A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia
Phase: PHASE2
Conditions: Severe Familial Hypercholesterolemia
Sponsor: Amgen

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NCT Number: 01624142
This NCT number has been applied to the document 
for purposes of posting on clinicaltrials.gov

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Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 1 of 18 
CONFIDENTIAL 
 
 
Amendment 6 
Protocol Title:  A Multicenter, Open-label Study to Assess the Long-term Safety, 
Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial 
Hypercholesterolemia 
 
Amgen Protocol Number (AMG 145) 20110271 
EudraCT Number: 2011-005400-15 
Amendment Date: 
02 December 2015 
 
Rationale: 
The protocol is being amended to: 
• 
Clarify end of study language to specify the study will end when the last patient 
has completed assessments at week 260. 
• 
Draw attention to collection of adverse device effects (ADEs) by adding ADEs to 
the Schedule of Assessments and the general study procedures when reviewing 
for adverse events (AEs) and serious adverse events (SAEs).  This information is 
already being collected under AEs. 
• 
Update criteria for possible drug-induced liver injury (DILI). 
• 
Clarify language regarding product complaints. 
• 
Allow for additional pregnancy testing at the discretion of the investigator. 
• 
Correct Tanner Staging criteria for males. 
• 
Update pregnancy and lactation reporting language and added new sample 
reporting forms. 
• 
Correct typographic, grammatical, and formatting errors throughout the protocol. 

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Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 3 of 18 
CONFIDENTIAL 
 
 
Section:  Title Page 
Add: 
Date: 
Amendment 1 Date: 
Amendment 2 Date: 
Amendment 3 Date: 
Amendment 4 Date: 
Amendment 5 Date: 
Amendment 6 Date: 
15 November 2011 
17 July 2012 
07 December 2012 
16 September 2013 
15 April 2014 
11 May 2015 
XX December 2015 
Section: Protocol Synopsis, Study Design 
Replace: 
A multicenter, open-label study designed to assess the long-term safety, tolerability, and 
efficacy of AMG 145.  The study will continue for 5 years or until AMG 145 becomes 
commercially available, whichever is earlier. 
With: 
A multicenter, open-label study designed to assess the long-term safety, tolerability, and 
efficacy of AMG 145.  The study will continue until the date when the last subject has 
completed the assessments for week 260 (approximately 5 years) or until the 
investigator’s recommendation of discontinuation, Amgen’s recommendation of 
discontinuation, the subject’s decision to discontinue for any reason, or until an 
administrative decision is made to close the study. 
Section: Protocol Synopsis, Summary of Subject Eligibility Criteria, last paragraph 
Replace: 
Female subjects cannot be pregnant or breast-feeding or planning to become pregnant 
or breastfeed and premenopausal females of childbearing potential must be willing to 
use an acceptable method(s) of birth control during treatment and for an additional 
15 weeks after the end of treatment with AMG 145 (IP). 
With: 
Female subjects cannot be pregnant or breast-feeding or planning to become pregnant 
or breastfeed and premenopausal females of childbearing potential must be willing to 
use an acceptable method(s) of birth control during treatment with AMG 145 (IP) and for 
an additional 15 weeks after the last dose of AMG 145 (IP). 
Section: Protocol Synopsis, Parent Study 20110233 Subjects 
Add: 
Subjects coming from parent study 20110233 will initiate this study with AMG 145 
420 mg SC monthly (QM) dosing. 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 4 of 18 
CONFIDENTIAL 
 
 
Section: Protocol Synopsis, Apheresis Subjects 
Add: 
Subjects on apheresis should initiate treatment with AMG 145 420 mg SC Q2W in this 
study to correspond with their apheresis schedule. 
Section: Study Design and Treatment Schema 
Add: 
 
Section: Study Glossary 
Add: 
ADE 
Adverse device effect 
ET OL 
Early termination open label 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for 
Adverse Events 
Section: Study Glossary 
Replace: 
End of treatment 
Defined as the last assessment for the protocol-specified treatment 
phase of the study for an individual subject 
EOS 
End-of-study for individual subject 
With: 
End of treatment 
Defined as the last dose for the protocol-specified treatment phase 
of the study for an individual subject 
EOS 
End of study 
Section: 2.2  AMG 145 Background, 2nd paragraph 
Add: 
Details of the biochemistry, nonclinical pharmacology, nonclinical pharmacokinetics 
(PK), and nonclinical toxicology with AMG 145 are contained in the Evolocumab 
(AMG 145) Investigator’s Brochure, 2013. 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 5 of 18 
CONFIDENTIAL 
 
