
grade relative to baseline will be tabulated by treatment group.  Subject listing of grades 
≥ 3 laboratory toxicities will be provided. 
Add: 
The analyses of safety laboratory endpoints will include summary statistics over time by 
treatment group for selected analytes.  Shift tables of the worst on-study safety 
laboratory toxicity based on grade relative to baseline will be tabulated by treatment 
group. 
Section:  12.4 Investigator Responsibilities for Data Collection 
Add: 
For subjects who withdraw prior to completion of all protocol-required visits and are 
unable or unwilling to continue the Schedule of Assessments (Table 2-Table 4), the 
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investigator can search publically available records (where permitted) to ascertain 
survival status. 
Section:  12.6 Publication Policy, Paragraph 1 
Replace: 
To coordinate dissemination of data from this study, Amgen encourages the formation of 
a publication committee consisting of several investigators and appropriate Amgen staff, 
the governance and responsibilities of which are set forth in a Publication Charter. 
With: 
To coordinate dissemination of data from this study, Amgen may facilitate the formation 
of a publication committee consisting of several investigators and appropriate Amgen 
staff, the governance and responsibilities of which are set forth in a Publication Charter. 
Section:  12.6 Publication Policy, Paragraph 2 
Add: 
Authorship of any publications resulting from this study will be determined on the basis 
of the Recommendations for the Conduct, Reporting, Editing, and Publication of 
Scholarly Work in Medical Journals (International Committee of Medical Journal Editors, 
2013, updated 2014), which states: 
Section:  13 References, Reference 19 
Add: 
International Committee of Medical Journal Editors.  Recommendations for the Conduct, 
Reporting, Editing, and Publication of Scholarly Work in Medical Journals. 2013, 
updated 2014.  http://www.icmje.org/.  Accessed 19 September 2013.  
Section:  14 Appendices, Appendix A  
Replace: 
Appendix A.  Additional Safety Assessment Information 
Adverse Event Grading Scale 
The Common Terminology Criteria for Adverse Events Version 4 (CTCAE v4) is 
available at the following location:  
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm 
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Drug-induced Liver Injury Reporting & Additional Assessments  
Reporting 
To facilitate appropriate monitoring for signals of DILI, cases of concurrent AST or ALT 
and TBL and/or INR elevation according to the criteria specified in Section 6.3 require 
the following: 
• 
The event is to be reported to Amgen as a serious adverse event within 24 hours of 
discovery or notification of the event (ie, before additional etiologic investigations 
have been concluded) 
• 
The appropriate CRF (eg, Adverse Event CRF) that captures information necessary 
to facilitate the evaluation of treatment-emergent liver abnormalities is to be 
completed and sent to Amgen.  
Other events of hepatotoxicity and potential DILI are to be reported as serious adverse 
events if they meet the criteria for a serious adverse event defined in Section 9.2.2. 
Additional Clinical Assessments and Observation 
All subjects in whom investigational product is withheld (either permanently or 
conditionally) due to potential DILI as specified in Sections 6.3.1 and 6.3.2 or who 
experience AST or ALT elevations > 3 x ULN are to undergo a period of “close 
observation” until abnormalities return to normal or to the subject’s baseline levels.  
Assessments that are to be performed during this period include:  
• 
Repeat AST, ALT, ALP, bilirubin (total and direct), and INR within 24 hours  
• 
In cases of TBL > 2x ULN or INR > 1.5, retesting of liver tests, BIL (total and direct), 
and INR is to be performed every 24 hours until laboratory abnormalities improve 
Testing frequency of the above laboratory tests may decrease if the abnormalities 
stabilize or the investigational product has been discontinued AND the subject is 
asymptomatic. 
