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-LTS12551Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002134-23-BE

Enrollment

750

Registered

2018-06-28

Start date

2018-08-10

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Dupilumab Product Code: SAR231893 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Dupilumab Current Sponsor code: SAR231893 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551. -Signed written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 560 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: - Patients who experienced any systemic hypersensitivity reactions to the IMP in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient - Clinically significant comorbidity/lung disease other than asthma - Patients with active autoimmune disease or patients who, as per Investigator's medical judgment, are 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 nonmetastatic squamous or basal cell carcinoma of the skin

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).;Secondary Objective: Not applicable;Primary end point(s): 1. Treatment-emergent adverse events (TEAE) : Percentage of patients reporting any TEAE. 2. TEAE : Event rates per 100 patient-years.;Timepoint(s) of evaluation of this end point: 1. Up to 3 years. 2. Up to 3 years.	—

Measure

Time frame

Main Objective: To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).;Secondary Objective: Not applicable;Primary end point(s): 1. Treatment-emergent adverse events (TEAE) : Percentage of patients reporting any TEAE. 2. TEAE : Event rates per 100 patient-years.;Timepoint(s) of evaluation of this end point: 1. Up to 3 years. 2. Up to 3 years.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

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

Contacts

Public ContactBrigitte De Witte

Sanofi Belgium

CTA.Belgium@sanofi.com+32 (0)2 710 54 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026