NCT05285839

Brief Summary

24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

March 8, 2022

Last Update Submit

March 14, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Investigators Global Assessment Score of score of 0 or 1

    Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12

    12 weeks

Study Arms (1)

Dupixent and Narrowband UVB

EXPERIMENTAL

Dupixent and Narrowband UVB

Drug: Dupixent

Interventions

DupixentDRUG

dupilumab 300mg

Dupixent and Narrowband UVB

Eligibility Criteria

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

You may qualify if:

  • Male or female adult ≥ 18 years of age;
  • Diagnosis of moderate to severe atopic dermatitis as defined at baseline by:
  • EASI score of 16 or greater,
  • IGA score of 3 or greater
  • BSA of 10% or greater,

You may not qualify if:

  • Subjects with previous exposure to dupilumab.
  • Known or suspected hypersensitivity to dupilumab or any of its excipients.
  • History of photosensitivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eczema Treatment Center of New Jersey

East Windsor, New Jersey, 08520, 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

Central Study Contacts

Elise Nelson

CONTACT

6094434500enelson@windsordermatology.com

Study Design

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

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 18, 2022

Study Start

April 19, 2022

Primary Completion

December 1, 2024

Study Completion

December 15, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)