Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

Brief summary:
The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the long-term effects of eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).

Detailed description:
This is an open-label, multi-center study to evaluate the efficacy and safety of eteplirsen in patients with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to exon 51 skipping (treated group), with a concurrent control arm of DMD patients not amenable to exon 51 skipping (untreated group). Following primary efficacy endpoints, dosing will continue to week 144 to evaluate the long term effects of eteplirsen.

Patients in the treated group will receive once weekly intravenous (IV) infusions of 30 mg/kg Eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks). Patients in the untreated group will not receive treatment.

Clinical efficacy will be assessed at regularly scheduled study visits, including functional tests such as the six minute walk test. Patients in the treated group will undergo a muscle biopsy at Baseline and a second muscle biopsy over the course of the study. Patients in the untreated group will not undergo muscle biopsy.

Safety, including adverse event monitoring and routine laboratory assessments, will be continuously monitored for all patients.

Arms:
arm 1: Approximately 80 patients with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic deletions amenable to treatment by exon 51 skipping will receive 30 mg/kg of eteplirsen weekly for 96 weeks, followed by a safety extension (not to exceed 48 weeks). arm 2: Approximately 30 DMD patients not amenable to exon 51 skipping will not receive eteplirsen.

Interventions: intervention 1: eteplirsen
Intervention descriptions: intervention 1: Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks, followed by a safety extension (not to exceed 48 weeks).

Protocol document:
Prot_000.pdf: 
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Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 3 
 
02 June 2017 
 
 
INVESTIGATOR’S AGREEMENT 
I have read Protocol No. 4658-301 (Version 5, Amendment 4) and agree to conduct the study as 
outlined.  I agree to maintain the confidentiality of all information received or developed in 
connection with this protocol. 
 
 
 
 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 
 
 
 
Signature of Investigator 
 
 
 
 
 
Date 
 


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Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 18 
 
02 June 2017 
 
 
Table 3: 
Schedule of Events for Patients in the Treated Group - Week 49 Through  96, continued 
Assessments 
Treatment Period 
(2-day HS visits occur at Weeks 72 and 96) 
Study Period 
Week  
W49 
W52 
W56 
W60 
W64 
W68 
W72 
W76 
W80 
W84 
W88 
W92 
W96/ 
ETa 
i Procedure is only applicable for patients who qualify for the treated group and will occur at the surgical unit (SU).  Upon qualification for the study during the Baseline visit, patients in 
the treated group will be randomized to 1 of 4 biopsy groups according to this muscle biopsy schedule: 1) biopsy at Baseline and Week 24, 2) biopsy at Baseline and Week 48, 
3) biopsy at Baseline and Week 72, or 4) biopsy at Baseline and Week 96.  The biopsies at Weeks 24, 48, 72, and 96 must occur within 2 weeks after the specified visit, after the 
clinical evaluation, and at least 48 hours after the most recent infusion.  
j Eteplirsen will be administered by IV infusion.  Patients should be closely monitored for at least 1 hour following the completion of all infusions.  It is recommended that a topical 
anesthetic cream (e.g., lidocaine 2.5%, prilocaine 2.5% or LMX4 cream) be applied prior to infusions.  Optional in-home administration of eteplirsen by a visiting nurse may be 
available after Week 25 for visits where safety assessments are not being collected. 
 


Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 19 
 
02 June 2017 
 
 
Table 4: 
Schedule of Events for Patients in the Treated Group – Safety Extension (Week 97 through End of Study) 
Assessments 
Safety Extensiona 
End of Study 
Study Period 
Week  
Week 97 
W108 
W120 
W132 
W144 
W148/ETb 
Full physical examinationc 
 
 
X 
 
X 
X 
Vital signsd 
Weekly 
X 
Weight 
Every 4 weeks 
X 
Safety laboratory 
assessmentse 
 
 
X 
 
X 
X 
Eteplirsen infusionf 
Once Weekly ± 3 days  
(to be scheduled based on Week 1 infusion date) at Local Site 
 