• 
Initiate investigation of alternative causes for elevated AST or ALT and/or elevated 
TBL: 
− 
Obtain complete blood count (CBC) with differential to assess for eosinophilia 
− 
Obtain serum total immunoglobulin IgG, Anti-nuclear antibody (ANA), Anti 
Smooth Muscle Antibody, and Liver Kidney Microsomal antibody 1 (LKM1) to 
assess for autoimmune hepatitis 
− 
Obtain serum acetaminophen (paracetamol) levels 
− 
Obtain a more detailed history of:  
o Prior and/or concurrent diseases or illness 
o Exposure to environmental and/or industrial chemical agents  
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o Symptoms (if applicable) including right upper quadrant pain, 
hypersensitivity-type reactions, fatigue, nausea, vomiting and fever 
o Prior and/or concurrent use of alcohol, recreational drugs and special diets 
o Concomitant use of medications (including non-prescription medicines and 
herbal and dietary supplements), plants, and mushrooms 
− 
Obtain viral serologies 
− 
Obtain CPK, haptoglobin, LDH, and peripheral blood smear 
− 
Perform appropriate liver imaging if clinically indicated 
• 
Obtain appropriate blood sampling for pharmacokinetic analysis if this has not 
already been collected  
• 
Obtain hepatology consult (liver biopsy may be considered in consultation with an 
hepatologist) 
• 
Follow the subject and the laboratory tests (ALT, AST, TBL, INR) until all laboratory 
abnormalities return to baseline or normal.  The “close observation period” is to 
continue for a minimum of 4 weeks after discontinuation of investigational product. 
The potential DILI event and additional information such as medical history, concomitant 
medications and laboratory results must be captured in corresponding CRFs. 
With: 
Appendix A.  Hepatoxicity Stopping Rules:  Suggested Actions and Follow-up 
Assessments and Study Treatment Rechallenge Guidelines 
Subjects with abnormal hepatic laboratory values (ie, alkaline phosphatase [ALP], 
aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin 
[TBL]) and/or international normalized ratio [INR] and/or signs/symptoms of 
hepatitis (as described below) may meet the criteria for withholding or permanent 
discontinuation of Amgen investigational product or other protocol-required 
therapies, as specified in the Guidance for Industry Drug-Induced Liver Injury:  
Premarketing Clinical Evaluation, July 2009. 
Criteria for Withholding and/or Permanent Discontinuation of Amgen 
Investigational Product Therapies Due to Potential Hepatotoxicity 
The following stopping and/or withholding rules apply to subjects for whom 
another cause of their changes in liver biomarkers (TBL, INR, and transaminases) 
has not been identified. 
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Important alternative causes for elevated AST/ALT and/or TBL values include, but 
are not limited to: 
• 
Hepatobiliary tract disease 
• 
Viral hepatitis (eg, Hepatitis A/B/C/D/E, Epstein-Barr Virus, cytomegalovirus, 
herpes simplex virus, varicella, toxoplasmosis, and parvovirus) 
• 
Right sided heart failure, hypotension, or any cause of hypoxia to the liver 
causing ischemia   
• 
Exposure to hepatotoxic agents/drugs or hepatotoxins, including herbal and 
dietary supplements, plants, and mushrooms   
• 
Heritable disorders causing impaired glucuronidation (eg, Gilbert’s Syndrome, 
Crigler-Najjar syndrome) and drugs that inhibit bilirubin glucuronidation 
(eg, indinavir, atazanavir) 
• 
Alpha-one antitrypsin deficiency 
• 
Alcoholic hepatitis 
• 
Autoimmune hepatitis  
• 
Wilson’s disease and hemochromatosis 
• 
Nonalcoholic fatty liver disease including steatohepatitis (NASH)  
• 
Non-hepatic causes (eg, rhabdomylosis, hemolysis) 
If investigational product is withheld, the subject is to be followed according for 
possible DILI according to recommendations in the last section of this appendix. 
Rechallenge may be considered if an alternative cause for impaired liver tests 
(ALT, AST, ALP) and/or elevated TBL, is discovered and the laboratory 
abnormalities resolve to normal or baseline (see next section in this appendix). 
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Table 6.  Conditions for Withholding and/or Permanent Discontinuation of Amgen 
Investigational Product and Other Protocol-required Therapies Due to Potential 
Hepatotoxicity 
Analyte 
Temporary Withholding 
Permanent Discontinuation 
TBL 
> 3x ULN  
at any time 
> 2x ULN 
 
 
OR 
INR 
-- 
> 1.5x ULN (for subjects not on 
anticoagulation therapy) 
 
OR 
AND 
AST/ALT 
> 8x ULN at any time 
> 5x ULN but < 8x ULN for ≥ 2 
weeks 
> 5x ULN but < 8x ULN and unable 
to adhere to enhanced monitoring 
schedule 
> 3x ULN with clinical signs or 
symptoms that are consistent with 
hepatitis (such as right upper 
quadrant pain/tenderness, fever, 
nausea, vomiting, and jaundice) 
In the presence of no important 
alternative causes for elevated 
AST/ALT and/or TBL values 
> 3x ULN (when baseline was 
< ULN) 
 
OR 
ALP 
> 8x ULN at any time 
-- 
ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
INR = international normalized ratio; TBL = total bilirubin; ULN = upper limit of normal 
Criteria for Rechallenge of Amgen Investigational Product Therapies After 
Potential Hepatotoxicity 
The decision to rechallenge the subject should be discussed and agreed upon 
unanimously by the subject, investigator, and Amgen. 