 
Section: 2.3  Rationale 
Replace: 
This study is being conducted to gather information on the long-term safety of AMG 145 
and to provide subjects that participated in 20110233 or another Amgen qualifying study 
with an opportunity to receive treatment until AMG 145 becomes commercially available. 
With: 
This study is being conducted to gather information on the long-term safety of AMG 145 
and to provide subjects that participated in 20110233 or another Amgen qualifying study 
with an opportunity to receive treatment with AMG 145 for up to approximately 
5 years. 
Section: 3.1  Study Design, 1st paragraph 
Replace: 
A multicenter, open-label study designed to assess the long-term safety, tolerability, and 
efficacy of AMG 145.  The study will continue for 5 years or until AMG 145 becomes 
commercially available, whichever is earlier. 
With: 
A multicenter, open-label study designed to assess the long-term safety, tolerability, and 
efficacy of AMG 145.  The study will continue until the date when the last subject has 
completed the assessments for week 260 (approximately 5 years) or until the 
investigator’s recommendation of discontinuation, Amgen’s recommendation of 
discontinuation, the subject’s decision to discontinue for any reason, or until an 
administrative decision is made to close the study. 
Section: 3.4  Study Duration for Participants 
Replace: 
The study will continue for 5 years or until AMG 145 becomes commercially available, 
whichever is earlier. 
With: 
The study will continue for 260 weeks (approximately 5 years) or until the 
investigator’s recommendation of discontinuation, Amgen’s recommendation of 
discontinuation, the subject’s decision to discontinue for any reason, or until an 
administrative decision is made to close the study. 
Section: 3.5  End of Study 
Replace: 
The study will continue for 5 years or until AMG 145 becomes commercially available, 
whichever is earlier. 
With: 
The study will continue until the date when the last subject has completed the 
assessments for week 260 (approximately 5 years) or until the investigator’s 
recommendation of discontinuation, Amgen’s recommendation of 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 6 of 18 
CONFIDENTIAL 
 
 
discontinuation, the subject’s decision to discontinue for any reason, or until an 
administrative decision is made to close the study. 
Section: 4.2  Exclusion Criteria 
Add: 
4.2.2 Subject is pregnant or breastfeeding, or planning to become pregnant or 
breastfeed during treatment with AMG 145 (IP) and for an additional 15 weeks 
after the end of treatment with AMG 145 (IP) 
Section: 6.1.3.2  Elevation of Liver Function Tests, 2nd paragraph 
Replace: 
IP, statin and other applicable lipid background therapy must be discontinued and the 
subject should be followed according to the recommendations in Appendix B (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  
• 
AST or ALT > 3x ULN  
AND  
• 
no other cause for the combination of laboratory abnormalities is immediately 
apparent; important potential causes for abnormal AST/ALT or TBL values include, 
but are not limited to: 
With: 
IP, statin and other applicable lipid background therapy must be discontinued and the 
subject should be followed according to the recommendations in Appendix B (Additional 
Safety Assessment Information) for possible drug-induced liver injury (DILI), if ALL of the 
criteria below are met:  
• 
TBL ≥ 2x ULN 
• 
AND increased AST or ALT > 3x ULN if baseline values were less than the ULN 
• 
AND ALP < 2x ULN 
• 
AND no other cause for the combination of the above laboratory abnormalities is 
immediately apparent; important alternative causes for abnormal AST/ALT and/or 
TBL values include, but are not limited to: 
Section: 6.2  Product Complaints, Including Device Complaints, 1st paragraph 
Add: 
A product complaint is defined as any written, electronic or oral communication that 
alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a drug(s) or device(s) after it is released for distribution 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 7 of 18 
CONFIDENTIAL 
 
