Phase 3
Completed N=393
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
Asthma
Source: ClinicalTrials.gov NCT03620747 ↗
Enrolled (actual)
393
Serious AEs
5.6%
Results posted
Mar 2023
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 54.5 percentage of participants
◆ Published Evidence
Emerging
17citations · ~9 / year
Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study.
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).
Linked Publications
-
Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
54.5 | — |
| PRIMARY Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years) |
171.4 | — |
| SECONDARY Adverse Events of Special Interest (AESIs) Event Rate (Event Per100 Participant-years) |
6.0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Study Discontinuation |
5.6; 6.1; 1.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03620747) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.