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Janus Kinase (JAK) Inhibitor
Upadacitinib for Eczema (Measure Up 1 Trial)
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
Must not have
Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
Select...
I do not have active skin diseases or infections that need systemic treatment.
Select...
I do not need medications that are not allowed in the study.
Select...
I cannot or do not want to stop my current skin treatment before the study.
Select...
I have previously taken a JAK inhibitor medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
RASH
12%
ACUTE RESPIRATORY FAILURE
12%
WEIGHT INCREASED
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
LIGAMENT RUPTURE
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PNEUMONIA BACTERIAL
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
SEBORRHOEIC KERATOSIS
6%
ACUTE KIDNEY INJURY
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
HERPES ZOSTER
6%
OSTEOARTHRITIS
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
PATELLA FRACTURE
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~11250
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,023 Previous Clinical Trials
519,377 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
159,863 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used a moisturizer twice a day for at least a week.Your eczema is very severe, with a score of 16 or higher on a special scale.Your skin condition is rated as moderate or worse by the study doctor at the screening and baseline visits.I have had chronic eczema for over 3 years.You experience severe itching most days of the week.My skin condition didn't improve with creams or pills in the last 6 months.I do not have active skin diseases or infections that need systemic treatment.I do not need medications that are not allowed in the study.I need or recently needed treatment that affects my whole body for my condition.I cannot or do not want to stop my current skin treatment before the study.I am between 12 and 18 years old and weigh at least 40 kg.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.Your eczema is severe, with an Eczema Area and Severity Index (EASI) score of 16 or higher.I have previously taken a JAK inhibitor medication.At least 10% of my skin is affected by my condition.You have had an average daily itchiness score of 4 or higher in the past week.At least 10% of my skin is affected by my condition.Your skin condition has a score of 3 or higher as determined by the study doctor.I have moderate to severe atopic dermatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Upadacitinib 30 mg QD
- Group 2: Upadacitinib 15 mg QD
- Group 3: Placebo / Upadacitinib
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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