24 Participants Needed

Topical Ruxolitinib Cream for Hidradenitis Suppurativa

JK
AZ
Overseen ByAndrea Zaenglein, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Milton S. Hershey Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

What data supports the effectiveness of the drug Ruxolitinib 1.5% Cream for treating hidradenitis suppurativa?

Ruxolitinib cream has shown effectiveness in treating atopic dermatitis, a skin condition, by reducing itchiness and improving skin condition. While it hasn't been specifically studied for hidradenitis suppurativa, its success in treating similar inflammatory skin conditions suggests it might be beneficial.12345

Is topical Ruxolitinib cream safe for use in humans?

Topical Ruxolitinib cream has been well tolerated in studies for conditions like atopic dermatitis, with a safety profile similar to a placebo cream and only infrequent mild skin reactions like stinging or burning. It has minimal absorption into the body, which supports its safety compared to oral forms of the medication.23567

How is Ruxolitinib cream different from other drugs for hidradenitis suppurativa?

Ruxolitinib cream is unique because it is a topical treatment, meaning it is applied directly to the skin, unlike other drugs for hidradenitis suppurativa that are usually injected or taken orally. This cream works by targeting specific pathways involved in inflammation, potentially offering a new approach for managing this condition.1891011

What is the purpose of this trial?

Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity.Investigators aim to:* Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment.* Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.

Eligibility Criteria

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.
See 6 more

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
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 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

Find a Clinic Near You

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 profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

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.
Secukinumab in the treatment of hidradenitis suppurativa.Snyder, CL., Gibson, RS., Porter, ML., 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.
Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis.Hoy, SM.[2023]
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.
A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis.Bissonnette, R., Call, RS., Raoof, T., et al.[2022]

References

Secukinumab in the treatment of hidradenitis suppurativa. [2023]
Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]
A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. [2022]
Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. [2023]
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. [2023]
Results from oral gavage carcinogenicity studies of ruxolitinib in Tg.rasH2 mice and Sprague-Dawley (Crl:CD) rats. [2021]
Utilization of Topical Ruxolitinib in Dermatology: A Review. [2023]
Biology of Interleukin-17 and Novel Therapies for Hidradenitis Suppurativa. [2023]
Pharmacological development in hidradenitis suppurativa. [2020]
Efficacy and Safety of Biologics and Small Molecules for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis. [2023]
Treatment of hidradenitis suppurativa with tumour necrosis factor-alpha inhibitors. [2018]
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