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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Dupilumab SAR231893 (REGN668)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03620747

2017-002134-23 (EudraCT Number)

LPS15023

U1111-1196-5369 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 393 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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393 participants in 1 patient group

Dupilumab

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab SAR231893 (REGN668)