Conmed/therapy 
Continuous 
AE assessment 
Continuous 
X = Local Site  
a Patients may continue in the safety extension for up to 48 weeks, until the product is commercially available or until they can transition into a separate eteplirsen 
study. 
b Early termination assessments are the same as Week 144 assessments.  
c Full physical examination: general appearance, head, eyes, ears, nose, and throat (HEENT), heart, chest, abdomen, skin, lymph nodes, extremities, musculoskeletal, 
and neurological systems.   
d Vital signs include blood pressure, heart rate, respiration, and oral temperature.  On infusion days, vital signs will be measured prior to infusion and approximately 
5 and 30 minutes after the end of the infusion.  If the patient has not experienced an infusion reaction after the first year of treatment, vital signs may be reduced to 
pre-infusion and 30 minutes after the end of the infusion. 
e Safety laboratory assessments include chemistry, hematology, coagulation, and urinalysis. 
f Eteplirsen will be administered by IV infusion.  Patients should be closely monitored for at least 1 hour following the completion of all infusions.  It is 
recommended that a topical anesthetic cream (e.g., lidocaine 2.5%, prilocaine 2.5% or LMX4 cream) be applied prior to infusions.  Patients who discontinue 
treatment with eteplirsen will have an End of Study visit (see W148 procedures) 4 weeks after their last infusion.  Optional in-home administration of eteplirsen by a 
visiting nurse may be available for visits where safety assessments are not being collected. 
 


Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 20 
 
02 June 2017 
 
 
Table 5: 
Schedule of Events for Untreated Control Patients - Screening Through End of Study 
Assessments 
Up to 10 weeks prior to Week 1a 
Observation Periodb 
(2-day HS visits occur at Weeks 12, 24, 36, 48, 72, and 96) 
Study Period 
Screening 
-10w up to -3w 
Baseline 
-4w to Day -1&-2 
Week  
1-day 
visit 
2-day 
visit 
2-day visit 
(3-5w after 
Screening at HS) 
W1c 
W4 
W8 
W12 
W24 
W36 
W48 
W72 
W96/ 
ETb 
Informed consent for screening 
at local site 
X 
 
 
 
 
 
 
 
 
 
 
 
Informed consent for screening 
at HS (if different from local 
site) 
 
HS 
 
 
 
 
 
 
 
 
 
 
Informed consent to participate 
as a control patient (no consent 
form needed at W12 if local is 
same as HS) 
 
 
 
X 
 
 
HS 
 
 
 
 
 
Assess inclusion/exclusion 
criteria 
X 
HS 
HS 
 
 
 
 
 
 
 
 
 
Confirm eligibilityd 
 
 
X 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
Full physical examinatione 
X 
 
 
X 
X 
 
X 
X 
X 
X 
X 
X 
Brief physical examinatione 
 
 
 
 
 
X 
 
 
 
 
 
 
Vital signsf 
X 
 
HS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Safety laboratory assessmentsg 
Xh 
 
 
Xh,i 
X 
X 
X 
X 
X 
X 
X 
X 


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Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 25 
 
02 June 2017 
 
 
9.6.2. 
Laboratory Assessments .............................................................................................48 
9.6.3. 
Randomization for Muscle Biopsy Schedule (Treated Group Only) .........................48 
9.7. 
Prior and Concomitant Medications and Therapeutic Procedures .............................48 
9.8. 
Treatment Compliance ................................................................................................49 
10. 
STUDY ASSESSMENTS ..........................................................................................50 
10.1. 
Study Schedule of Events ...........................................................................................50 
10.2. 
Study Assessments by Visit ........................................................................................50 
10.2.1. 
Screening Period (Up to 10 weeks prior to Week 1) ..................................................51 
10.2.2. 
Baseline Period (3-5 Weeks after Screening Functional Assessment Visit) ..............52 
10.2.3. 
Weekly Infusions (Weeks 1-96) (for the treated group only) .....................................53 
10.2.4. 
Additional Procedures for Week 1 .............................................................................54 
10.2.5. 
Additional Procedures for Week 4 .............................................................................54 
10.2.6. 
Additional Procedures for Week 8 .............................................................................54 
10.2.7. 
Additional Procedures for Weeks 12, 24, 36, 48, and 72 (Functional 
Assessment Visits) ......................................................................................................55 
10.2.8. 
Additional Procedures for Weeks 16, 32, 40, 44, 60, 84 (for the treated group 
only) ............................................................................................................................56 
10.2.9. 
Additional Procedures for Weeks 20, 28, 44, 52, 56, 64, 68, 76, 80, 88, 92 
(for the treated group only) .........................................................................................57 
10.2.10. 
Additional Procedures for Week 96 (or Early Termination Visit, if more than 
4 weeks after a Functional Assessment Visit) ............................................................57 
10.2.11. 
Safety Extension (Not to Exceed 48 Weeks) ..............................................................58 
10.2.12. 
Week 148 (End of Study Visit) ..................................................................................59 
10.3. 
Efficacy Assessments .................................................................................................59 
10.3.1. 
Primary Efficacy Assessment: 6-Minute Walk Test ..................................................59 
10.3.2. 
Secondary Efficacy Assessment .................................................................................59 
10.3.2.1. 
Muscle Biopsy (Treated Group Only) ........................................................................59 
10.3.2.2. 
North Star Ambulatory Assessment (NSAA) .............................................................60 