 
to market or clinic by either Amgen or by distributors and partners for whom Amgen 
manufactures the material.  This includes drug(s) or device(s) provisioned and/or 
repackaged/modified by Amgen.  Drug(s) or device(s) includes investigational 
product. 
Section: 6.2  Product Complaints, Including Device Complaints, 4th paragraph 
Add: 
• 
misuse of the AI/pen or personal injector due to misunderstanding of the IFU or 
error on the part of the user, or other inability to appropriately use the product (eg, 
due to malfunction of the AI/Pen or personal injector) 
Section: 7.1.2.5  Quarterly Visits - All Subjects (Week 12, 24, 36, etc ± 7 Days) 
Add: 
• 
Blood draw for serum pregnancy (performed every 6 months for females of 
childbearing potential only) – Additional pregnancy testing may be performed at 
the discretion of the investigator 
Section: 7.1.2.6  End of Study (Week 260)/Early Term OL Visit – All Subjects, Title 
Add: 
End of Study (Week 260)/Early Term OL Visit – All Subjects 
Section: 9.1.2  Reporting Procedures for Adverse Events, 2nd paragraph 
Add: 
• 
Assessment of relatedness to investigational product (AMG 145) and/or any 
study-mandated activity and/or procedure, and 
Section: 9.1.2  Reporting Procedures for Adverse Events, 4th paragraph 
Replace: 
The investigator must assess whether the adverse event is possibly related to AMG 145.  
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 145 and/or other 
study drugs? 
With: 
The investigator must assess whether the adverse event is possibly related to IP 
(AMG 145).  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 145? 
Section: 9.3  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 protocol-required therapies and for an additional 15 weeks after the end 
of treatment with IP: AMG 145, report the pregnancy to Amgen as specified below. 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 8 of 18 
CONFIDENTIAL 
 
 
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 D).  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 a female subject is taking protocol-required therapies and 
for an additional 15 weeks after the end of treatment with IP (AMG 145) report the 
lactation case to Amgen as specified below.  
Any lactation case should be reported to Amgen’s global Lactation Surveillance Program 
(LSP) within 24 hours of the investigator’s knowledge of the event.  Report a lactation 
case on the Lactation Notification Worksheet (Appendix D). 
With: 
If a pregnancy occurs in a female subject, or a male subject fathers a child, while the 
subject is taking AMG 145 and for an additional 15 weeks after the last dose of 
AMG 145, report the pregnancy to Amgen as specified below. 
The pregnancy should be reported to Amgen’s 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 D).  Amgen’s Global Patient Safety will 
seek to obtain pregnancy and birth outcome information. 
If a lactation case occurs while a female subject is taking AMG 145 and for an additional 
15 weeks after the last dose of AMG 145, report the lactation case to Amgen as 
specified below.  
Any lactation case should be reported to Amgen’s Global Patient Safety within 24 hours 
of the investigator’s knowledge of the event.  Report a lactation case on the Lactation 
Notification Worksheet (Appendix D). 
Section: 10.4.1  General Approach/Considerations, 1st paragraph 
Add: 
Statistical analyses in this open label study are descriptive in nature.  No statistical 
inference or missing value imputation is planned.  The final analysis for the study will 
be performed at the end of the study (defined as when the last subject has 
completed the assessments for week 260 or until the investigator’s 
recommendation of discontinuation, Amgen’s recommendation of 
discontinuation, the subject’s decision to discontinue for any reason, or until an 
administrative decision is made to close the study). 
Section: Appendix A.  Schedule of Assessments, footnotes 
Add: 
Pregnancy testing will occur every 6 months and during screening.  Additional 
pregnancy testing may be performed at the discretion of the investigator. 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 9 of 18 
CONFIDENTIAL 
 
 
Section: Appendix B.  Additional Safety Assessment Information, Drug-induced Liver 
Injury Reporting & Additional Assessments 
Add: 
Reporting 
To facilitate appropriate monitoring for signals of DILI, cases of concurrent AST/ALT and 
TBL elevation according to the criteria specified in Section 6.1.3.2 (3x ULN for AST/ALT, 
2x ULN for TBL, and ALP < 2x ULN) require the following: 
Section: Appendix B.  Additional Safety Assessment Information, Drug-induced Liver 
Injury Reporting & Additional Assessments 
Replace: 
Additional Clinical Assessments and Observation 
• 
Repeat liver chemistries within 24-48 hours (ALT, AST, ALP, TBL); in cases of 
TBL > 2x ULN or AST/ALT much greater than 3x ULN, retesting should be 
performed within 24 hours  
With: 
Additional Clinical Assessments and Observation 
• 
Repeat liver chemistries within 24-48 hours (ALT, AST, ALP, TBL); in cases of 
TBL ≥ 2x ULN, ALP < 2x ULN, or AST/ALT much greater than 3x ULN, retesting 
should be performed within 24 hours  

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 10 of 18 
CONFIDENTIAL 
 
 
Section: Appendix C.  Sample Serious Adverse Event Report Form 
Replace: 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 11 of 18 
CONFIDENTIAL 
 
 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 12 of 18 
CONFIDENTIAL 
 
 
With: 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 13 of 18 
CONFIDENTIAL 
 
 
 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 14 of 18 
CONFIDENTIAL 
 
 
Section: Appendix D.  Pregnancy and Lacation Notification Worksheets 
Replace: 
 
