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

NCT03620747 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: LPS150232017-002134-23U1111-1196-5369
• Study Type: interventional
• Target: 393
• Locations: 10 countries
• Sites: 132

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 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

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

Study Arms (1)

Dupilumab

EXPERIMENTAL

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)

Interventions

Dupilumab SAR231893 (REGN668) DRUG

Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

Dupilumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (132)

Investigational Site Number :840099

Gilbert, Arizona, 85234, United States

Location

Investigational Site Number :840087

Scottsdale, Arizona, 85248, United States

Location

Investigational Site Number :840402

Tucson, Arizona, 85721, United States

Location

Investigational Site Number :840132

Little Rock, Arkansas, 72209, United States

Location

Investigational Site Number :840121

San Jose, California, 95117, United States

Location

Investigational Site Number :840403

Denver, Colorado, 80206, United States

Location

Investigational Site Number :840130

Denver, Colorado, 80246, United States

Location

Investigational Site Number :840115

Ocoee, Florida, 34761, United States

Location

Investigational Site Number :840055

Sarasota, Florida, 34239, United States

Location

Investigational Site Number :840079

Twin Falls, Idaho, 83301, United States

Location

Investigational Site Number :840032

Fort Mitchell, Kentucky, 41017, United States

Location

Investigational Site Number :840064

Bangor, Maine, 04401, United States

Location

Investigational Site Number :840052

Chevy Chase, Maryland, 20815, United States

Location

Investigational Site Number :840073

Gaithersburg, Maryland, 20878, United States

Location

Investigational Site Number :840018

Minneapolis, Minnesota, 55402, United States

Location

Investigational Site Number :840102

St Louis, Missouri, 63141, United States

Location

Investigational Site Number :840004

Papillion, Nebraska, 27103, United States

Location

Investigational Site Number :840068

West Long Branch, New Jersey, 07764, United States

Location

Investigational Site Number :840126

Charlotte, North Carolina, 28277, United States

Location

Investigational Site Number :840907

High Point, North Carolina, 27262, United States

Location

Investigational Site Number :840942

Toledo, Ohio, 43617, United States

Location

Investigational Site Number :840067

Philadelphia, Pennsylvania, 19140, United States

Location

Investigational Site Number :840091

Pittsburgh, Pennsylvania, 15241, United States

Location

Investigational Site Number :840070

Allen, Texas, 75013, United States

Location

Investigational Site Number :840062

Amarillo, Texas, 79109, United States

Location

Investigational Site Number :840124

Cypress, Texas, 77429, United States

Location

Investigational Site Number :840023

Dallas, Texas, 75231, United States

Location

Investigational Site Number :840922

Fort Worth, Texas, 76109, United States

Location

Investigational Site Number :840027

Fort Worth, Texas, 76244, United States

Location

Investigational Site Number :840008

San Antonio, Texas, 78229, United States

Location

Investigational Site Number :840035

Draper, Utah, 84020, United States

Location

Investigational Site Number :840077

Murray, Utah, 84107, United States

Location

Investigational Site Number :840057

South Burlington, Vermont, 05403, United States

Location

Investigational Site Number :840059

Fairfax, Virginia, 22030, United States

Location

Investigational Site Number :840951

Bellingham, Washington, 98225, United States

Location

Investigational Site Number :032096

Bahía Blanca, Buenos Aires, B8000JRB, Argentina

Location

Investigational Site Number :032091

Capital Federal, Buenos Aires, C1426ABP, Argentina

Location

Investigational Site Number :032002

La Plata, Buenos Aires, B1900BNN, Argentina

Location

Investigational Site Number :032006

Rosario, Santa Fe Province, S2000BRH, Argentina

Location

Investigational Site Number :032005

Rosario, Santa Fe Province, S2000JKR, Argentina

Location

Investigational Site Number :032004

Buenos Aires, 2317, Argentina

Location

Investigational Site Number :032003

Ciudad Autonoma Bs As, C1121ABE, Argentina

Location

Investigational Site Number :032097

Ciudad Autonoma Buenos Aires, C1414AIF, Argentina

Location

Investigational Site Number :032010

Ciudad Autonoma Buenos Aires, C1414CGA, Argentina

Location

Investigational Site Number :032001

Ciudad Autonoma Buenos Aires, C1425BEN, Argentina

Location

Investigational Site Number :032012

San Miguel de Tucumán, T4000CHE, Argentina

Location

Investigational Site Number :032009

San Miguel de Tucumán, 4000, Argentina

Location

Investigational Site Number :056003

Ghent, 9000, Belgium

Location

Investigational Site Number :124006

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Investigational Site Number :124017

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Investigational Site Number :124016

Hamilton, Ontario, L8N 4A6, Canada

Location

Investigational Site Number :124013

Ottawa, Ontario, K1G 6C6, Canada

Location

Investigational Site Number :124002

Toronto, Ontario, M5T 3A9, Canada

Location

Investigational Site Number :124010

Montréal, Quebec, H4J 1C5, Canada

Location

Investigational Site Number :124001

Montreal, Quebec, H2X 1P1, Canada

Location

Investigational Site Number :124012

Montreal, Quebec, H3G 1A4, Canada

Location

Investigational Site Number :124014

Québec, Quebec, G1V 4W2, Canada

Location

Investigational Site Number :124007

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Investigational Site Number :124018