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CCI


Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 27 
 
02 June 2017 
 
 
11.3.3. 
Relationship to Underlying Disease ...........................................................................67 
11.3.4. 
Severity of Adverse Events ........................................................................................67 
11.3.5. 
Outcome ......................................................................................................................67 
11.3.6. 
Action Taken Regarding the Investigational Drug Product .......................................67 
11.3.7. 
Expectedness of an Adverse Event .............................................................................67 
11.3.8. 
Suspected Unexpected Serious Adverse Reactions (SUSAR) ...................................67 
11.4. 
Recording Adverse Events .........................................................................................68 
11.5. 
Reporting Serious Adverse Events .............................................................................68 
11.6. 
Special Situations ........................................................................................................68 
11.6.1. 
Overdose .....................................................................................................................68 
11.6.2. 
Death ...........................................................................................................................68 
11.6.3. 
Responsibilities of the Investigator ............................................................................69 
11.6.4. 
Responsibilities of the Sponsor ..................................................................................69 
12. 
DATA COLLECTION, QUALITY ASSURANCE, AND MANAGEMENT ..........70 
12.1. 
Recording of Data .......................................................................................................70 
12.2. 
Quality Assurance .......................................................................................................70 
12.3. 
Retention of Study Documents ...................................................................................70 
12.4. 
Termination of Study or Study Site ............................................................................71 
13. 
STATISTICAL METHODS AND PLANNED ANALYSES ...................................72 
13.1. 
General Considerations ...............................................................................................72 
13.2. 
Determination of Sample Size ....................................................................................72 
13.3. 
Analysis Sets ...............................................................................................................73 
13.4. 
Protocol Deviations ....................................................................................................73 
13.5. 
Disposition, Demographics, and Baseline Characteristics .........................................73 
13.6. 
Prior and Concomitant Medications and Physiotherapeutic Interventions .................74 
13.7. 
Medical History ..........................................................................................................74 
13.8. 
Dosing and Compliance ..............................................................................................74 


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Sarepta Therapeutics, Inc. 
Protocol 4658-301 
Version 5 (Amendment 4) 
Page 29 
 
02 June 2017 
 
 
14.5.1. 
Data .............................................................................................................................80 
14.5.2. 
Patient Anonymity ......................................................................................................80 
15. 
STUDY DOCUMENTATION AND GENERAL INFORMATION .........................81 
15.1. 
Essential Study Documents ........................................................................................81 
15.2. 
General Information ....................................................................................................81 
15.3. 
Dissemination of Study Results ..................................................................................81 
15.4. 
Product Handling and Complaints Reporting .............................................................82 
16. 
REFERENCES ...........................................................................................................83 
 
LIST OF TABLES 
Table 1: 
Emergency Contact Information ...................................................................................4 
Table 2: 
Schedule of Events for Patients in the Treated Group - Screening Through 
Week 48 ......................................................................................................................12 
Table 3: 
Schedule of Events for Patients in the Treated Group - Week 49 Through 
Week 96 ......................................................................................................................16 
Table 4: 
Schedule of Events for Patients in the Treated Group – Safety Extension 
(Week 97 through End of Study) ................................................................................19 
Table 5: 
Schedule of Events for Untreated Control Patients - Screening Through End 
of Study .......................................................................................................................20 
 
LIST OF FIGURES 
Figure 1: 
Overview of Study Design through Week 96 .............................................................38 
 


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