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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dupilumab SAR231893 (REGN668)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational Site Number :840099
  • Investigational Site Number :840087
  • Investigational Site Number :840402
  • Investigational Site Number :840132
  • Investigational Site Number :840121
  • Investigational Site Number :840403
  • Investigational Site Number :840130
  • Investigational Site Number :840115
  • Investigational Site Number :840055
  • Investigational Site Number :840079
  • Investigational Site Number :840032
  • Investigational Site Number :840064
  • Investigational Site Number :840052
  • Investigational Site Number :840073
  • Investigational Site Number :840018
  • Investigational Site Number :840102
  • Investigational Site Number :840004
  • Investigational Site Number :840068
  • Investigational Site Number :840126
  • Investigational Site Number :840907
  • Investigational Site Number :840942
  • Investigational Site Number :840067
  • Investigational Site Number :840091
  • Investigational Site Number :840070
  • Investigational Site Number :840062
  • Investigational Site Number :840124
  • Investigational Site Number :840023
  • Investigational Site Number :840922
  • Investigational Site Number :840027
  • Investigational Site Number :840008
  • Investigational Site Number :840035
  • Investigational Site Number :840077
  • Investigational Site Number :840057
  • Investigational Site Number :840059
  • Investigational Site Number :840951
  • Investigational Site Number :032096
  • Investigational Site Number :032091
  • Investigational Site Number :032002
  • Investigational Site Number :032006
  • Investigational Site Number :032005
  • Investigational Site Number :032004
  • Investigational Site Number :032003
  • Investigational Site Number :032097
  • Investigational Site Number :032010
  • Investigational Site Number :032001
  • Investigational Site Number :032012
  • Investigational Site Number :032009
  • Investigational Site Number :056003
  • Investigational Site Number :124006
  • Investigational Site Number :124017
  • Investigational Site Number :124016
  • Investigational Site Number :124013
  • Investigational Site Number :124002
  • Investigational Site Number :124001
  • Investigational Site Number :124012
  • Investigational Site Number :124010
  • Investigational Site Number :124014
  • Investigational Site Number :124007
  • Investigational Site Number :124018
  • Investigational Site Number :250009
  • Investigational Site Number :250010
  • Investigational Site Number :250006
  • Investigational Site Number :250001
  • Investigational Site Number :250002
  • Investigational Site Number :250005
  • Investigational Site Number :250008
  • Investigational Site Number :276006
  • Investigational Site Number :276010
  • Investigational Site Number :276011
  • Investigational Site Number :276009
  • Investigational Site Number :276005
  • Investigational Site Number :376001
  • Investigational Site Number :376005
  • Investigational Site Number :376002
  • Investigational Site Number :392106
  • Investigational Site Number :392043
  • Investigational Site Number :392021
  • Investigational Site Number :392108
  • Investigational Site Number :392164
  • Investigational Site Number :392008
  • Investigational Site Number :392034
  • Investigational Site Number :392006
  • Investigational Site Number :392162
  • Investigational Site Number :392020
  • Investigational Site Number :392011
  • Investigational Site Number :392014
  • Investigational Site Number :392153
  • Investigational Site Number :392170
  • Investigational Site Number :392045
  • Investigational Site Number :392119
  • Investigational Site Number :392005
  • Investigational Site Number :392002
  • Investigational Site Number :392112
  • Investigational Site Number :392133
  • Investigational Site Number :392177
  • Investigational Site Number :392038
  • Investigational Site Number :392167
  • Investigational Site Number :392173
  • Investigational Site Number :392185
  • Investigational Site Number :392007
  • Investigational Site Number :392012
  • Investigational Site Number :392030
  • Investigational Site Number :392004
  • Investigational Site Number :392158
  • Investigational Site Number :392013
  • Investigational Site Number :392042
  • Investigational Site Number :392142
  • Investigational Site Number :392040
  • Investigational Site Number :392044
  • Investigational Site Number :392010
  • Investigational Site Number :392036
  • Investigational Site Number :392144
  • Investigational Site Number :392122
  • Investigational Site Number :392163
  • Investigational Site Number :392155
  • Investigational Site Number :392152
  • Investigational Site Number :392127
  • Investigational Site Number :392169
  • Investigational Site Number :392130
  • Investigational Site Number :392165
  • Investigational Site Number :392146
  • Investigational Site Number :392029
  • Investigational Site Number :392168
  • Investigational Site Number :392132
  • Investigational Site Number :528001
  • Investigational Site Number :710009
  • Investigational Site Number :710011
  • Investigational Site Number :710001
  • Investigational Site Number :710091
  • Investigational Site Number :710092
  • Investigational Site Number :710006
  • Investigational Site Number :710007

