Upadacitinib for Blepharitis

Overseen By Dermatology CTU

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Topical medications

Disqualifiers: Heart disease, Stroke, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called upadacitinib, a JAK inhibitor, for individuals with eyelid dermatitis unresponsive to creams or ointments. The main goal is to determine if upadacitinib can reduce the symptoms of this condition. Suitable candidates have experienced eyelid dermatitis for at least two months and have tried at least one prescription cream without success. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical medications for eyelid dermatitis at least one week before starting the study drug.

Is there any evidence suggesting that upadacitinib is likely to be safe for humans?

Research has shown that upadacitinib is generally safe, but some risks exist. Studies found its safety profile similar to other treatments and placebos. However, upadacitinib may increase the risk of infections that could lead to hospitalization or death. There is also a risk of serious heart-related problems.

Upadacitinib is already approved for other conditions, indicating it is considered safe for those uses. It is crucial to weigh the benefits and risks and consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for blepharitis, which often include antibiotics, anti-inflammatory drugs, or eyelid scrubs, upadacitinib offers a novel approach by targeting the Janus kinase (JAK) pathways. This mechanism helps reduce inflammation at the cellular level, potentially offering more direct and effective relief. Researchers are excited about upadacitinib because it is an oral medication, which could be more convenient for patients compared to topical treatments or frequent eye care routines. By focusing on the root cause of inflammation, upadacitinib might provide faster and more sustained results for those struggling with blepharitis.

What evidence suggests that upadacitinib might be an effective treatment for blepharitis?

Research has shown that upadacitinib may help treat various inflammatory conditions. For example, studies found it significantly improved skin symptoms in conditions like vitiligo, with patients experiencing up to a 75% reduction in visible symptoms. In other inflammatory conditions, upadacitinib helped many patients achieve clinical remission. This trial will evaluate upadacitinib's potential to reduce inflammation and improve symptoms in eyelid dermatitis, especially when other creams or ointments have failed. Although specific data for blepharitis is limited, its ability to reduce inflammation makes it a promising option. ^{5 6 7 8 9}

Who Is on the Research Team?

Walter Liszewski

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals with persistent eyelid dermatitis, which hasn't improved after using topical treatments and undergoing patch testing. Specific eligibility details are not provided.

Inclusion Criteria

Willing and able participants that comply with study activities

I have tried at least one prescription cream for my eyelid dermatitis without success.

I agree to use birth control during and for 4 weeks after my treatment ends.

Exclusion Criteria

Self-reported history of allergic response to upadacitinib

I am not pregnant, nursing, or planning to become pregnant during the study.

I am using topical medications for eyelid dermatitis and started within the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive upadacitinib 15mg daily for eyelid dermatitis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Upadacitinib

Trial Overview The study is evaluating the effectiveness of a medication called Upadacitinib at a dose of 15 MG in treating refractory eyelid dermatitis.

How Is the Trial Designed?

Group I: Upadacitinib Treatment Experimental Treatment 1 Intervention

Participants on upadacitinib 15mg daily

Upadacitinib is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis
• Ulcerative colitis
• Crohn's disease

Approved in United States as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis
• Ulcerative colitis
• Crohn's disease

Approved in Canada as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A total of 4,494 adverse event reports associated with upadacitinib were identified from over 3.8 million reports in the FDA database, indicating a significant number of potential safety concerns.

The study revealed unexpected adverse events such as arthralgia, musculoskeletal stiffness, diverticulitis, and cataracts, with most adverse events occurring within the first four months of treatment, highlighting the need for careful clinical monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Marketing Safety Concerns with Upadacitinib: A Disproportionality Analysis of the FDA Adverse Event Reporting system. Wu, XP., Lu, XK., Wang, ZT., et al.[2023]

In a study involving 661 patients with rheumatoid arthritis (RA) who did not respond adequately to conventional DMARDs, upadacitinib (15 mg and 30 mg) significantly improved patient-reported outcomes such as pain, physical function, and overall disease activity after 12 weeks compared to placebo.

Patients taking upadacitinib reported clinically meaningful improvements in various measures, with the number needed to treat (NNT) for these benefits ranging from 4 to 8, indicating that a small number of patients need to be treated for one to experience significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Strand, V., Pope, J., Tundia, N., et al.[2021]

Upadacitinib, a selective JAK1 inhibitor, demonstrated an oral bioavailability of approximately 80% for its extended-release formulation compared to the immediate-release version, based on a pharmacokinetic analysis of 11,658 plasma concentrations from 1,145 subjects across multiple studies.

