A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment
Phase: PHASE3
Conditions: Congenital Adrenal Hyperplasia
Sponsor: Neurocrine Biosciences

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
2

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
5

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
6

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
7

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
8

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
9

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
10

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
11

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
12

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
13

 
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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
14

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
15

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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30 November 2021
Confidential
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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
20

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
21

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
22

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
23

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
24

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
25

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
26

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
27

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
28

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
29

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
30

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
31

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
32

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30 November 2021
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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
37

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
38

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30 November 2021
Confidential
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30 November 2021
Confidential
41

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
42

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
44

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
45

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
46

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
47

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
48

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
49

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
50

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
51

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
52

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
53

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
55

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
56

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
57

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
58

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Confidential
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30 November 2021
Confidential
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Confidential
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30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
83

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
84

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
85

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
86

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
88

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
89

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
90

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
91

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
92

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
93

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
95

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
96

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
97

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
98

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
99

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Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
100

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Neurocrine Biosciences, Inc., Study No. NBI-74788-CAH3003 
Clinical Protocol Amendment No. 5 Final Version 
30 November 2021
Confidential
101