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupilumab

Arm Description

Participants received subcutaneous (SC) dose of dupilumab 300 milligrams (mg) every 2 weeks (q2w) from Week 0 up to Week 132. Participants who discontinued treatment for greater than or equal to (>=) 6 weeks after study LTS12551 (NCT02134028), received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose inhaled corticosteroid (ICS) as maintained in study LTS12551 in combination with controllers (and/or oral corticosteroid [OCS] for those participants from the original parent study EFC13691 [NCT02528214]). Salbutamol/albuterol hydrofluoroalkane pressurized metered dose inhalers (MDI) or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product [IMP] up to 12 weeks after the last dose of the IMP).
Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years)
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the IMP up to 12 weeks after last dose of the IMP). TEAE event rate was defined as the number of TEAE events per 100 participant-years.

Secondary Outcome Measures

Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. AESIs were AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. AESI event rate was defined as the number of AESI events per 100 participant-years.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation
AE: any untoward medical occurrence in participants that received IMP and did not necessarily had to have causal relationship with treatment. TEAEs: AEs developed/worsened in grade/become serious during the TEAE period (from first dose of IMP up to 12 weeks after last dose of IMP).SAE: any untoward medical occurrence at any dose resulted in death, was life-threatening, required inpatient hospitalization, prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically important event. AESI: AE (serious/non-serious) of scientific and medical concern specific to Sponsor's product/program, for which ongoing monitoring and immediate notification by Investigator to Sponsor required.

