Ruxolitinib Cream for Hidradenitis Suppurativa

Recruiting at 22 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Topical antibiotics, Systemic antibiotics

Disqualifiers: Cardiovascular disease, Thrombosis, Cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called ruxolitinib for people with hidradenitis suppurativa, a skin condition that causes painful lumps and bumps. The goal is to determine how effectively the cream can be applied to the affected skin areas. Suitable candidates for this trial have experienced hidradenitis suppurativa for at least six months and have lumps in at least three different body areas. Participants should not use other antibiotics while applying the cream during the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new 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 the study period. Other medications are not specifically 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 for safety in people with hidradenitis suppurativa, a skin condition that causes painful lumps. In one study, patients tolerated the cream well. Over 32 weeks, no serious safety issues arose, suggesting that ruxolitinib cream is generally safe. However, since this trial is in an early stage, it primarily focuses on assessing the safety and optimal use of the cream. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hidradenitis suppurativa, which often involve oral antibiotics or biologics, Ruxolitinib cream offers a topical approach. Researchers are excited about this treatment because it uses ruxolitinib, a Janus kinase (JAK) inhibitor, which targets inflammation directly in the skin. This is different from many current options that work systemically, potentially leading to fewer side effects. The cream's direct application to affected areas may also allow for quicker and more localized relief.

What evidence suggests that ruxolitinib cream might be an effective treatment for hidradenitis suppurativa?

Research has shown that ruxolitinib cream can help treat hidradenitis suppurativa, a painful skin condition. In an earlier study, patients using ruxolitinib cream 1.5% experienced a noticeable improvement in their symptoms. This cream blocks certain proteins, JAK1 and JAK2, that cause inflammation. Another study found that it reduced inflammation both on the skin's surface and in deeper layers. These studies suggest that ruxolitinib cream might help ease symptoms for people with this condition. Participants in this trial will apply ruxolitinib 1.5% cream topically to the affected area. ^{1 3 5 6 7}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

Adults and adolescents with Hidradenitis Suppurativa (HS) for at least 6 months, having at least 4 abscesses or nodules in 3 areas, and a body surface area affected over 20%. Participants must not use other HS antibiotics during the trial and should take precautions to avoid pregnancy or fathering children.

Inclusion Criteria

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

I agree not to become pregnant or father a child during the study.

I have been diagnosed with HS for at least 6 months.

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 applied topically to the affected area

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib Cream

Trial Overview The study is testing Ruxolitinib Cream's maximum safe usage on individuals with HS. It aims to understand how well the cream works when applied extensively across affected skin areas in participants who meet specific health criteria.

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.

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 ... Topical ruxolitinib decreased the inflammation seen on the skin's surface and also in the deeper layers. Our results support continued study on ...

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. 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 ...

6. hs-foundation.org hs-foundation.org/for-clinicians/prior-authorization-templates?download_file=eyJpZCI6IjEwMDg4NyJ9

Ruxolitinib 10. Study to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa. ClinicalTrials.gov identifier ...

7. 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.