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

NCT ID: NCT03620747

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 393 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2022-02-18

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dupilumab SAR231893 (REGN668)

Intervention Type: DRUG

Pharmaceutical form: prefilled syringes

Route of administration: subcutaneous

Interventions

Dupilumab SAR231893 (REGN668)

Pharmaceutical form: prefilled syringes

Route of administration: subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number :840099

Gilbert, Arizona, United States

Investigational Site Number :840087

Scottsdale, Arizona, United States

Investigational Site Number :840402

Tucson, Arizona, United States

Investigational Site Number :840132

Little Rock, Arkansas, United States

Investigational Site Number :840121

San Jose, California, United States

Investigational Site Number :840403

Denver, Colorado, United States

Investigational Site Number :840130

Denver, Colorado, United States

Investigational Site Number :840115

Ocoee, Florida, United States

Investigational Site Number :840055

Sarasota, Florida, United States

Investigational Site Number :840079

Twin Falls, Idaho, United States

Investigational Site Number :840032

Fort Mitchell, Kentucky, United States

Investigational Site Number :840064

Bangor, Maine, United States

Investigational Site Number :840052

Chevy Chase, Maryland, United States

Investigational Site Number :840073

Gaithersburg, Maryland, United States

Investigational Site Number :840018

Minneapolis, Minnesota, United States

Investigational Site Number :840102

St Louis, Missouri, United States

Investigational Site Number :840004

Papillion, Nebraska, United States

Investigational Site Number :840068

West Long Branch, New Jersey, United States

Investigational Site Number :840126

Charlotte, North Carolina, United States

Investigational Site Number :840907

High Point, North Carolina, United States

Investigational Site Number :840942

Toledo, Ohio, United States

Investigational Site Number :840067

Philadelphia, Pennsylvania, United States

Investigational Site Number :840091

Pittsburgh, Pennsylvania, United States

Investigational Site Number :840070

Allen, Texas, United States

Investigational Site Number :840062

Amarillo, Texas, United States

Investigational Site Number :840124

Cypress, Texas, United States

Investigational Site Number :840023

Dallas, Texas, United States

Investigational Site Number :840922

Fort Worth, Texas, United States

Investigational Site Number :840027

Fort Worth, Texas, United States

Investigational Site Number :840008

San Antonio, Texas, United States

Investigational Site Number :840035

Draper, Utah, United States

Investigational Site Number :840077

Murray, Utah, United States

Investigational Site Number :840057

South Burlington, Vermont, United States

Investigational Site Number :840059

Fairfax, Virginia, United States

Investigational Site Number :840951

Bellingham, Washington, United States

Investigational Site Number :032096

Bahía Blanca, Buenos Aires, Argentina

Investigational Site Number :032091

Capital Federal, Buenos Aires, Argentina

Investigational Site Number :032002

La Plata, Buenos Aires, Argentina

Investigational Site Number :032006

Rosario, Santa Fe Province, Argentina

Investigational Site Number :032005

Rosario, Santa Fe Province, Argentina

Investigational Site Number :032004

Buenos Aires, , Argentina

Investigational Site Number :032003

Ciudad Autonoma Bs As, , Argentina

Investigational Site Number :032097

Ciudad Autonoma Buenos Aires, , Argentina

Investigational Site Number :032010

Ciudad Autonoma Buenos Aires, , Argentina

Investigational Site Number :032001

Ciudad Autonoma Buenos Aires, , Argentina

Investigational Site Number :032012

San Miguel de Tucumán, , Argentina

Investigational Site Number :032009

San Miguel de Tucumán, , Argentina

Investigational Site Number :056003

Ghent, , Belgium

Investigational Site Number :124006

Vancouver, British Columbia, Canada

Investigational Site Number :124017

Vancouver, British Columbia, Canada

Investigational Site Number :124016

Hamilton, Ontario, Canada

Investigational Site Number :124013

Ottawa, Ontario, Canada

Investigational Site Number :124002

Toronto, Ontario, Canada

Investigational Site Number :124010

Montréal, Quebec, Canada

Investigational Site Number :124001

Montreal, Quebec, Canada

Investigational Site Number :124012

Montreal, Quebec, Canada

Investigational Site Number :124014

Québec, Quebec, Canada

Investigational Site Number :124007

Trois-Rivières, Quebec, Canada

Investigational Site Number :124018

Québec, , Canada

Investigational Site Number :250009

Brest, , France

