NCT05858619

Brief Summary

This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

May 4, 2023

Last Update Submit

June 25, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks

    Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity.

    baseline and 8-12 weeks

Study Arms (1)

dupilumab treatment

EXPERIMENTAL

Treatment with IL4RA inhibitor

Drug: Dupilumab

Interventions

DupilumabDRUG

dupilumab 600 mg injection initially and then 300 mg every other week

dupilumab treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7

You may not qualify if:

  • Known pregnancy
  • Known immunodeficiencies
  • Known parasitic infection -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jeffrey Cheng, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Raymond Cho, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Cheng, MD, PhD

CONTACT

415 575 0524rashes@ucsf.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)