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

NCT03620747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2023-03-16

Study results available
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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).

Conditions

Interventions

DRUG

Dupilumab SAR231893 (REGN668)

Pharmaceutical form: prefilled syringes Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2022-02-18
Completion
2022-02-18
FDA Drug
Yes

Countries

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

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03620747 on ClinicalTrials.gov