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AsthmaPhase 3NCT03620747

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

A Phase 3 study testing Dupilumab SAR231893 (REGN668) in people with Asthma, run by Sanofi at 132 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab SAR231893 (REGN668)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
393 participants
Where
132 sitesin 10 countries
Study dates
30 Aug 2018to 18 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

132 sites in 10 countries.

132 sites in 10 countries

Japan50 sites

  • Investigational Site Number :392185

    Akashi-shi, 674-0063

  • Investigational Site Number :392002

    Chuo-ku, Tokyo, 103-0028

  • Investigational Site Number :392112

    Chuo-ku, Tokyo, 104-0031

  • Investigational Site Number :392007

    Chūōku, 103-0027

  • Investigational Site Number :392012

    Edogawa-ku, 134-0083

  • Investigational Site Number :392021

    Fukuyama-shi, Hiroshima, 720-0001

  • Investigational Site Number :392030

    Habikino-shi, 583-8588

  • Investigational Site Number :392004

    Himeji-shi, 672-8064

  • Investigational Site Number :392108

    Hiroshima, Hiroshima, 734-8530

  • Investigational Site Number :392158

    Hiroshima, 732-0052

  • Investigational Site Number :392013

    Iizuka-shi, 820-8505

  • Investigational Site Number :392042

    Isesaki-shi, 372-0831

  • Investigational Site Number :392142

    Kasuga-shi, 816-0813

  • Investigational Site Number :392119

    Kishiwada-shi, Osaka, 596-8501

  • Investigational Site Number :392162

    Kobe, Hyōgo, 650-0017

  • Investigational Site Number :392040

    Kodaira-shi, 187-0024

  • Investigational Site Number :392044

    Kokubunji-shi, 185-0014

  • Investigational Site Number :392010

    Kurashiki-shi, 712-8064

  • Investigational Site Number :392153

    Kyoto, Kyoto, 615-8087

  • Investigational Site Number :392036

    Kyoto, 612-0026

  • Investigational Site Number :392133

    Machida-shi, Tokyo, 194-0023

  • Investigational Site Number :392144

    Minatoku, 105-0003

  • Investigational Site Number :392122

    Minatoku, 108-8606

  • Investigational Site Number :392106

    Mizunami-shi, Gifu, 509-6134

  • Investigational Site Number :392164

    Muroran-shi, Hokkaido, 0143-0076

  • Investigational Site Number :392163

    Nagoya, 454-8509

  • Investigational Site Number :392020

    Naka-gun, Ibaraki, 319-1113

  • Investigational Site Number :392005

    Naruto-shi, Tokushima, 772-0017

  • Investigational Site Number :392177

    Ome-shi, Tokyo, 198-0042

  • Investigational Site Number :392155

    Osakasayama-shi, 589-0022

  • Investigational Site Number :392152

    Osakasayama-shi, 589-8511

  • Investigational Site Number :392170

    Osaki-shi, Miyagi, 989-6183

  • Investigational Site Number :392127

    Ōta-ku, 145-0071

  • Investigational Site Number :392043

    Ota-shi, Gunma, 373-0807

  • Investigational Site Number :392169

    Sagamihara-shi, 252-0392

  • Investigational Site Number :392011

    Sakaide-shi, Kagawa-ken, 762-8550

  • Investigational Site Number :392008

    Sapporo, Hokkaido, 062-8618

  • Investigational Site Number :392034

    Sapporo, Hokkaido, 064-0804

  • Investigational Site Number :392038

    Setagaya-ku, Tokyo, 158-0097

  • Investigational Site Number :392167

    Shinagawa-ku, Tokyo, 142-8666

  • Investigational Site Number :392130

    Shinjuku-ku, 162-8655

  • Investigational Site Number :392165

    Sumida-ku, 130-8587

  • Investigational Site Number :392173

    Tachikawa-shi, Tokyo, 190-0012

  • Investigational Site Number :392146

    Tachikawa-shi, 190-0014

  • Investigational Site Number :392006

    Tomakomai-shi, Hokkaido, 053-8506

  • Investigational Site Number :392029

    Tsu, 514-0125

  • Investigational Site Number :392168

    Uozu-shi, 937-0042

  • Investigational Site Number :392132

    Urasoe-shi, 901-2121

  • Investigational Site Number :392045

    Uruma, Okinawa, 904-2293

  • Investigational Site Number :392014

    Yokohama, Kanagawa, 231-8682

Other trials in Japan

United States35 sites

