What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly Janus Kinase (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 treatments, such as topical corticosteroids, may also cause skin thinning and increased susceptibility to infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis (AD), including topical corticosteroids, calcineurin inhibitors like tacrolimus and pimecrolimus, and biologics such as dupilumab, which targets the IL-4/IL-13 pathway. Recently, Janus Kinase (JAK) inhibitors have emerged as a promising class of drugs for moderate to severe AD. Upadacitinib, a JAK inhibitor, is currently being studied for its efficacy and dosing flexibility in AD. Other JAK inhibitors, such as baricitinib and tofacitinib, have also shown potential in treating AD, offering new options for patients who do not respond adequately to traditional therapies.

What other types of research exist?

Promising novel alternatives to Upadacitinib for Atopic Dermatitis patients include Abrocitinib and Dupilumab. Abrocitinib, another JAK inhibitor, has shown significant efficacy in clinical trials. Dupilumab, an IL-4/IL-13 inhibitor, is already approved and has demonstrated long-term safety and efficacy in both adults and children with moderate to severe AD.

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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests how flexible the dosing of upadacitinib can be for adults with moderate to severe atopic dermatitis. Participants will take daily tablets for several months, and the study will monitor their response and any side effects. The goal is to find the best way to use this medication for people who need more than just skin creams. Upadacitinib is approved for the treatment of atopic dermatitis in adults and children older than 12 years whose disease is not adequately controlled with other treatments.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have had chronic eczema for over 3 years.

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I often feel severe itching.

Select...

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 • 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

PHARYNGITIS

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

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~11250

0 / 3Eligibility 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

Janus Kinase (JAK) inhibitors, such as upadacitinib, work by blocking the activity of one or more of the Janus kinase family of enzymes, which are involved in the signaling pathways that lead to inflammation. By inhibiting these pathways, JAK inhibitors reduce the inflammatory response that causes the symptoms of Atopic Dermatitis (AD), such as itching and rash. This is particularly important for AD patients who do not respond adequately to topical treatments, as systemic therapies like JAK inhibitors can provide more comprehensive control of the disease. Other common treatments include biologics like dupilumab, which target specific cytokines involved in the inflammatory process, and phototherapy, which uses ultraviolet light to reduce skin inflammation. These treatments are crucial for managing moderate to severe AD and improving patients' quality of life.