Upadacitinib as a Novel Treatment for Refractory Eyelid D... | NCT06684522

Studies
Upadacitinib as a Novel Treatment for Refractory Eyelid Dermatitis

NCT06684522

Sponsor

Northwestern University

Status

Recruiting

Last Update Posted

May 26, 2026Actual

Enrollment

10Estimated

Phase

Early Phase 1

Conditions

Eyelid Dermatitis

Interventions

Upadacitinib 15 MG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2025Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Nov 10, 2024

First Submission Date that Met QC Criteria

Nov 10, 2024

First Posted Date

Nov 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upadacitinib Treatment	Experimental	Participants on upadacitinib 15mg daily	Drug: Upadacitinib 15 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upadacitinib 15 MG	Drug	Upadacitinib 15mg daily	Upadacitinib Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in Investigator Global Assessment (IGA)	Reduction in baseline IGA score at week 12 compared to week 0	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dermatology CTU	Contact	312-503-5944		NUderm-research@northwestern.edu

Overall Officials

Name	Affiliation	Role
Walter Liszewski	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Department of Dermatology	Recruiting	Chicago	Illinois	60611	United States