What side effects are associated with this type of intervention?

Common treatments for Atopic Dermatitis, particularly JAK inhibitors like Upadacitinib, have several known side effects. These include acne, nasopharyngitis, upper respiratory infections, headache, and elevated creatine phosphokinase levels. Additionally, there can be a worsening of atopic dermatitis symptoms. Other systemic therapies for AD, such as dupilumab, may cause conjunctivitis and injection site reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Upadacitinib is a Janus kinase (JAK) inhibitor being studied for the treatment of moderate to severe atopic dermatitis. Other JAK inhibitors that have been approved by the FDA for the treatment of atopic dermatitis include baricitinib. Additionally, dupilumab, an IL-4 receptor alpha antagonist, has been approved for moderate to severe AD and is often used as a systemic treatment. These treatments represent significant advancements in the management of AD, offering new options for patients who require systemic therapy.

What other types of research exist?

Promising novel alternatives to Upadacitinib for Atopic Dermatitis patients include other JAK inhibitors such as Tofacitinib and Ruxolitinib, which have shown efficacy in treating severe alopecia areata and psoriasis, conditions with similar inflammatory pathways. Additionally, emerging treatments like Omalizumab, which has shown effectiveness in severe pediatric AD, and other biologics targeting specific immune pathways (e.g., IL-23/IL-17 inhibitors) may also be considered.

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Janus Kinase (JAK) Inhibitor

Upadacitinib for Eczema

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

Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA) affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating scale (NRS) score ≥ 4.

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

Must not have

Prior exposure to any Janus kinase (JAK) inhibitor

Unable or unwilling to discontinue current AD treatments prior to the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Pivotal Trial

Summary

This trial is testing upadacitinib, an oral medication, to see if it can help people with severe eczema. The medication works by calming down the overactive immune system to reduce skin inflammation and itching. Upadacitinib is approved in many countries for the treatment of atopic dermatitis in individuals whose disease is not adequately controlled with other treatments or when those treatments are not suitable.

Who is the study for?

This trial is for adolescents and adults with moderate to severe atopic dermatitis (eczema) who haven't responded well to topical treatments or need systemic therapy. Participants should have a body weight of at least 40 kg if they are between 12 and under 18 years old, and not be pregnant, breastfeeding, or planning pregnancy.

What is being tested?

The study is testing the effectiveness and safety of Upadacitinib compared to a placebo in treating atopic dermatitis. It's designed for those who require more than just skin creams or ointments due to the severity of their condition.

What are the potential side effects?

Potential side effects may include common cold symptoms, nausea, headaches, and potential increased risk of infection. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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

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I have had chronic eczema for over 3 years.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously taken medication that targets Janus kinase (JAK).

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I cannot or do not want to stop my current Alzheimer's treatments for this study.

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I do not need medications that are not allowed in the study.

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I do not have skin conditions or infections that need strong medication or could affect skin assessments.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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

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 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343

24%

UPPER RESPIRATORY TRACT INFECTION

24%

HYPERTENSION

18%

BRONCHITIS

12%

ACUTE RESPIRATORY FAILURE

12%

RASH

12%

URINARY TRACT INFECTION

12%

INFLUENZA

12%

FALL

12%

ARTHRALGIA

12%

WEIGHT INCREASED

12%

SINUSITIS

12%

MUSCLE SPASMS

12%

CHOLELITHIASIS

12%

NASOPHARYNGITIS

12%

LIVER FUNCTION TEST INCREASED

12%

OROPHARYNGEAL PAIN

DEHYDRATION

PNEUMONIA BACTERIAL

HEPATIC STEATOSIS

ASTHMA

NASAL CONGESTION

PULMONARY EMBOLISM

HYPONATRAEMIA

CONSTIPATION

RHINORRHOEA

BLOOD PRESSURE INCREASED

COUGH

BONE CONTUSION

HIP FRACTURE

VOMITING

PERIPHERAL SWELLING

STAPHYLOCOCCAL INFECTION

ORAL CANDIDIASIS

PNEUMONIA

FEELING HOT

HEADACHE

HAEMOGLOBIN DECREASED

COSTOCHONDRITIS

RHEUMATOID ARTHRITIS

PARAESTHESIA

PHOTODERMATOSIS

LEUKOCYTOSIS

TACHYCARDIA

HYPOKALAEMIA

STOMATITIS

PATELLA FRACTURE

ACTINIC KERATOSIS

GLAUCOMA

BACTERIAL SEPSIS

CHEST PAIN

FATIGUE

ATRIOVENTRICULAR BLOCK FIRST DEGREE

CANDIDA INFECTION

COVID-19

CATARACT

INFECTIOUS PLEURAL EFFUSION

SJOGREN'S SYNDROME

DYSPHAGIA

SWELLING

ACUTE KIDNEY INJURY

HERPES ZOSTER

OSTEOARTHRITIS

NAUSEA

NON-CARDIAC CHEST PAIN

RHINITIS

BLOOD CREATINE PHOSPHOKINASE INCREASED

FEMUR FRACTURE

LIGAMENT RUPTURE

SKIN LACERATION

SUPRAVENTRICULAR TACHYCARDIA

SCRATCH

SEBORRHOEIC KERATOSIS

EYE HAEMATOMA

INSOMNIA

ERYTHEMA

PRURITUS

DERMATITIS ALLERGIC

BACK PAIN

DIZZINESS

FLANK PAIN

SCIATICA

ANAEMIA

BILIARY COLIC

DERMATITIS CONTACT

DRUG HYPERSENSITIVITY

HERPES SIMPLEX

LOCALISED INFECTION

VULVOVAGINAL MYCOTIC INFECTION

DIABETES MELLITUS

VITAMIN D DEFICIENCY

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

OSTEOPENIA

PHARYNGITIS

100%

80%

60%

40%

20%

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Atopic Dermatitis (AD) include Janus kinase (JAK) inhibitors like upadacitinib, biologics such as dupilumab, and phototherapy. JAK inhibitors work by blocking the activity of specific enzymes (JAK1, JAK2) involved in the inflammatory process, thereby reducing the immune response that causes AD symptoms. Biologics like dupilumab target and inhibit specific cytokines (IL-4 and IL-13) that play a key role in the inflammatory pathways of AD. Phototherapy, particularly narrowband UVB, helps to reduce skin inflammation and can modulate the immune system. These treatments are crucial for AD patients as they address the underlying immune dysregulation, providing relief from severe symptoms and improving quality of life.