The study found that while certain factors like sex and renal function can affect drug levels in the body, these variations are not expected to lead to clinically significant changes in the drug's effectiveness or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects With Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis, or Atopic Dermatitis: Population Analyses of Phase 1 and 2 Clinical Trials. Nader, A., Stodtmann, S., Friedel, A., et al.[2021]

Upadacitinib, an oral JAK-1 inhibitor, received marketing approval in the USA in August 2019 for treating moderately to severely active rheumatoid arthritis after showing positive results in multinational phase III trials.

The approval was specifically for patients who had an inadequate response or intolerance to methotrexate, highlighting its role as an effective alternative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib: First Approval. Duggan, S., Keam, SJ.[2020]

In a phase 3 trial involving patients with psoriatic arthritis who did not respond to previous treatments, upadacitinib showed significant improvements in patient-reported outcomes (PROs) compared to placebo and was as effective as adalimumab, particularly in measures like the Health Assessment Questionnaire Disability Index (HAQ-DI) and the SF-36 Physical Component Summary score.

Patients treated with upadacitinib experienced rapid improvements in symptoms as early as week 2, with sustained benefits observed through week 56, indicating its efficacy in enhancing quality of life for those with psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. Strand, V., Mease, PJ., Soriano, ER., et al.[2022]

Upadacitinib has been evaluated for long-term safety in 6991 patients across various conditions, showing that it is generally well tolerated with similar rates of treatment-emergent adverse events (TEAEs) across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis.

While the overall safety profile is favorable, certain risks such as herpes zoster and non-melanoma skin cancer were higher in patients with rheumatoid arthritis and psoriatic arthritis compared to active comparators, indicating the need for careful monitoring in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. Burmester, GR., Cohen, SB., Winthrop, KL., et al.[2023]

Upadacitinib significantly improves rheumatoid arthritis symptoms, with a 3.71 times higher likelihood of achieving a 20% improvement in the ACR20 score compared to placebo, based on data from 3233 patients.

While upadacitinib is effective, it is associated with a higher incidence of adverse events and infections compared to placebo, particularly at the 12 mg twice daily dosage, although the 15 mg once daily dose combined with Methotrexate showed the best efficacy without significant treatment-related risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis Evaluating the Effectiveness and Safety of Upadacitinib in Treating Rheumatoid Arthritis in Patients With Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs. Panchal, V., Vyas, BH., Sivasubramanian, BP., et al.[2023]

Citations

1. news.abbvie.com news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo

AbbVie Announces Positive Topline Results from Phase 3 ... In both studies, upadacitinib achieved the co-primary endpoints of T-VASI 50 (≥50% reduction from baseline in T-VASI score) and F-VASI 75 (≥75% ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK600005/

Clinical Review - Upadacitinib (Rinvoq) - NCBI Bookshelf - NIH The results for other efficacy outcomes suggested that treatment with upadacitinib was associated with better symptom relief and improved health-related quality ...

3. pharmacytimes.com pharmacytimes.com/view/fda-approves-updated-indication-for-upadacitinib-in-patients-with-ibd

FDA Approves Updated Indication for Upadacitinib in ... During the maintenance trial, 42% and 52% of patients who received 15 mg and 30 mg of upadacitinib, respectively, achieved clinical remission at ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138271/

Long-term safety and efficacy of upadacitinib versus ... Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years. Upadacitinib demonstrates a favourable benefit–risk ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/211675Orig1s004.pdf

center for drug evaluation and research - accessdata.fda.gov The study should evaluate the treatment benefit of higher upadacitinib dosage in subjects who had inadequate response to the initial upadacitinib lower dosage.

6. rinvoqhcp.com rinvoqhcp.com/dermatology/safety

RINVOQ® (upadacitinib) Safety Data Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10838816/

Safety of Upadacitinib in Immune-Mediated Inflammatory ... Most studies suggested that upadacitinib has no statistically significant difference in the studied safety outcomes compared to active treatments or placebo.

8. news.abbvie.com news.abbvie.com/2017-09-07-AbbVies-Upadacitinib-ABT-494-Meets-Primary-Endpoint-in-Phase-2b-Study-in-Atopic-Dermatitis

AbbVie's Upadacitinib (ABT-494) Meets Primary Endpoint ... A 75 percent improvement in disease (EASI 75) was achieved by 69/52/29 percent of patients receiving the 30/15/7.5 mg doses of upadacitinib ...

9. rinvoqhcp.com rinvoqhcp.com/safety

RINVOQ® (upadacitinib) Safety Profile Patients treated with RINVOQ are at increased risk for developing infections that may lead to hospitalization or death.