Ruxolitinib Cream for Hidradenitis Suppurativa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cream, ruxolitinib, to evaluate its effectiveness and safety for individuals with hidradenitis suppurativa. This skin condition causes painful bumps or abscesses, often in areas like the armpits or groin. Participants will use either the ruxolitinib cream or a placebo cream to compare results. Individuals who have had hidradenitis suppurativa for at least 6 months and experience mild to moderate symptoms (without tunnels that drain) might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you do not use topical or systemic antibiotics for treating hidradenitis suppurativa during certain periods. It also asks you not to use topical antiseptics on affected areas during specific times. Other medications are not mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that ruxolitinib cream is likely to be safe for humans?
Research has shown that ruxolitinib cream has been tested in people with hidradenitis suppurativa, a condition that causes painful skin lumps. In earlier studies, participants using the 1.5% ruxolitinib cream experienced less severe symptoms.
Safety information from these studies indicates that the cream is generally well-tolerated. Some mild side effects occurred, but serious side effects were rare. This suggests that ruxolitinib cream is relatively safe for use.
Ruxolitinib is already FDA-approved in other forms for different conditions, which adds confidence to its safety. However, discussing any concerns with the medical team before joining a trial is important.12345Why do researchers think this study treatment might be promising for hidradenitis suppurativa?
Unlike the standard treatments for hidradenitis suppurativa, which often involve antibiotics or biologics, ruxolitinib cream is unique because it targets the Janus kinase (JAK) pathway. This cream is applied directly to the skin, offering a topical approach that could reduce systemic side effects associated with oral medications. Researchers are excited about its potential to provide a more targeted, localized treatment option that directly addresses inflammation, possibly leading to fewer side effects and more effective symptom control.
What evidence suggests that ruxolitinib cream might be an effective treatment for hidradenitis suppurativa?
Research has shown that ruxolitinib cream, which participants in this trial may receive, may effectively treat hidradenitis suppurativa (HS), a painful skin condition. In one study, 79.2% of patients using the cream experienced at least a 50% reduction in painful lumps and bumps, a key sign of improvement. Another study found that the cream helps reduce swelling, a major issue in HS. Ruxolitinib blocks certain proteins involved in the body's inflammation process. These findings suggest that ruxolitinib cream could be a helpful treatment for people with HS.12678
Who Is on the Research Team?
Incyte Study Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for individuals who have been diagnosed with hidradenitis suppurativa (HS) for at least 6 months. They should have a minimum of four inflammatory nodules and lesions in at least two different body areas, without any draining tunnels. Participants must agree not to use antibiotics or antiseptic treatments on HS lesions during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ruxolitinib 1.5% cream or vehicle cream, applied topically to the affected area
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to be monitored for long-term safety and efficacy
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