  • Investigational Site Number :840070

    Allen, Texas, 75013

  • Investigational Site Number :840062

    Amarillo, Texas, 79109

  • Investigational Site Number :840064

    Bangor, Maine, 04401

  • Investigational Site Number :840951

    Bellingham, Washington, 98225

  • Investigational Site Number :840126

    Charlotte, North Carolina, 28277

  • Investigational Site Number :840052

    Chevy Chase, Maryland, 20815

  • Investigational Site Number :840124

    Cypress, Texas, 77429

  • Investigational Site Number :840023

    Dallas, Texas, 75231

  • Investigational Site Number :840403

    Denver, Colorado, 80206

  • Investigational Site Number :840130

    Denver, Colorado, 80246

  • Investigational Site Number :840035

    Draper, Utah, 84020

  • Investigational Site Number :840059

    Fairfax, Virginia, 22030

  • Investigational Site Number :840032

    Fort Mitchell, Kentucky, 41017

  • Investigational Site Number :840922

    Fort Worth, Texas, 76109

  • Investigational Site Number :840027

    Fort Worth, Texas, 76244

  • Investigational Site Number :840073

    Gaithersburg, Maryland, 20878

  • Investigational Site Number :840099

    Gilbert, Arizona, 85234

  • Investigational Site Number :840907

    High Point, North Carolina, 27262

  • Investigational Site Number :840132

    Little Rock, Arkansas, 72209

  • Investigational Site Number :840018

    Minneapolis, Minnesota, 55402

  • Investigational Site Number :840077

    Murray, Utah, 84107

  • Investigational Site Number :840115

    Ocoee, Florida, 34761

  • Investigational Site Number :840004

    Papillion, Nebraska, 27103

  • Investigational Site Number :840067

    Philadelphia, Pennsylvania, 19140

  • Investigational Site Number :840091

    Pittsburgh, Pennsylvania, 15241

  • Investigational Site Number :840008

    San Antonio, Texas, 78229

  • Investigational Site Number :840121

    San Jose, California, 95117

  • Investigational Site Number :840055

    Sarasota, Florida, 34239

  • Investigational Site Number :840087

    Scottsdale, Arizona, 85248

  • Investigational Site Number :840057

    South Burlington, Vermont, 05403

  • Investigational Site Number :840102

    St Louis, Missouri, 63141

  • Investigational Site Number :840942

    Toledo, Ohio, 43617

  • Investigational Site Number :840402

    Tucson, Arizona, 85721

  • Investigational Site Number :840079

    Twin Falls, Idaho, 83301

  • Investigational Site Number :840068

    West Long Branch, New Jersey, 07764

Other trials in United States

Argentina12 sites

  • Investigational Site Number :032096

    Bahía Blanca, Buenos Aires, B8000JRB

  • Investigational Site Number :032004

    Buenos Aires, 2317

  • Investigational Site Number :032091

    Capital Federal, Buenos Aires, C1426ABP

  • Investigational Site Number :032003

    Ciudad Autonoma Bs As, C1121ABE

  • Investigational Site Number :032097

    Ciudad Autonoma Buenos Aires, C1414AIF

  • Investigational Site Number :032010

    Ciudad Autonoma Buenos Aires, C1414CGA

  • Investigational Site Number :032001

    Ciudad Autonoma Buenos Aires, C1425BEN

  • Investigational Site Number :032002

    La Plata, Buenos Aires, B1900BNN

  • Investigational Site Number :032006

    Rosario, Santa Fe Province, S2000BRH

  • Investigational Site Number :032005

    Rosario, Santa Fe Province, S2000JKR

  • Investigational Site Number :032009

    San Miguel de Tucumán, 4000

  • Investigational Site Number :032012

    San Miguel de Tucumán, T4000CHE

Other trials in Argentina

Canada11 sites

  • Investigational Site Number :124016

    Hamilton, Ontario, L8N 4A6

  • Investigational Site Number :124010

    Montréal, Quebec, H4J 1C5

  • Investigational Site Number :124001

    Montreal, Quebec, H2X 1P1

  • Investigational Site Number :124012

    Montreal, Quebec, H3G 1A4

  • Investigational Site Number :124013

    Ottawa, Ontario, K1G 6C6

  • Investigational Site Number :124014

    Québec, Quebec, G1V 4W2

  • Investigational Site Number :124018

    Québec, G1V 4G5

  • Investigational Site Number :124002

    Toronto, Ontario, M5T 3A9

