Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab S... | NCT03620747

ID	Type	Description	Link
2017-002134-23	EudraCT Number
U1111-1196-5369	Other Identifier	UTN

Status Module

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Name	Type	Description	Arm Group Labels	Other Names
Dupilumab SAR231893 (REGN668)	Drug	Pharmaceutical form: prefilled syringes Route of administration: subcutaneous	Dupilumab

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number :840099		Gilbert	Arizona	85234	United States
Investigational Site Number :840087

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38163585	Derived	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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, 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 27, 2018	Feb 15, 2023

Arm/Group Information

ID	Title	Description
BG000	Dupilumab	Participants received SC dose of dupilumab 300 mg q2w from Week 0 up to Week 132. Participants who discontinued treatment for >= 6 weeks after study LTS12551, received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose ICS as maintained in study LTS12551 in combination with controllers (and/or OCS for those participants from the original parent study EFC13691). Salbutamol/albuterol hydrofluoroalkane pressurized MDI or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00054.5(47.40 to 62.26)

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.

Analysis was performed on safety population.

Posted

Number

95% Confidence Interval

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)

ID	Title	Description
OG000	Dupilumab	Participants received SC dose of dupilumab 300 mg q2w from Week 0 up to Week 132. Participants who discontinued treatment for >= 6 weeks after study LTS12551, received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose ICS as maintained in study LTS12551 in combination with controllers (and/or OCS for those participants from the original parent study EFC13691). Salbutamol/albuterol hydrofluoroalkane pressurized MDI or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.

Units	Counts

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.

Analysis was performed on safety population.

Posted

Number

95% Confidence Interval

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)

ID	Title	Description
OG000	Dupilumab	Participants received SC dose of dupilumab 300 mg q2w from Week 0 up to Week 132. Participants who discontinued treatment for >= 6 weeks after study LTS12551, received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose ICS as maintained in study LTS12551 in combination with controllers (and/or OCS for those participants from the original parent study EFC13691). Salbutamol/albuterol hydrofluoroalkane pressurized MDI or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.

Units	Counts

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.

Analysis was performed on safety population.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Dupilumab	Participants received SC dose of dupilumab 300 mg q2w from Week 0 up to Week 132. Participants who discontinued treatment for >= 6 weeks after study LTS12551, received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose ICS as maintained in study LTS12551 in combination with controllers (and/or OCS for those participants from the original parent study EFC13691). Salbutamol/albuterol hydrofluoroalkane pressurized MDI or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dupilumab	Participants received SC dose of dupilumab 300 mg q2w from Week 0 up to Week 132. Participants who discontinued treatment for >= 6 weeks after study LTS12551, received a 600 mg loading dose of dupilumab on Week 0. Participants were also on background dose of medium or high dose ICS as maintained in study LTS12551 in combination with controllers (and/or OCS for those participants from the original parent study EFC13691). Salbutamol/albuterol hydrofluoroalkane pressurized MDI or levosalbutamol/levalbuterol hydrofluoroalkane pressurized MDI were given as reliever medication as needed during the study.	5	393	22	393	93	393

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Epilepsy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Pudendal canal syndrome	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Cataract	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0005 events4 affected393 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected393 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected393 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected393 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG00077 events52 affected393 at risk
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00024 events22 affected393 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00036 events33 affected393 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases