Phase 3 Randomized Study of Ruxolitinib Cream in Adults with Hidradenitis Suppurativa
- Trial ID
- 2024-517633-40-00
- Protocol
- INCB018424-325
- Sponsor
- Incyte Corp.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to establish the **efficacy** of ruxolitinib 1.5% cream applied twice daily (BID) in participants with **Hidradenitis Suppurativa** (HS). This is clinically relevant as HS is a chronic inflammatory skin condition that significantly impacts patients' quality of life, and effective topical treatments are needed to manage symptoms and improve patient outcomes.
Secondary objectives include:
- Evaluating the treatment effect of ruxolitinib 1.5% cream BID in participants with HS.
- Further evaluating the treatment effect of ruxolitinib 1.5% cream BID in participants with HS.
- Assessing the safety and tolerability of ruxolitinib 1.5% cream BID in participants with HS.
Participants
The clinical trial involves a total of **389 participants** diagnosed with **Hidradenitis Suppurativa**. The study population includes both male and female subjects aged 12 years and older, encompassing a range of age categories. Participants were selected based on their ability to comprehend and sign an informed consent form, and they must have had a diagnosis of Hidradenitis Suppurativa for at least six months prior to screening. The trial includes individuals with mild to moderate disease severity, specifically those classified as Hurley Stage I or II, with a total abscess and nodule count of at least four, affecting at least two distinct anatomical areas. Participants are required to refrain from using topical or systemic antibiotics and certain antiseptics on affected areas during specified periods of the trial. The study population also includes vulnerable groups, ensuring a comprehensive evaluation of the treatment's efficacy across diverse demographics.
Plans and Procedures
The clinical trial is designed as a **randomized**, **double-blind**, vehicle-controlled study to evaluate the efficacy and safety of **Ruxolitinib** cream in participants with **Hidradenitis Suppurativa**. The trial will involve a comparison between the active treatment, Ruxolitinib cream, and a vehicle cream that lacks the active substance and phosphoric acid. The study is set to commence recruitment on September 12, 2025, and is expected to conclude by July 10, 2027, with a maximum treatment period of 52 weeks for participants.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis duration, and disease severity. The primary inclusion criteria require participants to be at least 12 years old, have a diagnosis of Hidradenitis Suppurativa for at least six months, and present with mild to moderate disease. The primary endpoint is the achievement of HiSCR75, defined as a 75% reduction from baseline in total AN count without an increase in abscess or draining tunnel count, assessed at Week 16.
Following the screening, participants will be randomized to receive either the Ruxolitinib cream or the vehicle cream. The trial includes a double-blind vehicle-controlled (DBVC) period, during which participants are required to refrain from using certain topical or systemic antibiotics and antiseptics. Follow-up visits will be conducted to monitor safety and efficacy, with assessments of secondary endpoints such as skin pain reduction and flare occurrence. The end-of-study visit will mark the completion of the participant's involvement, which is expected to last up to 52 weeks unless early termination is warranted.
Early termination from the study may occur if participants experience adverse events, fail to adhere to the study protocol, or withdraw consent. The trial aims to provide robust data on the efficacy of Ruxolitinib cream in treating Hidradenitis Suppurativa, contributing to the understanding of its therapeutic potential in this patient population.
Treatment
The clinical trial involves the use of **Ruxolitinib** (INCB018424) cream, which is an experimental medication formulated as a cream for **cutaneous use**. The active substance in this formulation is **Ruxolitinib**, a chemical compound. The cream is applied topically with a concentration of 1.5% and is administered twice daily (BID). The maximum daily dose is 8.6 grams, with a total maximum dose of 3130.4 grams over a treatment period of up to 52 weeks. The product is manufactured by Incyte Corporation and is identified by the sponsor product code INCB018424. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the treatment regimen.
The study also includes a **vehicle cream** as a non-experimental treatment, serving as a placebo comparator. This vehicle cream has the same formulation as the test product but lacks the active substance and phosphoric acid. It is also applied topically and is used to assess the efficacy and safety of the Ruxolitinib cream by providing a control for comparison. The vehicle cream is administered with the same frequency and route as the experimental cream, ensuring consistency in application across study participants. Compliance with the administration of the vehicle cream is similarly monitored to maintain the integrity of the trial results.
Efficacy
The efficacy of Ruxolitinib cream in the treatment of **Hidradenitis Suppurativa** will be assessed through a Phase 3, double-blind, randomized, vehicle-controlled study. The primary endpoint for evaluating efficacy is the binary response status of HiSCR75, defined as a ≥ 75% reduction from baseline in total abscess and nodule (AN) count with no increase from baseline in abscess or draining tunnel count, measured at Week 16. Secondary endpoints include the HiSCR75 response at Week 16 for the EU–Treatment-IR Population, the occurrence of ≥ 1 HS flare during the double-blind vehicle-controlled (DBVC) period, and the achievement of Skin Pain NRS30 at Week 16 for participants with a baseline Skin Pain Numeric Rating Scale (NRS) score of ≥ 3.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 12 years or older at screening.
- Diagnosis of HS based on clinical history and physical examination, as performed by a dermatologist, for at least 6 months before screening. Note: The study comprises participants with HS regardless of prior HS therapy, including both treatment-naive participants and treatment-IR participants (defined as those who had inadequate response, intolerance, or contraindication to prior topical or systemic medications for HS [excluding washes and antiseptics containing chlorhexidine, triclosan, iodine, etc]).
- Have mild to moderate HS (Hurley Stage I or II) with a total AN count of at least 4, with no draining tunnels, and affecting at least 2 distinct anatomical areas at the screening and Day 1 visits. Note: Anatomical areas include but are not limited to the left or right axilla, left or right inguinocrural fold, and left or right inframammary areas.
- Agreement to not use topical or systemic antibiotics for treatment of HS during the DBVC period and Weeks 16 through 20 of the OLE period.
- Agreement to not use topical antiseptics, including washes and leave-on products with ingredients such as chlorhexidine, povidone iodine, sodium hypochlorite, diluted bleach, or benzoyl peroxide, on the areas affected by HS lesions during the DBVC period and Weeks 16 through 20 of the OLE period. Note: Over-the-counter soap and water are allowed.
- Willingness to avoid pregnancy or fathering children based on the criteria below. Refer to protocol for all details.
Exclusion Criteria
- Body areas to be treated exceed 20% BSA at screening or baseline.
- Presence of any draining tunnel(s) at screening or baseline.
- Any of the following conditions: a. Any other concomitant skin disorder that may interfere with and confound the evaluation of HS or compromise participant safety. b. Current and/or history of active TB . Or current and/or history of latent TB unless adequately treated. c. Immunocompromised (eg, lymphoma, immunosuppression associated with organ transplantation, Wiskott-Aldrich syndrome). d. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1. e. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, impetigo) within 2 weeks before Day 1.
- Current or history of any of the following conditions: a. Uncontrolled cardiovascular disease, including unstable angina, myocardial infarction, coronary artery disease, ischemic heart disease, or New York Heart Association Class III or IV congestive heart failure, as well as uncontrolled arrhythmia, atrial fibrillation, arrythmia requiring therapy or uncontrolled hypertension including elevated blood pressure (> 150 mmHg systolic or > 100 mmHg diastolic at screening and/or Day 1). When in doubt, the investigator should consult the medical monitor to confirm eligibility. b. Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, or stroke. c. Severe anemia, severe thrombocytopenia, or severe neutropenia. d. Any malignancies or history of malignancies within 5 years before Day 1, except for adequately treated, nonmetastatic, nonmelanoma skin cancer. e. Unstable asthma or COPD requiring systemic treatment (such as intravenous corticosteroids) or hospital admission or emergency department treatment within 3 months before Day 1 or stable asthma or COPD requiring budesonide > 720 µg/day or fluticasone > 500 μg/day or other equivalent inhaled corticosteroids. f. Any serious illness or medical, physical, or psychiatric condition that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with the interpretation of study data. When in doubt, the investigator should consult with the medical monitor to clarify eligibility.
- Any of the clinical laboratory test results at screening defined in protocol.