Québec, G1V 4G5, Canada

Location

Investigational Site Number :250009

Brest, 29609, France

Location

Investigational Site Number :250010

Lille, 59037, France

Location

Investigational Site Number :250006

Lyon, 69317, France

Location

Investigational Site Number :250001

Marseille, 13015, France

Location

Investigational Site Number :250002

Montpellier, 34295, France

Location

Investigational Site Number :250005

Nantes, 44093, France

Location

Investigational Site Number :250008

Strasbourg, 67091, France

Location

Investigational Site Number :276006

Berlin, 10787, Germany

Location

Investigational Site Number :276010

Frankfurt am Main, 60596, Germany

Location

Investigational Site Number :276011

Großhansdorf, 22927, Germany

Location

Investigational Site Number :276009

Koblenz, 56068, Germany

Location

Investigational Site Number :276005

Rüdersdorf, 15562, Germany

Location

Investigational Site Number :376001

Kfar Saba, 4428164, Israel

Location

Investigational Site Number :376005

Petah Tikva, 4941492, Israel

Location

Investigational Site Number :376002

Rehovot, 76100, Israel

Location

Investigational Site Number :392106

Mizunami-shi, Gifu, 509-6134, Japan

Location

Investigational Site Number :392043

Ota-shi, Gunma, 373-0807, Japan

Location

Investigational Site Number :392021

Fukuyama-shi, Hiroshima, 720-0001, Japan

Location

Investigational Site Number :392108

Hiroshima, Hiroshima, 734-8530, Japan

Location

Investigational Site Number :392164

Muroran-shi, Hokkaido, 0143-0076, Japan

Location

Investigational Site Number :392008

Sapporo, Hokkaido, 062-8618, Japan

Location

Investigational Site Number :392034

Sapporo, Hokkaido, 064-0804, Japan

Location

Investigational Site Number :392006

Tomakomai-shi, Hokkaido, 053-8506, Japan

Location

Investigational Site Number :392162

Kobe, Hyōgo, 650-0017, Japan

Location

Investigational Site Number :392020

Naka-gun, Ibaraki, 319-1113, Japan

Location

Investigational Site Number :392011

Sakaide-shi, Kagawa-ken, 762-8550, Japan

Location

Investigational Site Number :392014

Yokohama, Kanagawa, 231-8682, Japan

Location

Investigational Site Number :392153

Kyoto, Kyoto, 615-8087, Japan

Location

Investigational Site Number :392170

Osaki-shi, Miyagi, 989-6183, Japan

Location

Investigational Site Number :392045

Uruma, Okinawa, 904-2293, Japan

Location

Investigational Site Number :392119

Kishiwada-shi, Osaka, 596-8501, Japan

Location

Investigational Site Number :392005

Naruto-shi, Tokushima, 772-0017, Japan

Location

Investigational Site Number :392002

Chuo-ku, Tokyo, 103-0028, Japan

Location

Investigational Site Number :392112

Chuo-ku, Tokyo, 104-0031, Japan

Location

Investigational Site Number :392133

Machida-shi, Tokyo, 194-0023, Japan

Location

Investigational Site Number :392177

Ome-shi, Tokyo, 198-0042, Japan

Location

Investigational Site Number :392038

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Investigational Site Number :392167

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Investigational Site Number :392173

