Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT03620747

Collaborator

Regeneron Pharmaceuticals (Industry)

397

Enrollment

132

Locations

Arm

41.7

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Dupilumab SAR231893 (REGN668)	Phase 3

Detailed Description

Duration per participant is until dupilumab approval for use in asthma and market availability to the patient, or a maximum of 144 weeks (ie, about 3 years) after the Start of Treatment (V1), whichever comes first.

Study Design

Study Type:

Interventional

Actual Enrollment :

397 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial

Actual Study Start Date :

Aug 30, 2018

Actual Primary Completion Date :

Feb 18, 2022

Actual Study Completion Date :

Feb 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dupilumab One dose administered every two weeks. A loading dose may be administered at the start of treatment for some patients (e.g., due to previous Dupilumab treatment discontinuation for more than 6 weeks).	Drug: Dupilumab SAR231893 (REGN668) Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

Arm

Intervention/Treatment

Experimental: Dupilumab

One dose administered every two weeks. A loading dose may be administered at the start of treatment for some patients (e.g., due to previous Dupilumab treatment discontinuation for more than 6 weeks).

Drug: Dupilumab SAR231893 (REGN668)

Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

Outcome Measures

Primary Outcome Measures

Treatment-emergent adverse events (TEAE) [Up to 3 years]
Percentage of patients reporting any TEAE
TEAE [Up to 3 years]
Event rates per 100 patient-years

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria :

Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.
Signed written informed consent.

Exclusion criteria:

