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

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

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).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Dupilumab SAR231893 (REGN668)

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.

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dupilumab; 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.

Drug: Dupilumab SAR231893 (REGN668); Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
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.	From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)
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.	From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: LPS15023; 2017-002134-23 (EudraCT Number); U1111-1196-5369 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No