Trials / Completed
CompletedNCT03620747
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 393 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab SAR231893 (REGN668) | Pharmaceutical form: prefilled syringes Route of administration: subcutaneous |
Timeline
- Start date
- 2018-08-30
- Primary completion
- 2022-02-18
- Completion
- 2022-02-18
- First posted
- 2018-08-08
- Last updated
- 2023-03-16
- Results posted
- 2023-03-16
Locations
132 sites across 10 countries: United States, Argentina, Belgium, Canada, France, Germany, Israel, Japan, Netherlands, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03620747. Inclusion in this directory is not an endorsement.