REAL4: A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03811535

Collaborator

(none)

200

Enrollment

129

Locations

Arms

66.8

Anticipated Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study compares 2 medicines for children who do not have enough hormone to grow:

somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency in Children	Drug: Somapacitan Drug: Norditropin®	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will receive either somapacitan once weekly or Norditropin® once daily for 52 weeks (main trial period). All participants completing the main trial period will receive somapacitan weekly for 3 years (extension trial period).Participants will receive either somapacitan once weekly or Norditropin® once daily for 52 weeks (main trial period). All participants completing the main trial period will receive somapacitan weekly for 3 years (extension trial period).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

Actual Study Start Date :

May 20, 2019

Actual Primary Completion Date :

Nov 10, 2021

Anticipated Study Completion Date :

Dec 12, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Somapacitan weekly Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).	Drug: Somapacitan Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
Active Comparator: Norditropin® daily Participants will receive Norditropin® daily for 52 weeks (main trial period).	Drug: Norditropin® Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.

Arm

Intervention/Treatment

Experimental: Somapacitan weekly

Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).

Drug: Somapacitan

Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

Active Comparator: Norditropin® daily

Participants will receive Norditropin® daily for 52 weeks (main trial period).

Drug: Norditropin®

Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.

Outcome Measures

Primary Outcome Measures

Height velocity [Week 0-52]
Height velocity (HV) is measured in cm/year. HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).

Secondary Outcome Measures

Change in bone age [Week -2, Week 52]
Measured in years.
Change in Height Standard Deviation Score [Week 0, Week 52]
Measured in scores (-10 to +10). Height SDS will be derived using Centre for Disease Control and Prevention (CDC) standards.
Change in height velocity standard deviation score (HV SDS) [Week 0, Week 52]
Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.
Change in fasting plasma glucose (FPG): Week 52 [Week -2, Week 52]
Measured in mmol/L.
Change in FPG: Week 104 [Week -2, Week 104]
Measured in mmol/L.
Change in FPG: Week 156 [Week -2, Week 156]
Measured in mmol/L.
Change in FPG: Week 208 [Week -2, Week 208]
Measured in mmol/L.
Change in homeostatic model assessment (HOMA): Week 52 [Week -2, Week 52]
Measured in percentage.
Change in HOMA: Week 104 [Week -2, Week 104]
Measured in percentage.
Change in HOMA: Week 156 [Week -2, Week 156]
Measured in percentage.
Change in HOMA: Week 208 [Week -2, Week 208]
Measured in percentage.
Change in glycated haemoglobin (HbA1c): Week 52 [Week -2, Week 52]
Measured in percentage
Change in HbA1c: Week 104 [Week -2, Week 104]
Measured in percentage
Change in HbA1c: Week 156 [Week -2, Week 156]
Measured in percentage
Change in HbA1c: Week 208 [Week -2, Week 208]
Measured in percentage
Change in insulin-like growth factor I (IGF-I) SDS: Week 52 [Week 0, Week 52]
Measured in scores (-10 to +10).
Change in IGF-I SDS: Week 104 [Week 0, Week 104]
Measured in scores (-10 to +10).
Change in IGF-I SDS: Week 156 [Week 0, Week 156]
Measured in scores (-10 to +10).
Change in IGF-I SDS: Week 208 [Week 0, Week 208]
Measured in scores (-10 to +10).
Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS: Week 52 [Week 0, Week 52]
Measured in scores (-10 to +10).
Change in IGFBP-3 SDS: Week 104 [Week 0, Week 104]
Measured in scores (-10 to +10).
Change in IGFBP-3 SDS: Week 156 [Week 0, Week 156]
Measured in scores (-10 to +10).
Change in IGFBP-3 SDS: Week 208 [Week 0, Week 208]
Measured in scores (-10 to +10).

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard
Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
No prior exposure to growth hormone therapy or IGF-I treatment

Exclusion Criteria:

Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
Diagnosis of attention deficit hyperactivity disorder
Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
Prior history or presence of malignancy including intracranial tumours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35233
2	Novo Nordisk Investigational Site	Los Angeles	California	United States	90027
3	Novo Nordisk Investigational Site	Madera	California	United States	93636-8762
4	Novo Nordisk Investigational Site	Orange	California	United States	92868
5	Novo Nordisk Investigational Site	Sacramento	California	United States	95821
6	Novo Nordisk Investigational Site	Centennial	Colorado	United States	80112
7	Novo Nordisk Investigational Site	Greenwood Village	Colorado	United States	80111-2803
8	Novo Nordisk Investigational Site	New Haven	Connecticut	United States	06504
9	Novo Nordisk Investigational Site	Wilmington	Delaware	United States	19803
10	Novo Nordisk Investigational Site	Aventura	Florida	United States	33180
11	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30318
12	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46202
13	Novo Nordisk Investigational Site	Iowa City	Iowa	United States	52242
14	Novo Nordisk Investigational Site	Minneapolis	Minnesota	United States	55454
15	Novo Nordisk Investigational Site	Saint Paul	Minnesota	United States	55102
16	Novo Nordisk Investigational Site	Kansas City	Missouri	United States	64111
17	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89113
18	Novo Nordisk Investigational Site	Morristown	New Jersey	United States	07962
19	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
20	Novo Nordisk Investigational Site	Mineola	New York	United States	11501
21	Novo Nordisk Investigational Site	Raleigh	North Carolina	United States	27610
22	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45229
23	Novo Nordisk Investigational Site	Oklahoma City	Oklahoma	United States	73104
24	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
25	Novo Nordisk Investigational Site	Austin	Texas	United States	78723
26	Novo Nordisk Investigational Site	Fort Worth	Texas	United States	76104
27	Novo Nordisk Investigational Site	Tacoma	Washington	United States	98405
28	Novo Nordisk Investigational Site	Algiers		Algeria	16000
29	Novo Nordisk Investigational Site	Constantine		Algeria	25000
30	Novo Nordisk Investigational Site	Graz		Austria	8036
31	Novo Nordisk Investigational Site	Salzburg		Austria	A 5020
32	Novo Nordisk Investigational Site	St. Poelten		Austria	A 3100
33	Novo Nordisk Investigational Site	Vöcklabruck		Austria	A 4840
34	Novo Nordisk Investigational Site	Edmonton	Alberta	Canada	T6G 2B7
35	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H4A 3J1
36	Novo Nordisk Investigational Site	Copenhagen Ø		Denmark	2100
37	Novo Nordisk Investigational Site	Tallinn		Estonia	13419
38	Novo Nordisk Investigational Site	Tartu		Estonia	50406
39	Novo Nordisk Investigational Site	ANGERS cedex 09		France	49033
40	Novo Nordisk Investigational Site	Bordeaux Cedex		France	33076
41	Novo Nordisk Investigational Site	Le Kremlin-bicetre		France	94275
42	Novo Nordisk Investigational Site	MARSEILLE Cédex 05		France	13385
43	Novo Nordisk Investigational Site	Paris		France	75015
44	Novo Nordisk Investigational Site	Toulouse cedex 9		France	31059
45	Novo Nordisk Investigational Site	Frankfurt		Germany	60596
46	Novo Nordisk Investigational Site	Hannover		Germany	30159
47	Novo Nordisk Investigational Site	Tübingen		Germany	72076
48	Novo Nordisk Investigational Site	Ulm		Germany	89075
49	Novo Nordisk Investigational Site	Budapest		Hungary	1023
50	Novo Nordisk Investigational Site	Szeged		Hungary	6720
51	Novo Nordisk Investigational Site	Kochi	Kerala	India	682041
52	Novo Nordisk Investigational Site	Pune	Maharashtra	India	411001
53	Novo Nordisk Investigational Site	New Dehli	New Delhi	India	110029
54	Novo Nordisk Investigational Site	Dublin		Ireland	D12 N512
55	Novo Nordisk Investigational Site	Haifa		Israel	31096
56	Novo Nordisk Investigational Site	Kfar Saba		Israel	44281
57	Novo Nordisk Investigational Site	Petah Tikva		Israel	49202
58	Novo Nordisk Investigational Site	Zerifin		Israel	70300
59	Novo Nordisk Investigational Site	Firenze		Italy	50139
60	Novo Nordisk Investigational Site	Genova		Italy	16147
61	Novo Nordisk Investigational Site	Milano		Italy	20122
62	Novo Nordisk Investigational Site	Roma		Italy	00165
63	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka		Japan	813-0017
64	Novo Nordisk Investigational Site	Fukuoka		Japan	830-0011
