Topical Ruxolitinib Cream for Hidradenitis Suppurativa

Overseen By Andrea Zaenglein, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Milton S. Hershey Medical Center

Must not be taking: JAK inhibitors, Systemic corticosteroids

Disqualifiers: Active skin disease, Pregnancy, others

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 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 to determine its effectiveness in reducing symptoms of hidradenitis suppurativa (HS), a skin condition that causes painful lumps under the skin. Researchers aim to find out if the cream can effectively lower skin inflammation after 16 weeks of use. They will also analyze skin samples to understand the cream's impact on inflammation. Individuals with HS who have had the condition for at least three months and currently have active lesions may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

You may need to stop some medications, but others can be continued if they have been at a stable dose for a certain period. For example, biologic medications can be continued if stable for 6 months, oral antibiotics for 28 days, hormone-based therapy for 4 months, and oral retinoids for 90 days. However, other topical therapies must be stopped 14 days before the study starts.

Is there any evidence suggesting that ruxolitinib 1.5% cream is likely to be safe for humans?

Research has shown that ruxolitinib 1.5% cream is generally safe for patients. A combined safety review found few side effects over 32 weeks of use. Patients using the cream for hidradenitis suppurativa, a painful skin condition, did not experience any serious treatment-related issues.

These results suggest that the cream effectively reduces inflammation and symptoms of the condition. While all treatments carry some risk, current evidence indicates that ruxolitinib cream is likely safe for most people considering this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HS?

Unlike the standard treatments for hidradenitis suppurativa, which often involve antibiotics, corticosteroids, or surgical intervention, Ruxolitinib cream offers a unique approach by using a topical application of a Janus kinase (JAK) inhibitor. This cream specifically targets the JAK pathway, which is involved in the inflammatory process of the condition, potentially reducing inflammation more effectively. Researchers are excited about this treatment because it provides a non-invasive option that could minimize side effects associated with systemic therapies and offer improved symptom control directly at the site of flare-ups.

What evidence suggests that ruxolitinib 1.5% cream might be an effective treatment for hidradenitis suppurativa?

Research has shown that ruxolitinib cream 1.5% can help treat hidradenitis suppurativa (HS), a skin condition. In studies, participants using the cream experienced noticeable improvement in their symptoms. Specifically, scores measuring the severity of the condition dropped significantly. The cream reduces inflammation, a major component of HS. Most people find it easy to use and do not experience serious side effects. Overall, these findings suggest that ruxolitinib cream could be an effective treatment for HS. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 or older with Hidradenitis Suppurativa (HS), specifically Hurley Stage I or II. Participants must have active HS lesions in at least one area, a minimum of 3 inflammatory lesions, and a diagnosis of HS for at least 3 months. They should not have other skin conditions that could affect the study, be pregnant or lactating, and must agree to use contraception during the study.

Inclusion Criteria

My current medications have been stable and won't change during the study.

I had surgery in the treatment area more than 3 months ago.

I have Hidradenitis suppurativa at an early or moderate stage.

Exclusion Criteria

Does not have reliable internet access for weekly electronic surveys

I do not have any active skin conditions that could affect HS assessment.

Pregnant (or considering becoming pregnant) or lactating females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive topical Ruxolitinib 1.5% cream, twice daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib 1.5% Cream

Trial Overview The trial tests Ruxolitinib 1.5% cream's effectiveness on HS by reducing inflammation over a period of 16 weeks. It also examines how this topical treatment affects skin inflammation through analysis of biopsy samples from participants.

How Is the Trial Designed?

Group I: Open-label Experimental Treatment 1 Intervention

Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks

Ruxolitinib 1.5% Cream is already approved in United States, European Union for the following indications:

Approved in United States as Opzelura for:

• Atopic dermatitis
• Nonsegmental vitiligo

Approved in European Union as Opzelura for:

• Atopic dermatitis
• Nonsegmental vitiligo

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Incyte Corporation

Industry 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

Published Research Related to This Trial

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that causes painful lesions, and while there have been advancements in treatment, effective therapies are still needed.

Adalimumab is currently the only FDA-approved treatment for HS, but new biologics targeting specific inflammatory pathways are being tested in clinical trials, showing promise for future therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological development in hidradenitis suppurativa. Matusiak, Ł., Jemec, GB., Szepietowski, JC.[2020]

Ruxolitinib cream, a topical treatment for atopic dermatitis, was found to be generally well tolerated in a study of 41 patients aged 12 to 65, with only 31.7% experiencing treatment-emergent adverse events, and only 9.8% reporting treatment-related adverse events.

The cream demonstrated high efficacy, with 94.6% of patients achieving at least a 75% improvement in their eczema severity after 56 days of treatment, while the mean plasma concentration of the drug remained well below levels that could cause harmful effects on bone marrow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. Bissonnette, R., Call, RS., Raoof, T., et al.[2022]

Topical ruxolitinib has been shown to improve various dermatological conditions, including atopic dermatitis, vitiligo, psoriasis, and lichen planus, based on a review of 24 studies involving 2618 patients.

The safety profile of topical ruxolitinib is favorable, with minimal bioavailability and low rates of mild-to-moderate side effects, making it a more tolerable option compared to systemic Janus kinase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Topical Ruxolitinib in Dermatology: A Review. Kashetsky, N., Turchin, I.[2023]

Secukinumab, an anti-IL-17A monoclonal antibody, has been approved for treating moderate to severe Hidradenitis suppurativa (HS), marking a significant advancement in therapy for this chronic inflammatory skin disorder affecting 0.4% to 2.5% of the global population.

