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dupilumab for Atopic Dermatitis

UCSF, San Francisco, CA
Atopic Dermatitis+1 More Conditionsdupilumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial studies if a drug called dupilumab can help reduce symptoms of atopic dermatitis (eczema) in people aged 12 and older with moderate-to-severe symptoms.

Eligible Conditions
  • Atopic Dermatitis
  • Eczema

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Study Objectives

1 Primary · 27 Secondary · Reporting Duration: Baseline to Weeks 4, 12 and 24

Week 24
Trough concentration of functional dupilumab in serum
At Week 24
Proportion of participants with eczema area and severity index (EASI)-75
Week 4
Change in total and allergen-specific immunoglobulin (E) IgEs
Percent change in total and allergen-specific IgEs
Week 24
Absolute change from baseline in EASI
Absolute change from baseline in weekly average of daily PP NRS
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
Eczema
Change from baseline in health-related QOL as measured by Children's Dermatology Life Quality Index (CDLQI; age <16)
Change from baseline in health-related quality of life (QOL) as measured by Dermatology Life Quality Index (DLQI; age ≥16)
Change from baseline in percent body surface area (BSA)
Change from baseline in weekly average Sleep Quality NRS
Percent change from baseline in EASI
Percent change from baseline in total SCORing atopic dermatitis (AD) (SCORAD) component scores
Percent change from baseline in weekly average of daily PP NRS
Proportion of participants with EASI-50
Proportion of participants with EASI-75
Proportion of participants with EASI-90
Proportion of participants with Investigator's Global Assessment (IGA) = 0 to 1
Proportion of participants with SCORAD-50
Proportion of participants with improvement (reduction) of weekly average of daily PP NRS ≥4
Proportion of participants with improvement (reduction) of weekly average of daily Peak Pruritus (PP) Numerical Rating Scale (NRS) ≥3 from baseline
Week 24
Change from baseline in Skin Pain NRS (SP NRS)
Week 24
Eczema
Proportion of participants who rate their eczema symptoms in the patient global impression of change (PGIC) as "Much better"
Proportion of participants with PGID response as No symptoms or Mild symptoms
Proportion of patient global impression of disease (PGID) response as No symptoms
Week 24
Incidence of non-herpetic skin infection treatment-emergent adverse events (TEAEs)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Pazopanib
2
Ruxolitinib Cream
2
ASLAN004

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

dupilumab
1 of 1

Experimental Treatment

120 Total Participants · 1 Treatment Group

Primary Treatment: dupilumab · No Placebo Group · Phase 4

dupilumabExperimental Group · 2 Interventions: dupilumab, Topical emollient (moisturizer) · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2021
Completed Phase 3
~190

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to weeks 4, 12 and 24

Who is running the clinical trial?

SanofiIndustry Sponsor
2,077 Previous Clinical Trials
3,005,987 Total Patients Enrolled
Regeneron PharmaceuticalsLead Sponsor
562 Previous Clinical Trials
355,943 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
235 Previous Clinical Trials
243,481 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have moderate to severe atopic dermatitis that cannot be managed with topical medications.
References

Frequently Asked Questions

How efficacious is dupilumab in promoting health and wellbeing?

"Thanks to it's Phase 4 status, dupilumab has earned a score of 3 indicating established safety." - Anonymous Online Contributor

Unverified Answer

Is there still enrollment capacity for this investigation?

"Affirmative. Clinicaltrials.gov states that the trial, initially published on November 1st 2023, is currently recruiting participants. A total of 120 patients are needed from 30 separate medical facilities." - Anonymous Online Contributor

Unverified Answer

How many different locations are hosting this research endeavor?

"Presently, 30 clinics are running this trial. Of these sites, Montgomery, Fremont and La Jolla have the most opportunities for participation. It is suggested that patients enroll in a clinic nearest to them so as to offset travel demands." - Anonymous Online Contributor

Unverified Answer

To what extent is participant enrollment in this investigation?

"This study necessitates the recruitment of 120 patients that match the trial's requirements. Sanofi, as the main sponsor, will be running this clinical test from multiple research centres including The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham in Montgomery, California and C2 Research Center, LLC in Fremont, Florida." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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