  • Investigational Site Number :124007

    Trois-Rivières, Quebec, G8T 7A1

  • Investigational Site Number :124006

    Vancouver, British Columbia, V5Z 1M9

  • Investigational Site Number :124017

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

France7 sites

  • Investigational Site Number :250009

    Brest, 29609

  • Investigational Site Number :250010

    Lille, 59037

  • Investigational Site Number :250006

    Lyon, 69317

  • Investigational Site Number :250001

    Marseille, 13015

  • Investigational Site Number :250002

    Montpellier, 34295

  • Investigational Site Number :250005

    Nantes, 44093

  • Investigational Site Number :250008

    Strasbourg, 67091

Other trials in France

South Africa7 sites

  • Investigational Site Number :710011

    Cape Town, 7505

  • Investigational Site Number :710001

    Cape Town, 7531

  • Investigational Site Number :710091

    Cape Town, 7700

  • Investigational Site Number :710092

    Cape Town, 7700

  • Investigational Site Number :710006

    Durban, 4071

  • Investigational Site Number :710007

    Pretoria, 0087

  • Investigational Site Number :710009

    Winnie Mandela, 9400

Other trials in South Africa

Germany5 sites

  • Investigational Site Number :276006

    Berlin, 10787

  • Investigational Site Number :276010

    Frankfurt am Main, 60596

  • Investigational Site Number :276011

    Großhansdorf, 22927

  • Investigational Site Number :276009

    Koblenz, 56068

  • Investigational Site Number :276005

    Rüdersdorf, 15562

Other trials in Germany

Israel3 sites

  • Investigational Site Number :376001

    Kfar Saba, 4428164

  • Investigational Site Number :376005

    Petah Tikva, 4941492

  • Investigational Site Number :376002

    Rehovot, 76100

Other trials in Israel

Belgium1 site

  • Investigational Site Number :056003

    Ghent, 9000

Other trials in Belgium

Netherlands1 site

  • Investigational Site Number :528001

    Arnhem, 6815 AD

Other trials in Netherlands

About this study

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

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).

Read the 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.

Conditions
Asthma
Being tested
Dupilumab SAR231893 (REGN668)
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893 (REGN668)Drug

    Pharmaceutical form: prefilled syringes

    Route of administration: subcutaneous

Study groups in NCT03620747
Study groupRoleWhat they receive
DupilumabExperimentalParticipants 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.
Receives: Drug: Dupilumab SAR231893 (REGN668)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

  2. 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.

    Measured: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

Secondary outcomes (2)

  1. 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.

    Measured: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

  2. 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.

    Measured: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start30 Aug 2018
  3. Primary completion18 Feb 2022
  4. Study completion18 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620747
Sponsor's protocol ID
LPS15023
Other IDs
2017-002134-23, U1111-1196-5369, 2017
Status last verified
Feb 2023
First submitted
26 Jul 2018
Last updated
16 Mar 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Maspero JF, Peters AT, Chapman KR, Domingo C, Stewart J, Hardin M, Maroni J, Tawo K, Khokhar FA, Mortensen E, Laws E, Radwan A, Jacob-Nara JA, Deniz Y, Rowe PJ. Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study. J Allergy Clin Immunol Pract. 2024 Apr;12(4):991-997.e6. doi: 10.1016/j.jaip.2023.12.043. Epub 2023 Dec 30.

    PubMed 38163585

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab SAR231893 (REGN668) in people with Asthma, run by Sanofi at 132 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in Japan, United States, Argentina, Canada, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03620747, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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