Dupixent and Narrowband UVB for Atopic Dermatitis

Sponsor

Psoriasis Treatment Center of Central New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05285839

Collaborator

Regeneron Pharmaceuticals (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Dupixent	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dupixent and Narrowband UVB Dupixent and Narrowband UVB	Drug: Dupixent dupilumab 300mg

Arm

Intervention/Treatment

Experimental: Dupixent and Narrowband UVB

Dupixent and Narrowband UVB

Drug: Dupixent

dupilumab 300mg

Outcome Measures

Primary Outcome Measures

Investigators Global Assessment Score of score of 0 or 1 [12 weeks]
Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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,

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eczema Treatment Center of New Jersey	East Windsor	New Jersey	United States	08520

Sponsors and Collaborators

Psoriasis Treatment Center of Central New Jersey
Regeneron Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Psoriasis Treatment Center of Central New Jersey

ClinicalTrials.gov Identifier:

NCT05285839

Other Study ID Numbers:

ETC01

First Posted:

Mar 18, 2022

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Eczema

Study Results

No Results Posted as of Mar 18, 2022