Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

NCT06684522 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STU00221561
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the efficacy of upadacitinib in eyelid dermatitis that has not resolved with topical therapies and patch testing.

Conditions

Eyelid Dermatitis

Outcome Measures

Primary Outcomes (1)

• Reduction in Investigator Global Assessment (IGA)

  Reduction in baseline IGA score at week 12 compared to week 0

  12 weeks

Study Arms (1)

Upadacitinib Treatment

EXPERIMENTAL

Participants on upadacitinib 15mg daily

Drug: Upadacitinib 15 MG

Interventions

Upadacitinib 15 MG DRUG

Upadacitinib 15mg daily

Also known as: RINVOQ

Upadacitinib Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 18-70 years old with eyelid dermatitis for at least two months
• Failure of at least one topical prescription cream for the eyelid dermatitis (steroid, pimecrolimus, tacrolimus, crisaborole, or ruxolitinib)
• Women of reproductive potential must agree to using effective contraception during treatment and for 4 weeks following the final dose of Upadacitinib.
• Willing and able participants that provide informed consent
• Willing and able participants that comply with study activities

You may not qualify if:

• Self-reported history of allergic response to upadacitinib
• Subject with self-reported history of heart disease, stroke, or neurological conditions
• Currently taking topical medications for eyelid dermatitis within one week of starting study drug
• Women who are pregnant, nursing, or who may become pregnant during the study
• Non-English-speaking subjects
• Patients with an active serious infection
• Patients with active TB or latent TB, patients should be tested for TB prior to upadacitinib treatment.
• Patients with active HBV/HCV or abnormal lab ranges, Lab Data: Hb\<8g/dL, ALC\<500 cells/mm3 and ANC \<1000 cells/mm3
• Patients with a history of malignancy within the last 5 years other than successfully treated NMSC.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

upadacitinib

Study Officials

• Walter Liszewski

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dermatology CTU

CONTACT

312-503-5944; NUderm-research@northwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-10

Locations

US (1)