Ruxolitinib Cream for Hidradenitis Suppurativa

Recruiting at 128 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Antibiotics, Antiseptics

Disqualifiers: Infections, Cancer, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

400 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I agree not to use any antibiotics for HS during the initial study period.

I agree not to use antiseptic products on my HS lesions during specified study periods.

I meet other specific requirements for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ruxolitinib 1.5% cream or vehicle cream, applied topically to the affected area

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for long-term safety and efficacy

From Week 16 through Week 52

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib Cream

Trial Overview The study tests the effectiveness and safety of ruxolitinib cream compared to a vehicle (placebo) cream in treating HS. Participants will be randomly assigned to receive either the active medication or placebo, allowing researchers to measure true treatment effects against no active ingredients.

How Is the Trial Designed?

Group I: Ruxolitinib 1.5 % Cream Experimental Treatment 1 Intervention

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Group II: Vehicle Cream Placebo Group 1 Intervention

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

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

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-new-data-phase-2-study-evaluating-ruxolitinib

Incyte Announces New Data from Phase 2 Study ... Patients treated with ruxolitinib cream 1.5% showed a greater mean reduction in the International Hidradenitis Suppurativa Severity Score System ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06958211

NCT06958211 | Study to Evaluate the Efficacy and Safety ... Study Overview. The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39708369/

Pilot study of topical ruxolitinib demonstrates efficacy and ... Pilot study of topical ruxolitinib demonstrates efficacy and blunting of heterogeneous inflammatory processes in mild hidradenitis suppurativa.

4. touchderma.com touchderma.com/hidradenitis-suppurativa/conference-hub/topical-ruxolitinib-cream-mild-hidradenitis-suppurativa/

Encouraging results for topical 1.5% ruxolitinib cream in ... Ruxolitinib cream, a topical JAK1/JAK2 inhibitor, offers a potential novel treatment for milder cases of hidradenitis suppurativa (HS).

5. pharmacytimes.com pharmacytimes.com/view/a-new-study-finds-that-ruxolitinib-cream-1-5-is-effective-for-most-patients-with-hs

A New Study Finds That Ruxolitinib Cream 1.5% Is ... In the ruxolitinib arm, 79.2% of patients achieved at least a 50% reduction in AN count (AN50), which is also the criteria for achieving an ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20589033

Ruxolitinib Cream in Participants With Hidradenitis ... The primary purpose of this study is to assess the efficacy and safety of ruxolitinib 1.5% cream BID in participants with mild to moderate HS (Hurley Stage I or ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05635838

NCT05635838 | Study to Evaluate of the Efficacy and ... The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16 ...

8. incytemi.com incytemi.com/document/Poster/EADV%202024_Porter_32%20Wk%20Data%20from%20Phase%202%20Rux%20Cream%20in%20HS%20Study.pdf

32-Week Data From a Randomized Phase 2 Study Hidradenitis Suppurativa: 32-Week Data. From a ... To assess the efficacy and safety of 1.5% ruxolitinib cream BID applied as needed through.