2024-517632-22-00招募中3 期
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 68
- 试验地点
- 34
- 主要终点
- The binary response status of HiSCR75 (defined as ≥ 75% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count) at Week 16.
研究概览
简要总结
To establish the efficacy of ruxolitinib 1.5% cream BID in participants with HS.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-Label Extension Period (OLE)
- 盲法
- Double (Carer, Investigator, Subject)
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Aged 12 years or older at screening.
- •Diagnosis of HS for at least 6 months before screening based on clinical history and physical examination, as performed by a dermatologist. 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.
排除标准
- •Body areas to be treated exceed 20% BSA at screening or baseline.
- •Use of any of the following treatments within the indicated washout period before Day 1 a. 12 weeks or 5 half-lives (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 1: Use of corticosteroid inhalers and intranasal sprays is allowed. Note 2: Use of oral corticosteroids for nondermatological conditions (eg, asthma exacerbation, bronchitis) is allowed for no longer than 7 days if deemed acceptable by the investigator and the sponsor (or designee). 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, retinoids, antihypertensives, antihyperglycemics, and antiandrogens such as acitretin, isotretinoin, metformin, spironolactone, and finasteride) with potential therapeutic impact. f. 2 weeks for systemic anti-infective 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). 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
- •Employees of the sponsor or investigator or otherwise dependents of them.
- •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
- •e. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, impetigo) within 2 weeks before Day
- •Current or history of any of the following conditions: a. Clinically 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 or arrythmia requiring therapy or uncontrolled hypertension (including elevated blood pressure (> 150 mmHg systolic or > 100 mmHg diastolic at screening and/or Day 1) unless approved by the medical monitor/sponsor. 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 (eg, 2 puffs BID of a 180-μg dose) or fluticasone > 440 μg/day (eg, 2 puffs BID of a 110-μg dose) 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.
结局指标
主要结局
The binary response status of HiSCR75 (defined as ≥ 75% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count) at Week 16.
The binary response status of HiSCR75 (defined as ≥ 75% reduction from baseline in total AN count with no increase from baseline in abscess or draining tunnel count) at Week 16.
次要结局
- Additional endpoints for EU–Treatment-IR Population: HiSCR75 at Week 16. The binary response status of ≥ 1 HS flare during the DBVC period. The binary response status of participants with baseline Skin Pain NRS score ≥ 3 who achieve Skin Pain NRS30 at Week 16. More endpoints in protocol.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (34)
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