Patients who experienced any systemic hypersensitivity reactions to the investigational medicinal product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Clinically significant comorbidity/lung disease other than asthma.
Patients with active autoimmune disease or patients who, as per Investigator's medical judgment, are suspected of having high risk for developing autoimmune disease.
History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number :840099	Gilbert	Arizona	United States	85234
2	Investigational Site Number :840087	Scottsdale	Arizona	United States	85248
3	Investigational Site Number :840402	Tucson	Arizona	United States	85721
4	Investigational Site Number :840132	Little Rock	Arkansas	United States	72209
5	Investigational Site Number :840121	San Jose	California	United States	95117
6	Investigational Site Number :840403	Denver	Colorado	United States	80206
7	Investigational Site Number :840130	Denver	Colorado	United States	80246
8	Investigational Site Number :840115	Ocoee	Florida	United States	34761
9	Investigational Site Number :840055	Sarasota	Florida	United States	34239
10	Investigational Site Number :840079	Twin Falls	Idaho	United States	83301
11	Investigational Site Number :840032	Fort Mitchell	Kentucky	United States	41017
12	Investigational Site Number :840064	Bangor	Maine	United States	04401
13	Investigational Site Number :840052	Chevy Chase	Maryland	United States	20815
14	Investigational Site Number :840073	Gaithersburg	Maryland	United States	20878
15	Investigational Site Number :840018	Minneapolis	Minnesota	United States	55402
16	Investigational Site Number :840102	Saint Louis	Missouri	United States	63141
17	Investigational Site Number :840004	Papillion	Nebraska	United States	27103
18	Investigational Site Number :840068	West Long Branch	New Jersey	United States	07764
19	Investigational Site Number :840126	Charlotte	North Carolina	United States	28277
20	Investigational Site Number :840907	High Point	North Carolina	United States	27262
21	Investigational Site Number :840942	Toledo	Ohio	United States	43617
22	Investigational Site Number :840067	Philadelphia	Pennsylvania	United States	19140
23	Investigational Site Number :840091	Pittsburgh	Pennsylvania	United States	15241
24	Investigational Site Number :840070	Allen	Texas	United States	75013
25	Investigational Site Number :840062	Amarillo	Texas	United States	79109
26	Investigational Site Number :840124	Cypress	Texas	United States	77429
27	Investigational Site Number :840023	Dallas	Texas	United States	75231
28	Investigational Site Number :840922	Fort Worth	Texas	United States	76109
29	Investigational Site Number :840027	Fort Worth	Texas	United States	76244
30	Investigational Site Number :840008	San Antonio	Texas	United States	78229
31	Investigational Site Number :840035	Draper	Utah	United States	84020
32	Investigational Site Number :840077	Murray	Utah	United States	84107
33	Investigational Site Number :840057	South Burlington	Vermont	United States	05403
34	Investigational Site Number :840059	Fairfax	Virginia	United States	22030
35	Investigational Site Number :840951	Bellingham	Washington	United States	98225
36	Investigational Site Number :032096	Bahia Blanca	Buenos Aires	Argentina	B8000JRB
37	Investigational Site Number :032091	Capital Federal	Buenos Aires	Argentina	C1426ABP
38	Investigational Site Number :032002	La Plata	Buenos Aires	Argentina	B1900BNN
39	Investigational Site Number :032006	Rosario	Santa Fe	Argentina	S2000BRH
40	Investigational Site Number :032005	Rosario	Santa Fe	Argentina	S2000JKR
41	Investigational Site Number :032004	Buenos Aires		Argentina	2317
42	Investigational Site Number :032003	Ciudad Autonoma Bs As		Argentina	C1121ABE
43	Investigational Site Number :032097	Ciudad Autonoma Buenos Aires		Argentina	C1414AIF
44	Investigational Site Number :032010	Ciudad Autonoma Buenos Aires		Argentina	C1414CGA
45	Investigational Site Number :032001	Ciudad Autonoma Buenos Aires		Argentina	C1425BEN
46	Investigational Site Number :032012	San Miguel de Tucuman		Argentina	T4000CHE
47	Investigational Site Number :032009	San Miguel De TucumÃ¡n		Argentina	4000
48	Investigational Site Number :056003	Gent		Belgium	9000
49	Investigational Site Number :124006	Vancouver	British Columbia	Canada	V5Z 1M9
50	Investigational Site Number :124017	Vancouver	British Columbia	Canada	V6Z 1Y6
51	Investigational Site Number :124016	Hamilton	Ontario	Canada	L8N 4A6
52	Investigational Site Number :124013	Ottawa	Ontario	Canada	K1G 6C6
53	Investigational Site Number :124002	Toronto	Ontario	Canada	M5T 3A9
54	Investigational Site Number :124001	Montreal	Quebec	Canada	H2X 1P1
55	Investigational Site Number :124012	Montreal	Quebec	Canada	H3G 1A4
56	Investigational Site Number :124010	MontrÃ©al	Quebec	Canada	H4J 1C5
57	Investigational Site Number :124014	QuÃ©bec	Quebec	Canada	G1V 4W2
58	Investigational Site Number :124007	Trois-Rivieres	Quebec	Canada	G8T 7A1
59	Investigational Site Number :124018	Quebec		Canada	G1V 4G5
60	Investigational Site Number :250009	Brest cedex 2		France	29609
61	Investigational Site Number :250010	Lille Cedex		France	59037
62	Investigational Site Number :250006	Lyon cedex 04		France	69317