Clinical trials have demonstrated the safety and efficacy of secukinumab in HS, providing a new treatment option alongside the previously approved adalimumab, which targets a different inflammatory pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biology of Interleukin-17 and Novel Therapies for Hidradenitis Suppurativa. Sabat, R., Gudjonsson, JE., Brembilla, NC., et al.[2023]

Ruxolitinib cream 1.5% significantly improved disease severity, itching, and sleep disturbance in patients aged 12 and older with mild to moderate atopic dermatitis after 8 weeks of treatment, and continued to control symptoms for an additional 44 weeks when applied as needed.

The cream was well tolerated, with a safety profile similar to that of a placebo, and infrequent local side effects, making it a promising alternative to traditional treatments like corticosteroids for managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. Hoy, SM.[2023]

Ruxolitinib, a JAK1 and JAK2 inhibitor used for myelofibrosis and polycythemia vera, showed no carcinogenic potential in long-term studies with Tg.rasH2 mice and Sprague-Dawley rats, indicating it does not increase cancer risk.

Despite some pharmacological effects like lymphoid depletion and inflammation, ruxolitinib did not affect survival rates or increase neoplastic findings, suggesting it is safe for therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from oral gavage carcinogenicity studies of ruxolitinib in Tg.rasH2 mice and Sprague-Dawley (Crl:CD) rats. Shuey, DL., Oliver, J., Zhou, G., et al.[2021]

In two phase 3 studies involving 1249 patients with atopic dermatitis, ruxolitinib cream significantly improved treatment outcomes compared to a vehicle cream, with 93.4% of patients using the 0.75% formulation and 90.9% using the 1.5% formulation achieving clinically meaningful responses by week 8.

Patients who continued using ruxolitinib cream beyond 8 weeks showed progressive improvements, with over half achieving treatment success by week 52, indicating that extended therapy can provide additional benefits and that the cream was well tolerated throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically relevant improvements in adults and adolescents with atopic dermatitis who did not achieve Investigator's Global Assessment treatment success following 8 weeks of ruxolitinib cream monotherapy. Simpson, EL., Kircik, L., Blauvelt, A., et al.[2023]

In a review of 12 randomized controlled trials involving 2915 patients, adalimumab and bimekizumab were found to be effective treatments for moderate-to-severe hidradenitis suppurativa, showing significant improvement in clinical response compared to placebo at 12-16 weeks.

All evaluated biologics, including adalimumab, bimekizumab, and secukinumab, demonstrated similar safety profiles with no increased risk of adverse effects compared to placebo, making them viable options for patients with refractory hidradenitis suppurativa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. Tsai, YC., Hung, CY., Tsai, TF.[2023]

In two phase 3 trials involving 1249 patients with atopic dermatitis, ruxolitinib cream showed rapid and significant reductions in itch, with over 16% of patients experiencing a 2-point reduction within 12 hours compared to only 6.9% with the vehicle cream.

By Day 2, a greater percentage of patients using ruxolitinib cream achieved a 4-point reduction in itch severity, with sustained improvements observed over the 8-week treatment period, indicating both efficacy and a quick onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. Blauvelt, A., Kircik, L., Papp, KA., et al.[2023]

A systematic review of 34 publications involving 105 patients with hidradenitis suppurativa (HS) found that TNF-alpha inhibitors, particularly infliximab, led to positive treatment outcomes in 90% of cases, indicating their potential efficacy in managing this challenging skin condition.

While side effects were reported in 8 out of 105 patients, they were similar to those seen in other studies with TNF-alpha inhibitors, suggesting a manageable safety profile; however, the need for more standardized reporting and randomized controlled trials is emphasized to better understand long-term effects and optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. Haslund, P., Lee, RA., Jemec, GB.[2018]

Secukinumab, an IL-17A inhibitor, has shown promising efficacy in treating hidradenitis suppurativa, as demonstrated in the phase III SUNSHINE and SUNRISE clinical trials.

Unlike the currently FDA-approved treatment for hidradenitis suppurativa, adalimumab, which targets TNF-α, secukinumab offers a different mechanism of action that may benefit patients with this inflammatory skin condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab in the treatment of hidradenitis suppurativa. Snyder, CL., Gibson, RS., Porter, ML., et al.[2023]

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 ... The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa. Official Title. A Phase ...

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. 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.

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 ... Findings from the phase 2 trial show that ruxolitinib cream was generally well-tolerated and significantly reduced disease severity compared to ...

6. incytemi.com incytemi.com/document/Poster/Fall%20Clinical%202025_Bunick%20CG_Rux%20Cream%20Integrated%20Safety%20Analysis.pdf

Integrated Safety Analysis of Ruxolitinib Cream 1.5% ruxolitinib cream had an EAIR (95% CI) ... Ruxolitinib cream for mild-to-moderate hidradenitis suppurativa: 32-week data from a randomized ...

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

Ruxolitinib Study to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa. ClinicalTrials.gov identifier NCT05635838 ...

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 To assess the efficacy and safety of 1.5% ruxolitinib cream BID applied as needed through. Week 32 (OLE period) of the phase 2 study. Page 4 ...