 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 15 of 18 
CONFIDENTIAL 
 
 
 
 
 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 16 of 18 
CONFIDENTIAL 
 
 
With: 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 17 of 18 
CONFIDENTIAL 
 
 
 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  02 December 2015 
Page 18 of 18 
CONFIDENTIAL 
 
 
Section: Appendix E.  Tanner Staging (Sexual Maturity Ratings) 
Delete: 
MALES: 
Stage 
GENITAL SIZE 
PUBIC HAIR 
STAGING 
CONCOMITANT 
CHANGES 
PRADER 
ORCHIDOMETER 
1 
Prepubertal, papilla 
elevation 
No pigmented hair 
Long testis axis < 1.5 cm 
1 – 3 mL 
 

Product:  Evolocumab 
Protocol Number:  20110271 
Date:  11 May 2015 
Page 1 of 8 
CONFIDENTIAL 
 
 
Amendment 5 
Protocol Title:  A Multicenter, Open-label Study to Assess the Long-term Safety, 
Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects with Severe Familial 
Hypercholesterolemia 
 
Amgen Protocol Number 20110271 
EudraCT Number: 2011-005400-15 
 
 
Amendment Date: 
11 May 2015 
 
Rationale: 
This document provides the rationale and detailed list of changes for Amendment 5, 
dated 11 May 2015, from Amendment 4 of the study protocol, dated 15 April 2014. 
The purpose of this amendment is: 
1. To remove the external Data Monitoring Committee (DMC) following the DMC’s 
expressed preference to not review open-label, uncontrolled safety data. Safety 
monitoring will continue to be performed by AMGEN. Even though review of this 
specific study will no longer fall under direct DMC review, the DMC will continue 
to consider the totality of data from all studies.  Any emerging safety 
considerations identified by AMGEN will be discussed with the DMC and the 
committee will incorporate that data when making its recommendations to 
AMGEN.  Additional minor editorial and typographical changes were also made. 
2. To add measurements of height, weight and Tanner staging for adolescent 
subjects, and to allow for documentation of historical assessments of height, 
weight and Tanner staging in adolescent subjects.  A definition of ‘adolescent’ 
was also provided. 

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Product:  AMG 145 
Protocol Number:  20110271 
Date:  16 September 2013 
Page 1 of 54 
 
Amendment 3 
Title:  A Multicenter, Open-label Study to Assess the Long-term Safety, 
Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial 
Hypercholesterolemia 
AMG 145 
Amgen Protocol Number 20110271 
EudraCT Number: 2011-005400-15 
 
TAUSSIG 
 
Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL 
Disorders 
Amendment 3 Date: 
16 September 2013 
Rationale: 
This document provides the rationale and detailed list of changes for Amendment 3, 
dated 16 September 2013, from Amendment 2 of the study protocol, dated 07 December 
2012.  
The purpose of the amendment is to: 
• 
Add Lp(a) as a secondary endpoint 
• 
Update the exploratory endpoints  
• 
Include  subjects with severe hypercholesterolemia 
• 
Update the sample size to accommodate additional high need subjects 
• 
Exclude Lomitapide and CETP inhibitors  
• 
Add AI and AMD language  
• 
Clarify dose adjustment language 
• 
Update the safety reporting section with Amgen’s new template language  
• 
Add CEC language 
• 
Update the study schemas  
• 
Update the background section 
• 
Add addition criteria for withholding IP 
• 
Remove the apheresis substudy  
 

Product:  AMG 145 
Protocol Number:  20110271 
Date:  07 December 2012 
Page 1 of 27 
 
Amendment 2 
Title:  A Multicenter, Open-label Study to Assess the Long-term Safety, 
Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial 
Hypercholesterolemia 
AMG 145 
Amgen Protocol Number 20110271 
EudraCT Number: 2011-005400-15 
 
TAUSSIG 
 
Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL 
Disorders 
Amendment 2 Date: 
07 December 2012 
Rationale 
This document provides the rationale and detailed list of changes for Amendment 2, 
dated 07 December 2012, from Amendment 1 of the study protocol, dated 17 July 2012.  
The purpose of the amendment is to: 
• 
Update the at home dosing information 
• 
Change the dosing terminology from Q4W to QM 
• 
Add an additional secondary endpoint 
• 
Add more flexible dosing language for subjects that enter study 20110271 from study 
20110233 
• 
Highlight that lipid lowering concomitant medications cannot be adjusted during the 
first 12 weeks of the study 
 

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