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Monoclonal Antibodies
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline of parent study, weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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
Eligible Conditions
- Asthma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline of parent study, weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline of parent study, weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary study objectives
Annualized Event Rate Per Participant-Years for Severe Exacerbation
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48
+23 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT0403336712%
Accidental Overdose
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Headache
2%
Dermatitis Atopic
1%
Fall
1%
Multiple Fractures
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Dupilumab/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: dupilumab treatmentExperimental Treatment1 Intervention
For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1\* Dose every 2 weeks added to current controller medications.
For participants coming from other studies: dupilumab 1 \* Dose SC every 2 weeks added to current controller medications.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,216 Previous Clinical Trials
4,045,350 Total Patients Enrolled
51 Trials studying Asthma
27,398 Patients Enrolled for Asthma
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
383,542 Total Patients Enrolled
29 Trials studying Asthma
9,428 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
877 Previous Clinical Trials
2,020,534 Total Patients Enrolled
19 Trials studying Asthma
6,943 Patients Enrolled for Asthma