Tachikawa-shi, Tokyo, 190-0012, Japan

Location

Investigational Site Number :392185

Akashi-shi, 674-0063, Japan

Location

Investigational Site Number :392007

Chūōku, 103-0027, Japan

Location

Investigational Site Number :392012

Edogawa-ku, 134-0083, Japan

Location

Investigational Site Number :392030

Habikino-shi, 583-8588, Japan

Location

Investigational Site Number :392004

Himeji-shi, 672-8064, Japan

Location

Investigational Site Number :392158

Hiroshima, 732-0052, Japan

Location

Investigational Site Number :392013

Iizuka-shi, 820-8505, Japan

Location

Investigational Site Number :392042

Isesaki-shi, 372-0831, Japan

Location

Investigational Site Number :392142

Kasuga-shi, 816-0813, Japan

Location

Investigational Site Number :392040

Kodaira-shi, 187-0024, Japan

Location

Investigational Site Number :392044

Kokubunji-shi, 185-0014, Japan

Location

Investigational Site Number :392010

Kurashiki-shi, 712-8064, Japan

Location

Investigational Site Number :392036

Kyoto, 612-0026, Japan

Location

Investigational Site Number :392144

Minatoku, 105-0003, Japan

Location

Investigational Site Number :392122

Minatoku, 108-8606, Japan

Location

Investigational Site Number :392163

Nagoya, 454-8509, Japan

Location

Investigational Site Number :392155

Osakasayama-shi, 589-0022, Japan

Location

Investigational Site Number :392152

Osakasayama-shi, 589-8511, Japan

Location

Investigational Site Number :392127

Ōta-ku, 145-0071, Japan

Location

Investigational Site Number :392169

Sagamihara-shi, 252-0392, Japan

Location

Investigational Site Number :392130

Shinjuku-ku, 162-8655, Japan

Location

Investigational Site Number :392165

Sumida-ku, 130-8587, Japan

Location

Investigational Site Number :392146

Tachikawa-shi, 190-0014, Japan

Location

Investigational Site Number :392029

Tsu, 514-0125, Japan

Location

Investigational Site Number :392168

Uozu-shi, 937-0042, Japan

Location

Investigational Site Number :392132

Urasoe-shi, 901-2121, Japan

Location

Investigational Site Number :528001

Arnhem, 6815 AD, Netherlands

Location

Investigational Site Number :710011

Cape Town, 7505, South Africa

Location

Investigational Site Number :710001

Cape Town, 7531, South Africa

Location

Investigational Site Number :710091

Cape Town, 7700, South Africa

Location

Investigational Site Number :710092

Cape Town, 7700, South Africa

Location

Investigational Site Number :710006

Durban, 4071, South Africa

Location

Investigational Site Number :710007

Pretoria, 0087, South Africa

Location

Investigational Site Number :710009

Winnie Mandela, 9400, South Africa

Location

Related Publications (1)

• 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.

  PMID: 38163585 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 8, 2018
• Study Start: August 30, 2018
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: March 16, 2023
• Results First Posted: March 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (11); NL (1); BE (1); IL (3); US (35); JP (50); ZA (7); AR (12); DE (5); FR (7)