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Monoclonal Antibodies

Dupilumab 200 mg q2w 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2, 4, 8, 12, 24, 36, and 52
Awards & highlights

Summary

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2, 4, 8, 12, 24, 36, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 2, 4, 8, 12, 24, 36, and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population
Secondary study objectives
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L
+34 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dupilumab 300 mg q2wExperimental Treatment4 Interventions
2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Group II: Dupilumab 200 mg q2wExperimental Treatment4 Interventions
2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Group III: Placebo (for Dupilumab 200 mg) q2wPlacebo Group4 Interventions
2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Group IV: Placebo (for Dupilumab 300 mg) q2wPlacebo Group4 Interventions
2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inhaled corticosteroid (ICS) therapy
2015
Completed Phase 3
~2120
Salbutamol
FDA approved
Levosalbutamol
FDA approved
Dupilumab
FDA approved

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Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
655 Previous Clinical Trials
383,365 Total Patients Enrolled
29 Trials studying Asthma
9,808 Patients Enrolled for Asthma
SanofiLead Sponsor
2,189 Previous Clinical Trials
4,031,382 Total Patients Enrolled
49 Trials studying Asthma
25,741 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
871 Previous Clinical Trials
2,018,949 Total Patients Enrolled
19 Trials studying Asthma
7,361 Patients Enrolled for Asthma
~183 spots leftby Oct 2025
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