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Janus Kinase (JAK) Inhibitor

Topical Ruxolitinib Cream for Hidradenitis Suppurativa

Phase 2
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Hidradenitis suppurativa, and should be Hurley Stage I or II, defined as papules, nodules, and/or abscess formation, single or multiple, with or without sinus tracts
Negative TB screening assessment (including a PPD test and/or Quantiferon-TB Gold test equivalent) OR for patients with treated latent TB or negative chest x-ray (CXR posterior-anterior [PA] and lateral view within prior 90 days) at Screening with documentation of treated latent tuberculosis (90 days of treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.
Awards & highlights

Study Summary

This trial is testing whether a cream containing the drug ruxolitinib can reduce disease activity in people with HS. Investigators will also study how this drug affects inflammation by looking at skin biopsy samples.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include local reactions like itching or rash where the cream is applied since it targets inflammatory activity in the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Hidradenitis suppurativa at an early or moderate stage.
Select...
I have tested negative for TB or have completed treatment for latent TB.
Select...
I have active skin lesions in at least one area of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HiSCR

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib 1.5% Cream
2022
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,818 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,165 Total Patients Enrolled
7 Trials studying Hidradenitis Suppurativa
2,483 Patients Enrolled for Hidradenitis Suppurativa

Media Library

Ruxolitinib 1.5% Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04414514 — Phase 2
Hidradenitis Suppurativa Research Study Groups: Open-label
Hidradenitis Suppurativa Clinical Trial 2023: Ruxolitinib 1.5% Cream Highlights & Side Effects. Trial Name: NCT04414514 — Phase 2
Ruxolitinib 1.5% Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04414514 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies is Ruxolitinib 1.5% Cream most frequently deployed to combat?

"Ruxolitinib 1.5% Cream is commonly utilized for polycythemia vera, as well as other maladies that are resistant or intolerant to hydroxyurea, such as primary myelofibrosis and polycythemia."

Answered by AI

To what extent does using Ruxolitinib 1.5% Cream pose a risk to individuals?

"The safety of Ruxolitinib 1.5% Cream was assessed to be a 2, as it is currently in Phase 2 trials and there are some data indicating its safety but yet no efficacy reports."

Answered by AI

How many individuals have enrolled to participate in this clinical investigation?

"Affirmative. According to the clinicaltrials.gov database, this scientific experiment is currently in its patient recruitment phase. It was initially posted on November 1st 2022 and lasted edited July 28th 2022; 24 subjects are expected to join from a single research centre."

Answered by AI

Is this study enrolling new participants presently?

"Affirmative. According to clinicaltrials.gov, this trial was first announced on November 1st 2022 and is currently seeking eligible participants for the study. 24 volunteers are required from a single medical centre."

Answered by AI
~5 spots leftby Oct 2024