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Janus Kinase (JAK) Inhibitor

Upadacitinib for Atopic Dermatitis (Flex-Up Trial)

Phase 4

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to Baseline and participant meets Hanifin and Rajka criteria

Baseline weekly average of daily Worst Pruritus NRS >= 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Flex-Up Trial Summary

This trial is evaluating the dosing flexibility of upadacitinib in adult participants with moderate to severe atopic dermatitis.

Who is the study for?

Adults aged 18-64 with moderate to severe atopic dermatitis (eczema) for over 3 years, who need systemic treatment because skin creams aren't enough or suitable. They should have a certain level of itchiness and affected body area. People can't join if they've had recent serious heart issues, organ transplants, allergies to study drug ingredients, high risk of stomach perforation, absorption problems, certain cancers or infections like HIV/TB/herpes or uncontrolled COVID-19.Check my eligibility

What is being tested?

The trial tests the flexibility of dosing Upadacitinib in pill form for adults with eczema. It includes a double-blind period where participants don't know their dose for 12 weeks followed by another 12-week single-blind period with dose adjustments based on response. The goal is to see how well different doses manage eczema symptoms.See study design

What are the potential side effects?

Upadacitinib may cause side effects such as cold-like symptoms, headaches, nausea and potential increased risk of infection due to its immune system effects. Participants will be monitored through medical exams and blood tests to track any adverse reactions.

Flex-Up Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had chronic eczema for over 3 years.

Select...

I often feel severe itching.

Select...

My eczema is severe, covering more than 10% of my body.

Flex-Up Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 90

Secondary outcome measures

Percentage of Participants Achieving DLQI of 0 or 1

Percentage of Participants Achieving EASI 100

Percentage of Participants Achieving EASI 75

+7 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

Flex-Up Trial Design

6Treatment groups

Experimental Treatment

Group I: Single-Blinded Treatment Period Arm DExperimental Treatment1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group II: Single-Blinded Treatment Period Arm CExperimental Treatment1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group III: Single-Blinded Treatment Period Arm BExperimental Treatment1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group IV: Single-Blinded Treatment Period Arm AExperimental Treatment1 Intervention

Participants will be administered updadacitinib once daily (QD) for 12 weeks.

Group V: Double-Blind Treatment Period Dose BExperimental Treatment1 Intervention

Participants will be administered updadacitinib Dose B once daily (QD) for 12 weeks.

Group VI: Double-Blind Treatment Period Dose AExperimental Treatment1 Intervention

Participants will be administered updadacitinib Dose A once daily (QD) for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,583 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,417 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05507580 — Phase 4

Atopic Dermatitis Research Study Groups: Single-Blinded Treatment Period Arm C, Single-Blinded Treatment Period Arm D, Double-Blind Treatment Period Dose A, Double-Blind Treatment Period Dose B, Single-Blinded Treatment Period Arm A, Single-Blinded Treatment Period Arm B

Atopic Dermatitis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT05507580 — Phase 4

Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507580 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this trial for participants?

"At present, this trial is not enrolling any participants. Despite being initially posted on December 16th 2022 and lastly updated August 18th 2022, the research team has decided to temporarily suspend recruitment. On a brighter note, there are still 235 other clinical trials in need of patients right now."

Answered by AI

Who can apply to join this research project?

"The criterion for acceptance into this study requires a diagnosis of dermatitis and being in the age range of 18-64. The team is currently trying to recruit 600 participants."

Answered by AI

In what areas is this research accessible?

"Five locations are currently participating in this medical trial, including K. Papp Clinical Research (ID# 246698) located in Waterloo, Dermatology Research Institute Inc. (ID# 246703 based out of Calgary), and Dr. Chih-ho Hong Medical Inc.(ID# 246700 found in Markham)."

Answered by AI

Has the Food and Drug Administration sanctioned Upadacitinib?

"There is ample evidence that Upadacitinib has been proven safe and thus, it was given a score of 3."

Answered by AI

What is the proposed goal of this medical experiment?

"This 24-week trial's primary outcome will be measured by the Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75. Secondary outcomes include a measure for the Percentage of Participants Achieving EASI 90, which is calculated using an index that evaluates both area and severity of eczematous skin lesions; another secondary outcome measures those achieving EASI 100 according to the same metric; and lastly, they are also assessing participants who have attained EASI 90 combined with Worst Pruritus NRS equal to or below 1 - this single item scale assesses peak pruritus"

Answered by AI

Does this study's criteria include elderly individuals aged 80 and up?

"The trial requires that all participants are aged between 18 and 64 years old. There is a separate cohort of 101 patients younger than 18, as well as an additional 165 individuals older than 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

2023. "A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05507580.

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