If signs or symptoms recur with rechallenge, then Amgen investigational product 
is to be permanently discontinued.  Subjects who clearly meet the criteria for 
permanent discontinuation (as described in Table 6) are never to be rechallenged. 
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Drug-induced Liver Injury Reporting & Additional Assessments  
Reporting 
To facilitate appropriate monitoring for signals of DILI, cases of concurrent AST or ALT 
and TBL and/or INR elevation according to the criteria specified above, require the 
following: 
• 
The event is to be reported to Amgen as a serious adverse event within 24 hours of 
discovery or notification of the event (ie, before additional etiologic investigations 
have been concluded) 
• 
The appropriate CRF (eg, Adverse Event CRF) that captures information necessary 
to facilitate the evaluation of treatment-emergent liver abnormalities is to be 
completed and sent to Amgen.  
Other events of hepatotoxicity and potential DILI are to be reported as serious adverse 
events if they meet the criteria for a serious adverse event defined in Section 9.2.2. 
Additional Clinical Assessments and Observation 
All subjects in whom investigational product is withheld (either permanently or 
conditionally) due to potential DILI as specified in Table 6 or who experience AST or 
ALT elevations > 3 x upper limit of normal (ULN) or 2-fold increases above baseline 
values for subjects with elevated values before drug are to undergo a period of 
“close observation” until abnormalities return to normal or to the subject’s baseline 
levels.   
Assessments that are to be performed during this period include:  
• 
Repeat AST, ALT, ALP, bilirubin (total and direct), and INR within 24 hours  
• 
In cases of TBL > 2x ULN or INR > 1.5, retesting of liver tests, BIL (total and direct), 
and INR is to be performed every 24 hours until laboratory abnormalities improve. 
• 
Testing frequency of the above laboratory tests may decrease if the abnormalities 
stabilize or the investigational product(s) or protocol-required therapies has/have 
been discontinued AND the subject is asymptomatic. 
• 
Initiate investigation of alternative causes for elevated AST or ALT and/or elevated 
TBL.  The following are to be considered depending on the clinical situation: 
• 
Complete blood count (CBC) with differential to assess for eosinophilia 
• 
Serum total immunoglobulin IgG, anti-nuclear antibody (ANA), anti smooth 
muscle antibody, and liver kidney microsomal antibody -1 (LKM1) to assess for 
autoimmune hepatitis 
• 
Serum acetaminophen (paracetamol) levels 
• 
A more detailed history of:  
• 
Prior and/or concurrent diseases or illness 
• 
Exposure to environmental and/or industrial chemical agents  
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• 
Symptoms (if applicable) including right upper quadrant pain, 
hypersensitivity-type reactions, fatigue, nausea, vomiting and fever 
• 
Prior and/or concurrent use of alcohol, recreational drugs and special diets 
• 
Concomitant use of medications (including non-prescription medicines and 
herbal and dietary supplements), plants, and mushrooms 
• 
Viral serologies 
• 
Creatine phosphokinase (CPK), haptoglobin, lactate dehydrogenase (LDH), 
and peripheral blood smear 
• 
Appropriate liver imaging if clinically indicated 
• 
Appropriate blood sampling for pharmacokinetic analysis if this has not already been 
collected 
• 
Hepatology consult (liver biopsy may be considered in consultation with a 
hepatologist) 
• 
Follow the subject and the laboratory tests (ALT, AST, TBL, INR) until all laboratory 
abnormalities return to baseline or normal or considered stable by the 
investigator.  The “close observation period” is to continue for a minimum of 
4 weeks after discontinuation of all investigational product(s) and protocol-required 
therapies. 
The potential DILI event and additional information such as medical history, concomitant 
medications and laboratory results must be captured in the corresponding CRFs 
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Section:  14 Appendices, Appendix B 
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Appendix B.  Sample Serious Adverse Event Report 
Form
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With: 
Appendix B.  Sample Serious Adverse Event Contingency Report 
Form
 
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Section:  14 Appendices, Appendix C 
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Section:  14 Appendices, Appendix D 
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