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Janus Kinase (JAK) Inhibitor

Upadacitinib for Eczema (Measure Up 1 Trial)

Q: What are some of the most common reasons that doctors prescribe Upadacitinib?

Upadacitinib is often used to treat patients that may need systemic therapy. Additionally, this medication can be taken to alleviate other issues like <a href="https://www.withpower.com/clinical-trials/rheumatoid-arthritis">rheumatoid arthritis</a>, methotrexate, and an inadequate response to conventional therapy.

Q: Does Upadacitinib have any serious short-term or long-term side effects?

There is some evidence to support the efficacy of Upadacitinib, as it has progressed to a Phase 3 clinical trial. Furthermore, the safety of Upadacitinib has been corroborated by multiple rounds of testing, so it receives a score of 3.

Q: What do we know about Upadacitinib from other research?

Upadacitinib is being trialled in 21 studies at the moment, 14 of which are in Phase 3. The locations for these trials are quite widespread, with 3924 different centres running Upadacitinib trials in Singapore and Central Singapore.

Q: If a patient is over 45 years old, can they still participate in this research?

To be eligible for this particular clinical trial, applicants must fall between the ages of 12 and 75. Out of the total of 316 clinical trials, 116 are for patients who are under 18 and 202 are for patients above the age of 65.

Q: Is this the first clinical trial to test this particular treatment?

There have been 21 clinical trials for Upadacitinib since 2015, with the most recent one completed in 2020. These trials have taken place across 953 cities in 54 countries. The first study, sponsored by AbbVie, enrolled 1629 patients and completed Phase 3 drug approval in 2015.

Q: Is this trial being run in many different places across Canada?

This clinical trial is running atSkin Care Research, LLC /ID# 200811 in Boca Raton, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>, Dr. Irina Turchin PC Inc. /ID# 200322 in Fredericton, New Brunswick, and Kirk Barber Research, CA /ID# 200324 in Kew Gardens, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> as well as 74 other locations.

Q: What are researchers looking to understand through this clinical trial?

The goal of this clinical trial is to evaluate the efficacy of the medication in treating <a href="https://www.withpower.com/clinical-trials/atopic-dermatitis">atopic dermatitis</a>. The trial will last for 16 weeks, and the primary outcome measure will be the percentage of participants achieving a validated investigator global assessment (vIGA) of 0 or 1 with at least two grades of reduction from baseline. Secondary objectives include the percentage of participants achieving a reduction of ≥ 4 points from baseline in worst pruritus NRS at week 1, the percentage of participants achieving a 100% reduction from baseline in EASI score at week 16, and the percentage of adolescents achieving an EASI 75 response at week 16

Q: What is the scope of this research in terms of participants?

The clinical trial you are inquiring about is no longer recruiting patients. It was first posted on 8/13/2018, with the last edit on 2/2/2022. However, there are 259 other trials for <a href="https://www.withpower.com/clinical-trials/eczema">eczema</a> and 21 trials for Upadacitinib that are still looking for participants.

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years of age

Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Measure Up 1 Trial Summary

This trial will test if a new drug, upadacitinib, is effective and safe for treating moderate to severe atopic dermatitis in adolescents and adults.

Who is the study for?

This trial is for adolescents and adults with moderate to severe atopic dermatitis (eczema) who weigh at least 40 kg, have a history of inadequate response to certain topical treatments, and are candidates for systemic therapy. Participants should not be pregnant or breastfeeding, must discontinue other eczema treatments before the study, and cannot have used JAK inhibitors previously.Check my eligibility

What is being tested?

The trial is testing Upadacitinib's effectiveness in treating moderate to severe eczema compared to a placebo. It aims to see if this drug can improve symptoms in those who haven't responded well enough to topical therapies.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with drugs like Upadacitinib may include infections, headaches, nausea, and potential liver issues. The exact side effects will be monitored throughout the trial.

Measure Up 1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 12 and 18 years old and weigh at least 40 kg.

Select...

My skin condition didn't improve with creams or pills in the last 6 months.

Select...

At least 10% of my skin is affected by my condition.

Select...

