Phase 3
Completed N=2,282
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Source: ClinicalTrials.gov NCT02134028 ↗Enrolled (actual)
2,282
Serious AEs
10.3%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 88; 369; 414; 789 Participants
◆ Published Evidence
Established
26citations · ~7 / year
Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines.
Summary
Primary Objective:
To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).
Secondary Objectives:
To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.
To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:
* Systemic exposure
* Anti-drug antibodies
* Biomarkers
Linked Publications (5)
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Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines.
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Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study.
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Impact of dupilumab across seasons in patients with type 2, uncontrolled, moderate-to-severe asthma.
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Long-term Safety and Efficacy of Dupilumab in Patients With Uncontrolled, Moderate-to-Severe Asthma Recruited From Korean Centers: A Subgroup Analysis of the Phase 3 LIBERTY ASTHMA TRAVERSE Trial.
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Dupilumab efficacy in patients with type 2 asthma and early Feno level reductions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
88; 369; 414; 789; 74; 70 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period |
4; 12; 19; 40; 0; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period |
2; 7; 12; 29; 0; 3 | — |
| SECONDARY Number of Severe Exacerbation Events |
62; 242; 234; 437; 35; 41 | — |
| SECONDARY Annualized Event Rate Per Participant-Years for Severe Exacerbation |
0.314; 0.330; 0.351; 0.331; 0.302; 0.391 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96 |
0.24; 0.28; 0.34; 0.36; 0.31; 0.33 | — |
| SECONDARY Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96 |
9.21; 10.42; 11.74; 12.16; 10.45; 12.41 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96 |
0.22; 0.25; 0.30; 0.35; 0.29; 0.38 | — |
| SECONDARY Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96 |
0.27; 0.31; 0.39; 0.39; 0.34; 0.29 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48 |
-1.37; -1.48; -1.61; -1.68; -1.09; -1.15 | — |
| SECONDARY Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48 |
82.7; 80.8; 84.0; 86.5; 67.7; 70.1 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48 |
1.07; 1.28; 1.38; 1.38; 0.99; 0.97 | — |
| SECONDARY Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48 |
67.6; 73.6; 77.6; 77.2; 64.2; 61.4 | — |
| SECONDARY Serum Concentrations of Dupilumab Over Time Till Week 96 |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants With Antidrug Antibodies (ADA) Response |
10.8; 12.1; 9.5; 4.5; 7.4; 8.9 | — |
| SECONDARY Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96 |
0.007; -0.041; -0.096; -0.099; 0.098; 0.016 | — |
| SECONDARY Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 |
13.26; 22.95; 13.63; 21.69 | — |
| SECONDARY Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544 |
4.65; 11.97; 1.16; 10.05 | — |
| SECONDARY Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 |
-0.49; -0.68; -0.52; -0.76 | — |
| SECONDARY Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544 |
-0.47; -0.72; -0.49; -0.79 | — |
| SECONDARY Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544 |
-0.00; 0.68; -0.14; -0.82 | — |
| SECONDARY Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544 |
-0.27; -0.43; -0.29; -0.49 | — |
| SECONDARY Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691 |
55.32; 80.23; 71.37; 88.16 | — |
| SECONDARY Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691 |
64.9; 86.0; 82.1; 94.7 | — |
| SECONDARY Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691 |
31.2; 59.6; 42.9; 78.9 | — |
| SECONDARY Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544 |
0.13; 0.14; 0.12; 0.13 | — |
| SECONDARY Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544 |
10.10; 12.88; 9.90; 13.95 | — |
Eligibility Criteria
Inclusion criteria
- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.
Exclusion criteria
- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (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 participant.
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 (NCT02134028) 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.