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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620747
• Other study ID #: LPS15023
• Secondary ID: 2017-002134-23U1
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2018
• Est. completion date: February 18, 2022

Study information

• Verified date: February 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Argentina	Investigational Site Number :032096	Bahia Blanca	Buenos Aires
Argentina	Investigational Site Number :032004	Buenos Aires
Argentina	Investigational Site Number :032091	Capital Federal	Buenos Aires
Argentina	Investigational Site Number :032003	Ciudad Autonoma Bs As
Argentina	Investigational Site Number :032001	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number :032010	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number :032097	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number :032002	La Plata	Buenos Aires
Argentina	Investigational Site Number :032005	Rosario	Santa Fe
Argentina	Investigational Site Number :032006	Rosario	Santa Fe
Argentina	Investigational Site Number :032009	San Miguel De Tucumán
Argentina	Investigational Site Number :032012	San Miguel de Tucuman
Belgium	Investigational Site Number :056003	Gent
Canada	Investigational Site Number :124016	Hamilton	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 :124013	Ottawa	Ontario
Canada	Investigational Site Number :124014	Québec	Quebec
Canada	Investigational Site Number :124018	Quebec
Canada	Investigational Site Number :124002	Toronto	Ontario
Canada	Investigational Site Number :124007	Trois-Rivieres	Quebec
Canada	Investigational Site Number :124006	Vancouver	British Columbia
Canada	Investigational Site Number :124017	Vancouver	British Columbia
France	Investigational Site Number :250009	Brest cedex 2
France	Investigational Site Number :250010	Lille Cedex
France	Investigational Site Number :250006	Lyon cedex 04
France	Investigational Site Number :250001	Marseille
France	Investigational Site Number :250002	Montpellier cedex 5
France	Investigational Site Number :250005	Nantes cedex
France	Investigational Site Number :250008	Strasbourg
Germany	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	Ruedersdorf
Israel	Investigational Site Number :376001	Kfar- Sava
Israel	Investigational Site Number :376005	Petach-Tikva
Israel	Investigational Site Number :376002	Rehovot
Japan	Investigational Site Number :392185	Akashi-shi
Japan	Investigational Site Number :392002	Chuo-ku	Tokyo
Japan	Investigational Site Number :392007	Chuo-Ku
Japan	Investigational Site Number :392112	Chuo-ku	Tokyo
Japan	Investigational Site Number :392012	Edogawa-ku
Japan	Investigational Site Number :392021	Fukuyama-shi	Hiroshima
Japan	Investigational Site Number :392030	Habikino-shi
Japan	Investigational Site Number :392004	Himeji-shi
Japan	Investigational Site Number :392108	Hiroshima-shi	Hiroshima
Japan	Investigational Site Number :392158	Hiroshima-shi
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 :392119	Kishiwada-shi	Osaka
Japan	Investigational Site Number :392162	Kobe-shi	Hyogo
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-shi
Japan	Investigational Site Number :392153	Kyoto-shi	Kyoto
Japan	Investigational Site Number :392133	Machida-shi	Tokyo
Japan	Investigational Site Number :392122	Minato-ku
Japan	Investigational Site Number :392144	Minato-ku
Japan	Investigational Site Number :392106	Mizunami-shi	Gifu
Japan	Investigational Site Number :392164	Muroran-shi	Hokkaido
Japan	Investigational Site Number :392163	Nagoya-shi
Japan	Investigational Site Number :392020	Naka-gun	Ibaraki
Japan	Investigational Site Number :392005	Naruto-shi	Tokushima
Japan	Investigational Site Number :392177	Ome-shi	Tokyo
Japan	Investigational Site Number :392152	Osakasayama-shi
Japan	Investigational Site Number :392155	Osakasayama-shi
Japan	Investigational Site Number :392170	Osaki-shi	Miyagi
Japan	Investigational Site Number :392127	Ota-ku
Japan	Investigational Site Number :392043	Ota-shi	Gunma
Japan	Investigational Site Number :392169	Sagamihara-shi
Japan	Investigational Site Number :392011	Sakaide-shi	Kagawa
Japan	Investigational Site Number :392008	Sapporo-shi	Hokkaido
Japan	Investigational Site Number :392034	Sapporo-shi	Hokkaido
Japan	Investigational Site Number :392038	Setagaya-ku	Tokyo
Japan	Investigational Site Number :392167	Shinagawa-ku	Tokyo
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 :392173	Tachikawa-shi	Tokyo
Japan	Investigational Site Number :392006	Tomakomai-shi	Hokkaido
Japan	Investigational Site Number :392029	Tsu-shi
Japan	Investigational Site Number :392168	Uozu-shi
Japan	Investigational Site Number :392132	Urasoe-shi
Japan	Investigational Site Number :392045	Uruma-shi	Okinawa
Japan	Investigational Site Number :392014	Yokohama-shi	Kanagawa
Netherlands	Investigational Site Number :528001	Arnhem
South Africa	Investigational Site Number :710009	Brandfort
South Africa	Investigational Site Number :710001	Cape Town
South Africa	Investigational Site Number :710011	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
United States	Investigational Site Number :840070	Allen	Texas
United States	Investigational Site Number :840062	Amarillo	Texas
United States	Investigational Site Number :840064	Bangor	Maine
United States	Investigational Site Number :840951	Bellingham	Washington
United States	Investigational Site Number :840126	Charlotte	North Carolina
United States	Investigational Site Number :840052	Chevy Chase	Maryland
United States	Investigational Site Number :840124	Cypress	Texas
United States	Investigational Site Number :840023	Dallas	Texas
United States	Investigational Site Number :840130	Denver	Colorado
United States	Investigational Site Number :840403	Denver	Colorado
United States	Investigational Site Number :840035	Draper	Utah
United States	Investigational Site Number :840059	Fairfax	Virginia
United States	Investigational Site Number :840032	Fort Mitchell	Kentucky
United States	Investigational Site Number :840027	Fort Worth	Texas
United States	Investigational Site Number :840922	Fort Worth	Texas
United States	Investigational Site Number :840073	Gaithersburg	Maryland
United States	Investigational Site Number :840099	Gilbert	Arizona
United States	Investigational Site Number :840907	High Point	North Carolina
United States	Investigational Site Number :840132	Little Rock	Arkansas
United States	Investigational Site Number :840018	Minneapolis	Minnesota
United States	Investigational Site Number :840077	Murray	Utah
United States	Investigational Site Number :840115	Ocoee	Florida
United States	Investigational Site Number :840004	Papillion	Nebraska
United States	Investigational Site Number :840067	Philadelphia	Pennsylvania
United States	Investigational Site Number :840091	Pittsburgh	Pennsylvania
United States	Investigational Site Number :840102	Saint Louis	Missouri
United States	Investigational Site Number :840008	San Antonio	Texas
United States	Investigational Site Number :840121	San Jose	California
United States	Investigational Site Number :840055	Sarasota	Florida
United States	Investigational Site Number :840087	Scottsdale	Arizona
United States	Investigational Site Number :840057	South Burlington	Vermont
United States	Investigational Site Number :840942	Toledo	Ohio
United States	Investigational Site Number :840402	Tucson	Arizona
United States	Investigational Site Number :840079	Twin Falls	Idaho
United States	Investigational Site Number :840068	West Long Branch	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)