63	Investigational Site Number :250001	Marseille		France	13015
64	Investigational Site Number :250002	Montpellier cedex 5		France	34295
65	Investigational Site Number :250005	Nantes cedex		France	44093
66	Investigational Site Number :250008	Strasbourg		France	67091
67	Investigational Site Number :276006	Berlin		Germany	10787
68	Investigational Site Number :276010	Frankfurt am Main		Germany	60596
69	Investigational Site Number :276011	Grosshansdorf		Germany	22927
70	Investigational Site Number :276009	Koblenz		Germany	56068
71	Investigational Site Number :276005	Ruedersdorf		Germany	15562
72	Investigational Site Number :376001	Kfar- Sava		Israel	4428164
73	Investigational Site Number :376005	Petach-Tikva		Israel	4941492
74	Investigational Site Number :376002	Rehovot		Israel	76100
75	Investigational Site Number :392106	Mizunami-shi	Gifu	Japan	509-6134
76	Investigational Site Number :392043	Ota-shi	Gunma	Japan	373-0807
77	Investigational Site Number :392021	Fukuyama-shi	Hiroshima	Japan	720-0001
78	Investigational Site Number :392108	Hiroshima-shi	Hiroshima	Japan	734-8530
79	Investigational Site Number :392164	Muroran-shi	Hokkaido	Japan	0143-0076
80	Investigational Site Number :392008	Sapporo-shi	Hokkaido	Japan	062-8618
81	Investigational Site Number :392034	Sapporo-shi	Hokkaido	Japan	064-0804
82	Investigational Site Number :392006	Tomakomai-shi	Hokkaido	Japan	053-8506
83	Investigational Site Number :392162	Kobe-shi	Hyogo	Japan	650-0017
84	Investigational Site Number :392020	Naka-gun	Ibaraki	Japan	319-1113
85	Investigational Site Number :392011	Sakaide-shi	Kagawa	Japan	762-8550
86	Investigational Site Number :392014	Yokohama-shi	Kanagawa	Japan	231-8682
87	Investigational Site Number :392153	Kyoto-shi	Kyoto	Japan	615-8087
88	Investigational Site Number :392170	Osaki-shi	Miyagi	Japan	989-6183
89	Investigational Site Number :392045	Uruma-shi	Okinawa	Japan	904-2293
90	Investigational Site Number :392119	Kishiwada-shi	Osaka	Japan	596-8501
91	Investigational Site Number :392005	Naruto-shi	Tokushima	Japan	772-0017
92	Investigational Site Number :392002	Chuo-ku	Tokyo	Japan	103-0028
93	Investigational Site Number :392112	Chuo-ku	Tokyo	Japan	104-0031
94	Investigational Site Number :392133	Machida-shi	Tokyo	Japan	194-0023
95	Investigational Site Number :392177	Ome-shi	Tokyo	Japan	198-0042
96	Investigational Site Number :392038	Setagaya-ku	Tokyo	Japan	158-0097
97	Investigational Site Number :392167	Shinagawa-ku	Tokyo	Japan	142-8666
98	Investigational Site Number :392173	Tachikawa-shi	Tokyo	Japan	190-0012
99	Investigational Site Number :392185	Akashi-shi		Japan	674-0063
100	Investigational Site Number :392007	Chuo-Ku		Japan	103-0027
101	Investigational Site Number :392012	Edogawa-ku		Japan	134-0083
102	Investigational Site Number :392030	Habikino-shi		Japan	583-8588
103	Investigational Site Number :392004	Himeji-shi		Japan	672-8064
104	Investigational Site Number :392158	Hiroshima-shi		Japan	732-0052
105	Investigational Site Number :392013	Iizuka-shi		Japan	820-8505
106	Investigational Site Number :392042	Isesaki-shi		Japan	372-0831
107	Investigational Site Number :392142	Kasuga-shi		Japan	816-0813
108	Investigational Site Number :392040	Kodaira-shi		Japan	187-0024
109	Investigational Site Number :392044	Kokubunji-shi		Japan	185-0014
110	Investigational Site Number :392010	Kurashiki-shi		Japan	712-8064
111	Investigational Site Number :392036	Kyoto-shi		Japan	612-0026
112	Investigational Site Number :392144	Minato-ku		Japan	105-0003
113	Investigational Site Number :392122	Minato-ku		Japan	108-8606
114	Investigational Site Number :392163	Nagoya-shi		Japan	454-8509
115	Investigational Site Number :392155	Osakasayama-shi		Japan	589-0022
116	Investigational Site Number :392152	Osakasayama-shi		Japan	589-8511
117	Investigational Site Number :392127	Ota-ku		Japan	145-0071
118	Investigational Site Number :392169	Sagamihara-shi		Japan	252-0392
119	Investigational Site Number :392130	Shinjuku-ku		Japan	162-8655
120	Investigational Site Number :392165	Sumida-ku		Japan	130-8587
121	Investigational Site Number :392146	Tachikawa-shi		Japan	190-0014
122	Investigational Site Number :392029	Tsu-shi		Japan	514-0125
123	Investigational Site Number :392168	Uozu-shi		Japan	937-0042
124	Investigational Site Number :392132	Urasoe-shi		Japan	901-2121
125	Investigational Site Number :528001	Arnhem		Netherlands	6815 AD
126	Investigational Site Number :710009	Brandfort		South Africa	9400
127	Investigational Site Number :710011	Cape Town		South Africa	7505
128	Investigational Site Number :710001	Cape Town		South Africa	7531
129	Investigational Site Number :710091	Cape Town		South Africa	7700
130	Investigational Site Number :710092	Cape Town		South Africa	7700
131	Investigational Site Number :710006	Durban		South Africa	4071
132	Investigational Site Number :710007	Pretoria		South Africa	0087

Sponsors and Collaborators

Sanofi
Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT03620747

Other Study ID Numbers:

LPS15023
2017-002134-23
U1111-1196-5369

First Posted:

Aug 8, 2018

Last Update Posted:

May 4, 2022

Last Verified:

Apr 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:

Asthma

Study Results

No Results Posted as of May 4, 2022