Full Information

First Posted
July 26, 2018
Last Updated
February 17, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03620747
Brief Title
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).
Detailed Description
Duration per participant was until dupilumab approval for use in asthma and market availability to the participant, or a maximum of 144 weeks (i.e., about 3 years) after the start of treatment (Visit 1), whichever came first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab
Arm Type
Experimental
Arm Description
Participants received subcutaneous (SC) dose of dupilumab 300 milligrams (mg) every 2 weeks (q2w) from Week 0 up to Week 132. Participants who discontinued treatment for greater than or equal to (>=) 6 weeks after study LTS12551 (NCT02134028), received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose inhaled corticosteroid (ICS) as maintained in study LTS12551 in combination with controllers (and/or oral corticosteroid [OCS] for those participants from the original parent study EFC13691 [NCT02528214]). Salbutamol/albuterol hydrofluoroalkane pressurized metered dose inhalers (MDI) or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.
Intervention Type
Drug
Intervention Name(s)
Dupilumab SAR231893 (REGN668)
Intervention Description
Pharmaceutical form: prefilled syringes Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product [IMP] up to 12 weeks after the last dose of the IMP).
Time Frame
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Title
Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years)
Description
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the IMP up to 12 weeks after last dose of the IMP). TEAE event rate was defined as the number of TEAE events per 100 participant-years.
Time Frame
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Secondary Outcome Measure Information:
Title
Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years)
Description
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. AESIs were AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. AESI event rate was defined as the number of AESI events per 100 participant-years.
Time Frame
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
Title
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation
Description
AE: any untoward medical occurrence in participants that received IMP and did not necessarily had to have causal relationship with treatment. TEAEs: AEs developed/worsened in grade/become serious during the TEAE period (from first dose of IMP up to 12 weeks after last dose of IMP).SAE: any untoward medical occurrence at any dose resulted in death, was life-threatening, required inpatient hospitalization, prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically important event. AESI: AE (serious/non-serious) of scientific and medical concern specific to Sponsor's product/program, for which ongoing monitoring and immediate notification by Investigator to Sponsor required.
Time Frame
From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551. Signed written informed consent. Exclusion criteria: Participants who experienced any systemic hypersensitivity reactions to the investigational medicinal product in the previous dupilumab asthma study LTS12551, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab might present an unreasonable risk for the participant. Clinically significant comorbidity/lung disease other than asthma. Participants with active autoimmune disease or participants who, as per Investigator's medical judgment, were 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 non-metastatic squamous or basal cell carcinoma of the skin. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :840099
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Investigational Site Number :840087
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85248
Country
United States
Facility Name
Investigational Site Number :840402
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Facility Name
Investigational Site Number :840132
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Investigational Site Number :840121
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Investigational Site Number :840403
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Investigational Site Number :840130
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Investigational Site Number :840115
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Investigational Site Number :840055
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigational Site Number :840079
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Investigational Site Number :840032
City
Fort Mitchell
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Investigational Site Number :840064
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Investigational Site Number :840052
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Investigational Site Number :840073
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20878
Country
United States
Facility Name
Investigational Site Number :840018
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Investigational Site Number :840102
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Site Number :840004
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site Number :840068
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Investigational Site Number :840126
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Investigational Site Number :840907
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigational Site Number :840942
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Investigational Site Number :840067
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Investigational Site Number :840091
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Investigational Site Number :840070
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Investigational Site Number :840062
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
Investigational Site Number :840124
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Investigational Site Number :840023
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number :840922
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
Investigational Site Number :840027
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76244
Country
United States
Facility Name
Investigational Site Number :840008
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number :840035
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Investigational Site Number :840077
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Investigational Site Number :840057
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Investigational Site Number :840059
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Investigational Site Number :840951
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Investigational Site Number :032096
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
B8000JRB
Country
Argentina
Facility Name
Investigational Site Number :032091
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Investigational Site Number :032002
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900BNN
Country
Argentina
Facility Name
Investigational Site Number :032006
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BRH
Country
Argentina
Facility Name
Investigational Site Number :032005
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Facility Name
Investigational Site Number :032004
City
Buenos Aires
ZIP/Postal Code
2317
Country
Argentina
Facility Name
Investigational Site Number :032003
City
Ciudad Autonoma Bs As
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Investigational Site Number :032097
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Investigational Site Number :032010
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1414CGA
Country
Argentina
Facility Name
Investigational Site Number :032001
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Investigational Site Number :032012
City
San Miguel de Tucuman
ZIP/Postal Code
T4000CHE
Country
Argentina
Facility Name
Investigational Site Number :032009
City
San Miguel De Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Investigational Site Number :056003
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number :124006
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Investigational Site Number :124017
