Ruxolitinib Cream for Hidradenitis Suppurativa

(TRuE-HS2 Trial)

Recruiting at 139 trial locations

Overseen By Incyte Corporation Call Center (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

450 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 for hidradenitis suppurativa, a skin condition that causes painful lumps. The trial aims to evaluate the cream's efficacy and safety in treating this condition. Participants will use either the ruxolitinib cream or a placebo cream, which lacks the active ingredient. The trial seeks individuals who have experienced hidradenitis suppurativa for at least six months, with mild to moderate symptoms affecting multiple body areas. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you do not use topical and systemic antibiotics or antiseptics on the affected areas during certain periods. It doesn't specify about other medications, so you should discuss your current medications with the study team.

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

Research has shown that ruxolitinib cream holds promise for treating conditions like hidradenitis suppurativa, particularly regarding safety. In earlier studies, patients using ruxolitinib cream 1.5% experienced a noticeable reduction in symptoms, indicating it is well-tolerated. These studies found no major safety issues.

Ruxolitinib cream targets certain proteins in the skin, helping to reduce swelling, redness, and pain. While every treatment carries some risks, past research suggests that ruxolitinib cream is generally safe. Prospective participants should consult a healthcare provider about potential risks before joining a trial. ^{1 2 3 4 5}

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

Ruxolitinib cream is unique because it offers a topical approach to treating hidradenitis suppurativa, a condition usually managed with systemic treatments like antibiotics and biologics. Unlike these standard treatments, which can have widespread effects on the body, ruxolitinib cream acts locally by inhibiting Janus kinase (JAK) pathways directly in the affected skin areas. This targeted action could potentially reduce inflammation with fewer side effects, making it a promising option for those seeking localized relief. Researchers are excited about its potential to provide an effective and safer alternative to current therapies.

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

Research has shown that ruxolitinib cream may help treat hidradenitis suppurativa. In this trial, participants will receive either ruxolitinib 1.5% cream or a vehicle cream as a placebo comparator. Studies have found that patients using the 1.5% cream experienced a greater reduction in symptoms based on a standard severity score. Specifically, one study found that 79.2% of patients saw at least a 50% decrease in the number of abscesses and nodules, a key sign of improvement. The cream blocks certain proteins that cause inflammation, helping to reduce symptoms. These findings suggest that ruxolitinib cream could be an effective treatment option for managing this condition. ^{1 2 3 6 7}

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. Participants must have a minimum of four inflammatory nodules and abscesses, affecting two different body areas. They cannot use topical or systemic antibiotics, nor antiseptic washes on HS lesions during the study.

Inclusion Criteria

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

My condition affects at least two different parts of my body.

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

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 Period

Participants may continue to receive treatment and be monitored for long-term outcomes

36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib Cream

Trial Overview The study tests ruxolitinib cream's effectiveness and safety against a placebo (vehicle cream) in treating HS. Participants will be randomly assigned to receive either the active medication or placebo to compare outcomes.

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. 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.

7. incytemi.com incytemi.com/document/Poster/AAD%202024%20Rux%20Cream%20in%20HS%20Study.pdf

Intended Use Efficacy and Safety of Ruxolitinib Cream in Patients With. Hidradenitis Suppurativa (Hurley Stage I and II):. Results From a Randomized ...