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

Completed · Phase 3

Conditions studied: Asthma

In brief

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).

Key facts

Study ID

NCT03620747

Run by

Sanofi

People needed

393

Starts

2018-08-30

Expected to finish

2022-02-18

Last updated by the study team

2023-03-16

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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 :840099 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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