65	Novo Nordisk Investigational Site	Fukuyama-shi, Hiroshima		Japan	720-8520
66	Novo Nordisk Investigational Site	Fukuyama-shi, Hiroshima		Japan	721-8511
67	Novo Nordisk Investigational Site	Kanagawa		Japan	232-8555
68	Novo Nordisk Investigational Site	Kobe-shi, Hyogo		Japan	650-0047
69	Novo Nordisk Investigational Site	Kyoto		Japan	602-8566
70	Novo Nordisk Investigational Site	Mito, Ibaraki		Japan	311-4145
71	Novo Nordisk Investigational Site	Nara-shi, Nara		Japan	630-8581
72	Novo Nordisk Investigational Site	Niigata-shi, Niigata		Japan	951 8520
73	Novo Nordisk Investigational Site	Obu-shi, Aichi		Japan	474-8710
74	Novo Nordisk Investigational Site	Okayama-shi, Okayama		Japan	701-1192
75	Novo Nordisk Investigational Site	Osaka		Japan	534-0021
76	Novo Nordisk Investigational Site	Osaka		Japan	594-1101
77	Novo Nordisk Investigational Site	Saitama-shi, Saitama		Japan	330-8777
78	Novo Nordisk Investigational Site	Shizuoka		Japan	431-3192
79	Novo Nordisk Investigational Site	Suita-shi, Osaka		Japan	565-0871
80	Novo Nordisk Investigational Site	Tokyo		Japan	113-8519
81	Novo Nordisk Investigational Site	Tokyo		Japan	144-0034
82	Novo Nordisk Investigational Site	Tokyo		Japan	157 8535
83	Novo Nordisk Investigational Site	Tokyo		Japan	158-0097
84	Novo Nordisk Investigational Site	Tokyo		Japan	160-8582
85	Novo Nordisk Investigational Site	Tokyo		Japan	183-8561
86	Novo Nordisk Investigational Site	Busan		Korea, Republic of	47392
87	Novo Nordisk Investigational Site	Daegu		Korea, Republic of	41944
88	Novo Nordisk Investigational Site	Gyeonggi-do		Korea, Republic of	13620
89	Novo Nordisk Investigational Site	Incheon		Korea, Republic of	22332
90	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	03080
91	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	03722
92	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	05355
93	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	05505
94	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	06351
95	Novo Nordisk Investigational Site	Suwon		Korea, Republic of	16499
96	Novo Nordisk Investigational Site	Riga		Latvia	LV1004
97	Novo Nordisk Investigational Site	Bergen		Norway	5021
98	Novo Nordisk Investigational Site	Szczecin		Poland	71-252
99	Novo Nordisk Investigational Site	Warszawa		Poland	04-730
100	Novo Nordisk Investigational Site	Izhevsk		Russian Federation	426009
101	Novo Nordisk Investigational Site	Moscow		Russian Federation	119435
102	Novo Nordisk Investigational Site	Moscow		Russian Federation	125373
103	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630048
104	Novo Nordisk Investigational Site	Rostov-on-Don		Russian Federation	344013
105	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	191144
106	Novo Nordisk Investigational Site	Samara		Russian Federation	443079
107	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
108	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
109	Novo Nordisk Investigational Site	Belgrade		Serbia	11070
110	Novo Nordisk Investigational Site	Kragujevac		Serbia	34000
111	Novo Nordisk Investigational Site	Nis		Serbia	18 000
112	Novo Nordisk Investigational Site	Novi Sad		Serbia	21000
113	Novo Nordisk Investigational Site	Ljubljana		Slovenia	1525
114	Novo Nordisk Investigational Site	Esplugues Llobregat(Barcelona)		Spain	08950
115	Novo Nordisk Investigational Site	Santiago de Compostela		Spain	15706
116	Novo Nordisk Investigational Site	Basel		Switzerland	4031
117	Novo Nordisk Investigational Site	Bern		Switzerland	3010
118	Novo Nordisk Investigational Site	Zürich		Switzerland	8032
119	Novo Nordisk Investigational Site	Bangkok		Thailand	10330
120	Novo Nordisk Investigational Site	Bangkok		Thailand	10400
121	Novo Nordisk Investigational Site	Kharkiv		Ukraine	61000
122	Novo Nordisk Investigational Site	Kyiv		Ukraine	04114
123	Novo Nordisk Investigational Site	Vinnytsia		Ukraine	21010
124	Novo Nordisk Investigational Site	Cambridge		United Kingdom	CB2 0QQ
125	Novo Nordisk Investigational Site	Hull		United Kingdom	HU3 2JZ
126	Novo Nordisk Investigational Site	Liverpool		United Kingdom	L12 2AP
127	Novo Nordisk Investigational Site	London		United Kingdom	E1 1BB
128	Novo Nordisk Investigational Site	Manchester		United Kingdom	M13 9WL
129	Novo Nordisk Investigational Site	Tooting		United Kingdom	SW17 0RE

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03811535

Other Study ID Numbers:

NN8640-4263
U1111-1207-9691
2018-000231-27
JapicCTI-194773

First Posted:

Jan 22, 2019

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dwarfism, Pituitary

Study Results

No Results Posted as of Feb 24, 2022