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Monoclonal Antibodies

dupilumab treatment for Asthma

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

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline of parent study, weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study for reporting.

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 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

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
2,189 Previous Clinical Trials
4,031,002 Total Patients Enrolled
49 Trials studying Asthma
25,361 Patients Enrolled for Asthma
Regeneron PharmaceuticalsIndustry Sponsor
655 Previous Clinical Trials
382,985 Total Patients Enrolled
29 Trials studying Asthma
9,428 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
871 Previous Clinical Trials
2,018,569 Total Patients Enrolled
19 Trials studying Asthma
6,981 Patients Enrolled for Asthma
~206 spots leftby Oct 2025
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