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Investigational Site Number :124016
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Investigational Site Number :124013
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Facility Name
Investigational Site Number :124002
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Investigational Site Number :124001
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
Investigational Site Number :124012
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Investigational Site Number :124010
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Investigational Site Number :124014
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Investigational Site Number :124007
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Investigational Site Number :124018
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Investigational Site Number :250009
City
Brest cedex 2
ZIP/Postal Code
29609
Country
France
Facility Name
Investigational Site Number :250010
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number :250006
City
Lyon cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Investigational Site Number :250001
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Investigational Site Number :250002
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number :250005
City
Nantes cedex
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :250008
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Investigational Site Number :276006
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Investigational Site Number :276010
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Investigational Site Number :276011
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Investigational Site Number :276009
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Investigational Site Number :276005
City
Ruedersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Investigational Site Number :376001
City
Kfar- Sava
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Investigational Site Number :376005
City
Petach-Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Investigational Site Number :376002
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Investigational Site Number :392106
City
Mizunami-shi
State/Province
Gifu
ZIP/Postal Code
509-6134
Country
Japan
Facility Name
Investigational Site Number :392043
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-0807
Country
Japan
Facility Name
Investigational Site Number :392021
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Investigational Site Number :392108
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Investigational Site Number :392164
City
Muroran-shi
State/Province
Hokkaido
ZIP/Postal Code
0143-0076
Country
Japan
Facility Name
Investigational Site Number :392008
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
062-8618
Country
Japan
Facility Name
Investigational Site Number :392034
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Investigational Site Number :392006
City
Tomakomai-shi
State/Province
Hokkaido
ZIP/Postal Code
053-8506
Country
Japan
Facility Name
Investigational Site Number :392162
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Investigational Site Number :392020
City
Naka-gun
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Investigational Site Number :392011
City
Sakaide-shi
State/Province
Kagawa
ZIP/Postal Code
762-8550
Country
Japan
Facility Name
Investigational Site Number :392014
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Investigational Site Number :392153
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
615-8087
Country
Japan
Facility Name
Investigational Site Number :392170
City
Osaki-shi
State/Province
Miyagi
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
Investigational Site Number :392045
City
Uruma-shi
State/Province
Okinawa
ZIP/Postal Code
904-2293
Country
Japan
Facility Name
Investigational Site Number :392119
City
Kishiwada-shi
State/Province
Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Investigational Site Number :392005
City
Naruto-shi
State/Province
Tokushima
ZIP/Postal Code
772-0017
Country
Japan
Facility Name
Investigational Site Number :392002
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Investigational Site Number :392112
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Investigational Site Number :392133
City
Machida-shi
State/Province
Tokyo
ZIP/Postal Code
194-0023
Country
Japan
Facility Name
Investigational Site Number :392177
City
Ome-shi
State/Province
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Facility Name
Investigational Site Number :392038
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Investigational Site Number :392167
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Investigational Site Number :392173
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0012
Country
Japan
Facility Name
Investigational Site Number :392185
City
Akashi-shi
ZIP/Postal Code
674-0063
Country
Japan
Facility Name
Investigational Site Number :392007
City
Chuo-Ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Investigational Site Number :392012
City
Edogawa-ku
ZIP/Postal Code
134-0083
Country
Japan
Facility Name
Investigational Site Number :392030
City
Habikino-shi
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Investigational Site Number :392004
City
Himeji-shi
ZIP/Postal Code
672-8064
Country
Japan
Facility Name
Investigational Site Number :392158
City
Hiroshima-shi
ZIP/Postal Code
732-0052
Country
Japan
Facility Name
Investigational Site Number :392013
City
Iizuka-shi
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Investigational Site Number :392042
City
Isesaki-shi
ZIP/Postal Code
372-0831
Country
Japan
Facility Name
Investigational Site Number :392142
City
Kasuga-shi
ZIP/Postal Code
816-0813
Country
Japan
Facility Name
Investigational Site Number :392040
City
Kodaira-shi
ZIP/Postal Code
187-0024
Country
Japan
Facility Name
Investigational Site Number :392044
City
Kokubunji-shi
ZIP/Postal Code
185-0014
Country
Japan
Facility Name
Investigational Site Number :392010
City
Kurashiki-shi
ZIP/Postal Code
712-8064
Country
Japan
Facility Name
Investigational Site Number :392036
City
Kyoto-shi
ZIP/Postal Code
612-0026
Country
Japan
Facility Name
Investigational Site Number :392144
City
Minato-ku
ZIP/Postal Code
105-0003
Country
Japan
Facility Name
Investigational Site Number :392122
City
Minato-ku
ZIP/Postal Code
108-8606
Country
Japan
Facility Name
Investigational Site Number :392163
City
Nagoya-shi
ZIP/Postal Code
454-8509
Country
Japan
Facility Name
Investigational Site Number :392155
City
Osakasayama-shi
ZIP/Postal Code
589-0022
Country
Japan
Facility Name
Investigational Site Number :392152
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Investigational Site Number :392127
City
Ota-ku
ZIP/Postal Code
145-0071
Country
Japan
Facility Name
Investigational Site Number :392169
City
Sagamihara-shi
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Investigational Site Number :392130
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Investigational Site Number :392165
City
Sumida-ku
ZIP/Postal Code
130-8587
Country
Japan
Facility Name
Investigational Site Number :392146
City
Tachikawa-shi
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Investigational Site Number :392029
City
Tsu-shi
ZIP/Postal Code
514-0125
Country
Japan
Facility Name
Investigational Site Number :392168
City
Uozu-shi
ZIP/Postal Code
937-0042
Country
Japan
Facility Name
Investigational Site Number :392132
City
Urasoe-shi
ZIP/Postal Code
901-2121
Country
Japan
Facility Name
Investigational Site Number :528001
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Investigational Site Number :710009
City
Brandfort
ZIP/Postal Code
9400
Country
South Africa
Facility Name
Investigational Site Number :710011
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Investigational Site Number :710001
City
Cape Town
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Investigational Site Number :710091
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Investigational Site Number :710092
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Investigational Site Number :710006
City
Durban
ZIP/Postal Code
4071
Country
South Africa
Facility Name
Investigational Site Number :710007
City
Pretoria
ZIP/Postal Code
0087
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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