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Monoclonal Antibodies

Dupilumab for Atopic Dermatitis

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

Study Summary

This trial will study how well dupilumab works to improve quality of life for people with 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Psychological General Well-Being Scale (PGWB)

Secondary outcome measures

Dermatology Life Quality Index (DLQI)

Itch Numerical Rating Scale

PSQI

+2 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Placebo/Dupilumab

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Dupilumab/Dupilumab

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

~12230

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor

616 Previous Clinical Trials

379,811 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,521 Total Patients Enrolled

Tina Bhutani, MDPrincipal InvestigatorUniversity of California, San Francisco

4 Previous Clinical Trials

89 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to participate in this experiment?

"At this time, no new participants are being admitted to this particular medical trial. The initial posting date for the study was November 1st 2018 and it has since been amended on October 5th 2022. However, there are numerous other studies recruiting patients with dermatitis (235 trials) or who could benefit from Dupilumab treatment (49 trials)."

Answered by AI

To what ailments has Dupilumab been found to be a remedy?

"Dupilumab is an effective remedy for eosinophilic dermatitis, atopic dermatitis, and corticosteroid-resistant cases."

Answered by AI

Is this medical experiment pioneering a new treatment approach?

"As of now, 49 open trials for Dupilumab are spread across 436 cities and 43 nations. Sanofi's trial kicked off the research in 2015 with a Phase 3 drug approval process that involved 880 individuals - since then 54 studies have concluded successfully."

Answered by AI

Has Dupilumab been granted regulatory authorization by the FDA?

"Dupilumab is considered safe after undergoing Phase 4 trials, thus its safety score was evaluated as a 3."

Answered by AI

What is the participant size of this clinical experiment?

"This trial is no longer recruiting new participants. Originally posted in November 2018 and last updated on October 5th 2022, other studies with open enrollment are available; 235 trials for dermatitis and 49 trials involving the drug Dupilumab currently require applicants."

Answered by AI

Has Dupilumab been evaluated in prior research?

"Currently, Dupilumab is being studied in 49 different clinical trials with 13 at the Phase 3 stage. The bulk of those studies are located in Palo Alto, yet there are an expansive 2,602 sites hosting research on this medication."

Answered by AI