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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 4 and 8
Awards & highlights
Study Summary
This trial is testing whether ruxolitinib cream is an effective and safe treatment for children with Atopic Dermatitis. The trial is double-blind, meaning that neither the participants nor the researchers will know who is receiving the active treatment or the placebo until the trial is over. The trial is also stratified, meaning that the participants will be divided into groups based on their age and severity of Atopic Dermatitis.
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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with Atopic Dermatitis.
Select...
I have a lesion larger than 5 cm2 not on my hands, feet, or genitalia.
Select...
My child is between 6 and 12 years old and often feels itchy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 2, 4 and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 4 and 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants who achieve Investigator's Global Assessment Treatment Success (IGA-TS)
Secondary outcome measures
Number of Treatment Emergent Adverse Events (TEAEs)
Proportion of participants who achieve EASI75 at Weeks 2, 4 and 8
Proportion of participants who achieve IGA-TS at Weeks 2 and 4
+5 moreSide effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
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
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Blood creatine phosphokinase increased
3%
Cystitis
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
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
~1140
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,836 Total Patients Enrolled
Brett Angel, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin condition affects 3% to 20% of my body, not including my scalp.My skin condition is only on my hands or feet and has not affected my face or folds of my skin.I have been diagnosed with Atopic Dermatitis.I have not taken antibiotics or antivirals for an infection in the last 2 weeks.I have a lesion larger than 5 cm2 not on my hands, feet, or genitalia.My child is between 6 and 12 years old and often feels itchy.You have other skin conditions or scarring that might make it difficult to assess the study's skin issues or could affect your safety.I use more than a high dose of asthma inhalers daily.I have used JAK inhibitors before, either as pills or creams.I have not had a skin infection in the week before my first visit.You have had Alzheimer's disease for at least 3 months.I have a type of eczema.My immune system is weakened.Your AD symptoms have been changing a lot in the past 4 weeks.I have not used any excluded treatments recently.You have tested positive for HIV.I haven't used UV light therapy or been exposed to much sunlight or tanning booths in the last 2 weeks.You have a specific score on a test called IGA, which means you may not be able to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Vehicle Cream
- Group 2: Ruxolitinib (1.5% Cream)
- Group 3: Ruxolitinib (0.75% cream)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being helped by this research?
"To begin this study, 250 eligible patients must enroll. These patients must meet the specific inclusion criteria for the study, and can come from different sites, such as Clinical Science Institute Clinical Research Specialists Inc in Santa Monica, California and Michigan Dermatology Institute in Waterford, Michigan."
Answered by AI
Are participants in this experiment restricted to adults over the age of eighteen?
"The age range for patients eligible to enroll in this clinical trial is 2-11 years old."
Answered by AI
What other drugs have been studied in conjunction with Ruxolitinib?
"Ruxolitinib was first studied in 2002 at the National Institutes of Health Clinical Center. So far, 111 trials have been completed with 100 more ongoing. The majority of these active trials are taking place in Santa Monica, California."
Answered by AI
For what purpose is Ruxolitinib most often prescribed?
"Ruxolitinib is a potential treatment for polycythemia vera and other issues such as hydroxyurea resistance or intolerance, and primary myelofibrosis."
Answered by AI
How can I participate in this clinical trial?
"This clinical trial is enrolling 250 participants with dermatitis aged 2 and 11. Most notable, candidates should meet the following criteria: Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior)., Participants with IGA score of 2 to 3 at the screening and baseline visits., Participants with %BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits., For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4., Participants/guardians who agree to discontinue"
Answered by AI
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