- Positive for HIV antibody.
- Current, acute or chronic, active HBV or HCV infection. Participants who have recovered or have been successfully treated with no evidence of active HBV or HCV infection and those who are immune due to hepatitis B vaccination can enroll. Participants who are positive for HBsAg will be eligible if they are negative for HBV DNA; participants who are positive for the anti-HCV antibody will be eligible if they are negative for HCV RNA.
- Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
- History of treatment failure (as assessed by the investigator through participant interview) for HS with any systemic or topical JAK inhibitor.
- Use of any of the following treatments within the indicated washout period before Day 1 a. 12 weeks or 5 halflives (if known), whichever is longer, for systemic immunosuppressive or immunomodulating biologic drugs (eg, adalimumab, anakinra, bermekimab, bimekizumab, brodalumab, certolizumab, dupilumab, etanercept, golimumab, guselkumab, infliximab, iscalimab, ixekizumab, risankizumab, rituximab, secukinumab, vilobelimab, ustekinumab). b. 4 weeks for any topical or systemic JAK or TYK2 inhibitor (eg, abrocitinib, baricitinib, brepocitinib, delgocitinib, deucravacitinib, filgotinib, lestaurtinib, pacritinib, ruxolitinib, tofacitinib, upadacitinib). c. 4 weeks for systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate, tacrolimus). Note: Use of corticosteroid inhalers and intranasal sprays is allowed. d. 4 weeks for surgical, laser, or any phototherapy intervention in areas with HS lesions. e. 2 weeks for other systemic therapies for HS (eg, zinc, vitamin D, retinoids, antihypertensives, antihyperglycemics, and antiandrogens such as acitretin, isotretinoin, metformin, spironolactone, and finasteride) with potential therapeutic impact. f. 2 weeks for systemic antiinfective therapy for HS. g. 2 weeks for intralesional therapy for HS. h. 2 weeks for any topical therapy for HS (eg, topical antiseptics such as chlorhexidine, benzoyl peroxide, sodium hypochlorite, povidone iodine, or benzoyl peroxide; topical antibiotics; topical corticosteroids; topical calcineurin inhibitors; or other topicals). Note: Use of topical therapy for dermatologic diseases other than HS (eg, AD, psoriasis) is allowed for areas not being treated for HS. The total BSA involvement for other dermatologic diseases should not interfere with the safety of the participant or the HS assessments. i. 2 weeks or 5 half-lives, whichever is longer, for strong systemic CYP3A4 inhibitors. j. 2 weeks for immunizations with live-attenuated vaccines. Note: Non–live-attenuated vaccinations (eg, flu, COVID-19) are allowed. k. 2 weeks for any opioid treatment. l. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before Day 1 with another investigational medication, or current enrollment in another investigational drug study.
- Undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- Known allergy or reaction to any of the components of the study cream formulation and/or products in the same class.
- History of active alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
- Pregnant or lactating.
- Currently hospitalized or history of hospitalization for mental health indication within 12 months.
- In the opinion of the investigator, unable or unlikely to comply with the application schedule, study evaluations, or procedures (eg, eDiary compliance).
- In the EU, participants considered incapacitated according to CTR Article 31.
- Employees of the sponsor or investigator or otherwise dependents of them.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Not Recruiting | 12 Sept 2025 | 6 |
 Bulgaria | Not Recruiting | 12 Sept 2025 | 17 |
 France | Not Recruiting | 12 Sept 2025 | 13 |
 Germany | Not Recruiting | 12 Sept 2025 | 19 |
 The Netherlands | Not Recruiting | 12 Sept 2025 | — |
 Poland | Not Recruiting | 12 Sept 2025 | 22 |
 Spain | Not Recruiting | 12 Sept 2025 | 23 |
| Netherlands | — | — | 6 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Vehicle creamsame formulation of cream as the test product but without active substance and the phosphoric acid | Placebo | N/A | — | — | — | N/A |
Ruxolitinib (INCB018424) cream | Test | CREAM | CUTANEOUS USE | 8.6 | 52 | PRD10399242 |