At least 10% of my skin is affected by my condition.

Select...

I have moderate to severe atopic dermatitis.

Measure Up 1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16

Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

Secondary outcome measures

Adolescents: Percent Change From Baseline in EASI Score at Week 16

Adolescents: Percent Change From Baseline in SCORAD Score at Week 16

Adolescents: Percent Change From Baseline in Worst Pruritus NRS at Week 16

+41 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

Measure Up 1 Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Upadacitinib 30 mg QDExperimental Treatment1 Intervention

Participants will receive upadacitinib 30 mg orally once a day for up to 260 weeks.

Group II: Upadacitinib 15 mg QDExperimental Treatment1 Intervention

Participants will receive upadacitinib 15 mg orally once a day for up to 260 weeks.

Group III: Placebo / UpadacitinibPlacebo Group2 Interventions

Participants will receive placebo orally once a day (QD) for 16 weeks in the double-blind treatment period. At Week 16 participants will be re-randomized to receive either upadacitinib 15 mg or upadacitinib 30 mg QD up to Week 260.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,193 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,027 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03569293 — Phase 3

Atopic Dermatitis Research Study Groups: Upadacitinib 30 mg QD, Upadacitinib 15 mg QD, Placebo / Upadacitinib

Atopic Dermatitis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03569293 — Phase 3

Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03569293 — Phase 3

Frequently Asked Questions

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

What are some of the most common reasons that doctors prescribe Upadacitinib?

"Upadacitinib is often used to treat patients that may need systemic therapy. Additionally, this medication can be taken to alleviate other issues like rheumatoid arthritis, methotrexate, and an inadequate response to conventional therapy."

Answered by AI

Does Upadacitinib have any serious short-term or long-term side effects?

"There is some evidence to support the efficacy of Upadacitinib, as it has progressed to a Phase 3 clinical trial. Furthermore, the safety of Upadacitinib has been corroborated by multiple rounds of testing, so it receives a score of 3."

Answered by AI

What do we know about Upadacitinib from other research?

"Upadacitinib is being trialled in 21 studies at the moment, 14 of which are in Phase 3. The locations for these trials are quite widespread, with 3924 different centres running Upadacitinib trials in Singapore and Central Singapore."

Answered by AI

If a patient is over 45 years old, can they still participate in this research?

"To be eligible for this particular clinical trial, applicants must fall between the ages of 12 and 75. Out of the total of 316 clinical trials, 116 are for patients who are under 18 and 202 are for patients above the age of 65."

Answered by AI

Is this the first clinical trial to test this particular treatment?

"There have been 21 clinical trials for Upadacitinib since 2015, with the most recent one completed in 2020. These trials have taken place across 953 cities in 54 countries. The first study, sponsored by AbbVie, enrolled 1629 patients and completed Phase 3 drug approval in 2015."

Answered by AI

Is this trial being run in many different places across Canada?

"This clinical trial is running atSkin Care Research, LLC /ID# 200811 in Boca Raton, Florida, Dr. Irina Turchin PC Inc. /ID# 200322 in Fredericton, New Brunswick, and Kirk Barber Research, CA /ID# 200324 in Kew Gardens, New york as well as 74 other locations."

Answered by AI

What are researchers looking to understand through this clinical trial?

"The goal of this clinical trial is to evaluate the efficacy of the medication in treating atopic dermatitis. The trial will last for 16 weeks, and the primary outcome measure will be the percentage of participants achieving a validated investigator global assessment (vIGA) of 0 or 1 with at least two grades of reduction from baseline. Secondary objectives include the percentage of participants achieving a reduction of ≥ 4 points from baseline in worst pruritus NRS at week 1, the percentage of participants achieving a 100% reduction from baseline in EASI score at week 16, and the percentage of adolescents achieving an EASI 75 response at week 16"

Answered by AI

What is the scope of this research in terms of participants?

"The clinical trial you are inquiring about is no longer recruiting patients. It was first posted on 8/13/2018, with the last edit on 2/2/2022. However, there are 259 other trials for eczema and 21 trials for Upadacitinib that are still looking for participants."

Answered by AI