Investigational Site Number :250010

Lille, , France

Investigational Site Number :250006

Lyon, , France

Investigational Site Number :250001

Marseille, , France

Investigational Site Number :250002

Montpellier, , France

Investigational Site Number :250005

Nantes, , France

Investigational Site Number :250008

Strasbourg, , France

Investigational Site Number :276006

Berlin, , Germany

Investigational Site Number :276010

Frankfurt am Main, , Germany

Investigational Site Number :276011

Großhansdorf, , Germany

Investigational Site Number :276009

Koblenz, , Germany

Investigational Site Number :276005

Rüdersdorf, , Germany

Investigational Site Number :376001

Kfar Saba, , Israel

Investigational Site Number :376005

Petah Tikva, , Israel

Investigational Site Number :376002

Rehovot, , Israel

Investigational Site Number :392106

Mizunami-shi, Gifu, Japan

Investigational Site Number :392043

Ota-shi, Gunma, Japan

Investigational Site Number :392021

Fukuyama-shi, Hiroshima, Japan

Investigational Site Number :392108

Hiroshima, Hiroshima, Japan

Investigational Site Number :392164

Muroran-shi, Hokkaido, Japan

Investigational Site Number :392008

Sapporo, Hokkaido, Japan

Investigational Site Number :392034

Sapporo, Hokkaido, Japan

Investigational Site Number :392006

Tomakomai-shi, Hokkaido, Japan

Investigational Site Number :392162

Kobe, Hyōgo, Japan

Investigational Site Number :392020

Naka-gun, Ibaraki, Japan

Investigational Site Number :392011

Sakaide-shi, Kagawa-ken, Japan

Investigational Site Number :392014

Yokohama, Kanagawa, Japan

Investigational Site Number :392153

Kyoto, Kyoto, Japan

Investigational Site Number :392170

Osaki-shi, Miyagi, Japan

Investigational Site Number :392045

Uruma, Okinawa, Japan

Investigational Site Number :392119

Kishiwada-shi, Osaka, Japan

Investigational Site Number :392005

Naruto-shi, Tokushima, Japan

Investigational Site Number :392002

Chuo-ku, Tokyo, Japan

Investigational Site Number :392112

Chuo-ku, Tokyo, Japan

Investigational Site Number :392133

Machida-shi, Tokyo, Japan

Investigational Site Number :392177

Ome-shi, Tokyo, Japan

Investigational Site Number :392038

Setagaya-ku, Tokyo, Japan

Investigational Site Number :392167

Shinagawa-ku, Tokyo, Japan

Investigational Site Number :392173

Tachikawa-shi, Tokyo, Japan

Investigational Site Number :392185

Akashi-shi, , Japan

Investigational Site Number :392007

Chūōku, , Japan

Investigational Site Number :392012

Edogawa-ku, , Japan

Investigational Site Number :392030

Habikino-shi, , Japan

Investigational Site Number :392004

Himeji-shi, , Japan

Investigational Site Number :392158

Hiroshima, , Japan

Investigational Site Number :392013

Iizuka-shi, , Japan

Investigational Site Number :392042

Isesaki-shi, , Japan

Investigational Site Number :392142

Kasuga-shi, , Japan

Investigational Site Number :392040

Kodaira-shi, , Japan

Investigational Site Number :392044

Kokubunji-shi, , Japan

Investigational Site Number :392010

Kurashiki-shi, , Japan

Investigational Site Number :392036

Kyoto, , Japan

Investigational Site Number :392144

Minatoku, , Japan

Investigational Site Number :392122

Minatoku, , Japan

Investigational Site Number :392163

Nagoya, , Japan

Investigational Site Number :392155

Osakasayama-shi, , Japan

Investigational Site Number :392152

Osakasayama-shi, , Japan

Investigational Site Number :392127

Ōta-ku, , Japan

Investigational Site Number :392169

Sagamihara-shi, , Japan

Investigational Site Number :392130

Shinjuku-ku, , Japan

Investigational Site Number :392165

Sumida-ku, , Japan

Investigational Site Number :392146

Tachikawa-shi, , Japan

Investigational Site Number :392029

Tsu, , Japan

Investigational Site Number :392168

Uozu-shi, , Japan

Investigational Site Number :392132

Urasoe-shi, , Japan

Investigational Site Number :528001

Arnhem, , Netherlands

Investigational Site Number :710011

Cape Town, , South Africa

Investigational Site Number :710001

Cape Town, , South Africa

Investigational Site Number :710091

Cape Town, , South Africa

Investigational Site Number :710092

Cape Town, , South Africa

Investigational Site Number :710006

Durban, , South Africa

Investigational Site Number :710007

Pretoria, , South Africa

Investigational Site Number :710009

Winnie Mandela, , South Africa

Countries

United States; Argentina; Belgium; Canada; France; Germany; Israel; Japan; Netherlands; South Africa

References

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.

Reference Type: DERIVED

PMID: 38163585 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-002134-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1196-5369

Identifier Type: OTHER

Identifier Source: secondary_id

LPS15023

Identifier Type: -

Identifier Source: org_study_id