Ruxolitinib Cream for Eczema
(TRuE-AD5 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a cream called ruxolitinib to determine its safety and effectiveness for children and teens with moderate atopic dermatitis, a type of eczema that causes red, itchy skin. Participants will apply either the cream or a placebo (a cream with no active medicine) and report their symptoms. The trial seeks children and teens who have had eczema for at least a few months or years, experience frequent flare-ups, and have not found success with other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
Yes, participants must stop using all agents to treat eczema from the screening visit through the final safety follow-up visit, except as outlined in the protocol. There are specific washout periods for certain medications, such as 4 weeks for systemic corticosteroids and 1 week for other topical treatments for eczema.
Is there any evidence suggesting that ruxolitinib cream is likely to be safe for children and adolescents with eczema?
Research has shown that ruxolitinib cream is generally safe for treating atopic dermatitis, a common skin condition, in children and teens. In earlier studies, the cream was used for up to a year and was usually well tolerated without causing serious side effects. Many people with mild to moderate atopic dermatitis found it effective.
Safety data from a year after the cream's approval indicate that it doesn't cause major health issues. Studies over eight weeks also confirmed its safety and effectiveness. After 44 weeks of use, more than two-thirds of patients had clear or nearly clear skin. These findings suggest that ruxolitinib cream is a safe option for managing eczema symptoms.12345Why do researchers think this study treatment might be promising for eczema?
Ruxolitinib cream stands out in eczema treatment because it targets the JAK-STAT pathway, a key player in the inflammatory process that drives eczema. Most existing treatments for eczema, like topical corticosteroids and calcineurin inhibitors, focus on reducing inflammation through different pathways. Ruxolitinib's unique mechanism allows it to directly interfere with the signaling that leads to inflammation, potentially offering a more targeted and effective approach. Researchers are excited because this could mean faster relief and better management of eczema symptoms with potentially fewer side effects than traditional options.
What evidence suggests that ruxolitinib cream might be an effective treatment for eczema?
Studies have shown that ruxolitinib cream effectively treats eczema, particularly atopic dermatitis. Earlier trials demonstrated that the cream significantly reduced symptoms such as eczema and itching in patients with mild to moderate conditions. By the second week of use, patients experienced less discomfort, and improvements continued for up to a year. Another study found that more than two-thirds of participants had clear or almost clear skin after using the cream consistently for 44 weeks. In this trial, participants will receive either ruxolitinib cream or a vehicle cream as a comparator. These findings suggest that ruxolitinib cream can be a strong option for managing eczema symptoms.45678
Who Is on the Research Team?
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for children and adolescents aged 6 to less than 18 with moderate atopic dermatitis (eczema). They must have a history of inadequate response to skin treatments, meet specific criteria for disease severity and duration, and have a certain level of itchiness. Those who've had systemic treatment or phototherapy can also join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vehicle-controlled (VC) Period
Participants receive either ruxolitinib cream or vehicle cream twice daily to assess efficacy and safety
Disease Control (DC) Period
Participants receive ruxolitinib cream or vehicle cream twice weekly to manage disease exacerbations
Open-label Extension (OLE) Period
Participants may continue receiving ruxolitinib cream twice daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ruxolitinib Cream
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School