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Monoclonal Antibodies
The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
Phase 4
Waitlist Available
Led By Tina Bhutani, MD
Research Sponsored by University of California, San Francisco
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 16 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests how dupilumab affects the quality of life in patients with moderate to severe atopic dermatitis. Dupilumab helps reduce skin inflammation and irritation, aiming to improve patients' overall well-being. Dupilumab is the first biological agent approved for treatment of moderate-to-severe atopic dermatitis.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Psychological General Well-Being Scale (PGWB)
Secondary study objectives
Dermatology Life Quality Index (DLQI)
Itch Numerical Rating Scale
PSQI
+2 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
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
30 subjects will receive dupilumab for a treatment period of 52 weeks. All patients quality of life measures will be assessed with Psychological General Well-Being scale (PGWB), Work Productivity and Activity Impairment scale (WPAI), and Dermatology Life Quality Index (DLQI). Symptom and satisfaction will be assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), Itch Numerical Rating Scale, Pain Numerical Rating Scale, and Pittsburgh Sleep Quality Assessment (PSQI).
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?
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,809 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,590 Previous Clinical Trials
14,901,369 Total Patients Enrolled
Tina Bhutani, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
89 Total Patients Enrolled