What is the mechanism of action of this treatment?

Atopic Dermatitis (AD) treatments target the underlying inflammation and immune dysregulation characteristic of the disease. JAK inhibitors like Ruxolitinib work by blocking Janus kinase enzymes, which are involved in the signaling pathways that lead to inflammation. This helps reduce the immune response and inflammation in the skin. Topical corticosteroids suppress various inflammatory cytokines, providing rapid relief from inflammation and itching. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, thereby reducing inflammation without the side effects associated with steroids. Biologics like Dupilumab target specific molecules in the immune pathway, such as the IL-4 receptor, to reduce chronic inflammation and improve skin barrier function. These treatments are crucial for AD patients as they help manage symptoms, reduce flare-ups, and improve quality of life by addressing the root causes of the disease.

What side effects are associated with this type of intervention?

Common treatments for Atopic Dermatitis include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and JAK inhibitors (such as ruxolitinib cream). Topical corticosteroids can cause skin thinning, stretch marks, and increased risk of skin infections. Calcineurin inhibitors may lead to burning sensations, itching, and increased risk of skin infections. JAK inhibitors, like ruxolitinib cream, have been associated with mild side effects such as application site reactions, including redness and irritation, and more rarely, increased risk of infections. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, including topical corticosteroids, calcineurin inhibitors like tacrolimus and pimecrolimus, and more recently, biologics such as dupilumab, which targets the IL-4 receptor. Similar to Ruxolitinib Cream, which is a JAK inhibitor, the FDA has also approved other JAK inhibitors like delgocitinib for the treatment of Atopic Dermatitis. These treatments aim to reduce inflammation and manage symptoms effectively.

What other types of research exist?

Promising novel alternatives to Ruxolitinib Cream for Atopic Dermatitis patients include: 1) Abrocitinib, a JAK inhibitor, which has shown efficacy and safety in phase 3 trials. 2) Upadacitinib, another JAK inhibitor, demonstrated positive results in phase 3 trials. 3) Tralokinumab, an IL-13 inhibitor, has been effective in phase 3 trials when combined with topical corticosteroids. These treatments offer new options for patients with moderate-to-severe atopic dermatitis.

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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Eczema

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria

Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia

Must not have

Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit

Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 12 up to week 56

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medicated cream called ruxolitinib on children with Atopic Dermatitis, a skin condition that causes itching and redness. The cream works by calming the immune system and reducing inflammation. The study will check how well the cream works and if it is safe for extended use.

Who is the study for?

This trial is for children with Atopic Dermatitis (eczema) who've had it for at least 3 months. They need a lesion of at least 5 cm2 not on hands, feet, or genitalia and must stop other AD treatments during the study. Participants can't join if they have only hand/foot lesions, high-dose asthma treatment needs, previous JAK inhibitor use, skin infections before baseline visit, other eczema types or are immunocompromised.

What is being tested?

The trial tests Ruxolitinib cream's effectiveness and safety in treating children's eczema compared to a placebo (Vehicle Cream). It's randomized and double-blind; participants get either Ruxolitinib cream at two different strengths or placebo. After eight weeks of initial treatment efficacy check-up, there’s a long-term safety follow-up except those on placebo switch to active treatment.

What are the potential side effects?

Potential side effects may include application site reactions like redness or itching. Since Ruxolitinib is a JAK inhibitor, it could also affect the immune system leading to increased risk of infections. Long-term effects are being studied.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Atopic Dermatitis.

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I have a lesion larger than 5 cm2 not on my hands, feet, or genitalia.

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My child is between 6 and 12 years old and often feels itchy.

Exclusion Criteria

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

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I have not taken antibiotics or antivirals for an infection in the last 2 weeks.

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I use more than a high dose of asthma inhalers daily.

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I have used JAK inhibitors before, either as pills or creams.

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I have not had a skin infection in the week before my first visit.

Select...

My immune system is weakened.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 12 up to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 12 up to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 up to week 56 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8

Secondary study objectives

LTS Period: Number of Participants With Any Grade 3 or Higher TEAE

LTS Period: Number of Participants With Any TEAE

VC Period: Number of Participants With Any Grade 3 or Higher TEAE

+8 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

Anaemia

19%

Hypertension

17%

Nasopharyngitis

16%

Weight increased

14%

Herpes zoster

14%

Constipation

14%

Abdominal pain

14%

Headache

12%

Pruritus

12%

Back pain

12%

Epistaxis

12%

Pyrexia

12%

Dizziness

10%

Asthenia

10%

Fatigue

10%

Cough

10%

Oedema peripheral

10%

Arthralgia

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Peripheral artery thrombosis

Vertigo

Acute pulmonary oedema

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

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: Ruxolitinib (1.5% Cream)Experimental Treatment1 Intervention

Study drug will be administered twice daiily.

Group II: Ruxolitinib (0.75% cream)Experimental Treatment1 Intervention

Study drug will be administered twice daily.

Group III: Vehicle CreamPlacebo Group1 Intervention

Vehicle cream will be administered twice daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1170

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

Atopic Dermatitis (AD) treatments target the underlying inflammation and immune dysregulation characteristic of the disease. JAK inhibitors like Ruxolitinib work by blocking Janus kinase enzymes, which are involved in the signaling pathways that lead to inflammation. This helps reduce the immune response and inflammation in the skin. Topical corticosteroids suppress various inflammatory cytokines, providing rapid relief from inflammation and itching. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, thereby reducing inflammation without the side effects associated with steroids. Biologics like Dupilumab target specific molecules in the immune pathway, such as the IL-4 receptor, to reduce chronic inflammation and improve skin barrier function. These treatments are crucial for AD patients as they help manage symptoms, reduce flare-ups, and improve quality of life by addressing the root causes of the disease.