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Janus Kinase (JAK) Inhibitor

Upadacitinib for Pediatric Eczema

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.
Meets Hanifin and Rajka criteria for AD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial looks at the safety, how the body processes, and side effects of a medication given to children with severe eczema. The study also looks at how palatable the medication is to children.

Who is the study for?
This trial is for children with severe atopic dermatitis (eczema) who've had symptoms for at least 6 months. They must weigh over 10 kg and be aged 3 or older, have tried treatments like topical steroids without success, and meet specific criteria for AD severity. Kids who've used JAK inhibitors or certain other drugs recently can't participate.Check my eligibility
What is being tested?
The study tests multiple doses of Upadacitinib in kids with severe eczema to see how safe it is, how the body processes it, and if the oral solution tastes okay. It's about finding out if this medication could help manage their skin condition effectively.See study design
What are the potential side effects?
While not specified here, common side effects of medications like Upadacitinib may include infections, headaches, nausea, and potential changes in blood test results. The exact side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 10kg and am at least 3 years old.
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I have been diagnosed with atopic dermatitis according to specific criteria.
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I have been diagnosed with atopic dermatitis for over 6 months.
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I've had a bad reaction or no improvement from specific skin treatments in the last year.
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I have been diagnosed with atopic dermatitis according to Hanifin and Rajka's criteria.
Select...
I have severe eczema as diagnosed by a doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve within a dosing interval (AUCtau)
Maximum Plasma Concentration (Cmax)
Number of Participants With Treatment Emergent Adverse Events (TEAE)
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment1 Intervention
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
Group II: Part 1; Cohort 4Experimental Treatment1 Intervention
Participants, 2 to <6 years of age, will receive high dose of upadacitinib.
Group III: Part 1; Cohort 3Experimental Treatment1 Intervention
Participants, 2 to <6 years of age, will receive low dose of upadacitinib.
Group IV: Part 1; Cohort 2Experimental Treatment1 Intervention
Participants, 6 to <12 years of age, will receive high dose of upadacitinib.
Group V: Part 1; Cohort 1Experimental Treatment1 Intervention
Participants, 6 to <12 years of age, will receive low dose of upadacitinib.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
945 Previous Clinical Trials
496,371 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
141,124 Total Patients Enrolled

Media Library

Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03646604 — Phase 1
Atopic Dermatitis Research Study Groups: Part 1; Cohort 4, Part 2, Part 1; Cohort 1, Part 1; Cohort 2, Part 1; Cohort 3
Atopic Dermatitis Clinical Trial 2023: Upadacitinib (ABT-494) Highlights & Side Effects. Trial Name: NCT03646604 — Phase 1
Upadacitinib (ABT-494) (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03646604 — Phase 1

Frequently Asked Questions

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

Can you elucidate on the other scientific investigations related to Upadacitinib (ABT-494)?

"First investigated in 2015, Upadacitinib (ABT-494) has since been studied extensively. A total of 21 trials have already been completed, with an additional 21 currently enrolling participants at various medical centres - the largest concentration being in Salt Lake City, Utah."

Answered by AI

How many locations are involved in conducting this trial?

"Presently, 15 different sites are accepting participants for this trial. Salt Lake City, Coral Gables and Arlington are among the many locations that one can register at to participate in this study. To reduce any travelling needs, it is recommended to choose a site closest to your area of residence should you decide to take part."

Answered by AI

What is the maximum number of participants accepted to this trial?

"At this moment in time, recruitment for the clinical trial is closed. The study was initially posted on January 31st 2019 and last updated August 1st 2022. If you are seeking alternative trials, 235 different studies involving eczema in infants require participants as do 21 studies which utilize Upadacitinib (ABT-494)."

Answered by AI

What primary illnesses is Upadacitinib (ABT-494) utilized to address?

"Patients suffering from systemic conditions such as rheumatoid arthritis that cannot be treated using methotrexate may benefit from Upadacitinib (ABT-494) therapy."

Answered by AI

Is this the earliest iteration of research into this topic?

"Currently, there are 21 ongoing studies concerning the drug Upadacitinib (ABT-494) taking place in 54 different countries and 953 cities. The first clinical trial of this medication was launched by AbbVie back in 2015 and involved 1629 patients who completed Phase 3 trials successfully. Since then, an additional 21 research projects have been accomplished."

Answered by AI

Has Upadacitinib (ABT-494) received the necessary regulatory clearance from the FDA?

"As this is a Phase 1 trial, meaning there exists little data verifying efficacy and safety for Upadacitinib (ABT-494), our team assessed it to be at the lower end of risk, with a score of 1."

Answered by AI

Is the age restriction for this trial limited to those over 25 years of age?

"The age requirements for this research are between 2 years and 12 years. In total, there is a range of 108 clinical trials available to minors and 184 studies targeting the elderly population."

Answered by AI

Are there any eligibility requirements to join this clinical trial?

"This medical trial currently needs 32 participants aged between 2 and 12 years old who suffer from infantile eczema. Other criteria for enrolment include a minimum body weight of 10 kilograms at the baseline visit, confirmation that their symptoms meet Hanifin & Rajka's definition of Atopic dermatitis (AD), active severe AD as indicated by Eczema Area Severity Index (EASI) scores, Investigator Global Assessment (IGA) readings, and Body Surface Area (BSA). Lastly, it is necessary to have documented evidence that topical corticosteroids or calcineurin inhibitors are either ineffective or medically inad"

Answered by AI

Is enrollment for this medical experiment still open?

"According to clinicaltrials.gov, this trial has closed recruitment since August 1st 2022 and is no longer actively seeking participants. Initially posted on January 31st 2019, 256 other studies are available for potential enrolment at present."

Answered by AI

Who else is applying?

What site did they apply to?
Children's Hospital Los Angeles /ID# 206042
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Aug 2024