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Monoclonal Antibodies
Dupilumab/Dupilumab for Atopic Dermatitis
Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 14 days after last imp administration (i.e., up to week 12)
Awards & highlights
Study Summary
This trial will evaluate the effect of the drug dupilumab on sleep quality in people with moderate to severe atopic dermatitis. Secondary objectives include assessing the effect of the drug on other aspects of atopic dermatitis and sleep, as well as safety and tolerability.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 14 days after last imp administration (i.e., up to week 24)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 14 days after last imp administration (i.e., up to week 24)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
Secondary outcome measures
DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Eczema
DB Period: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a (SF8a) Total T-Score at Week 12
+11 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
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
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dupilumab/DupilumabExperimental Treatment1 Intervention
Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
Group II: Placebo/DupilumabPlacebo Group2 Interventions
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
626 Previous Clinical Trials
381,920 Total Patients Enrolled
SanofiLead Sponsor
2,168 Previous Clinical Trials
3,516,443 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
2,020,154 Total Patients Enrolled
Frequently Asked Questions
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