WILMINGTON, Del.--(BUSINESS WIRE)--Mar. 17, 2025-- Incyte (Nasdaq: INCY) today announced positive topline results from its pivotal Phase 3 STOP-HS clinical trial program evaluating the safety and efficacy of povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS)..

威尔明顿，特拉华州--(BUSINESS WIRE)--2025年3月17日--Incyte（纳斯达克股票代码：INCY）今天宣布了其关键的III期STOP-HS临床试验项目的积极初步结果，该试验评估了口服小分子JAK1抑制剂povorcitinib（INCB054707）在18岁及以上中重度化脓性汗腺炎（HS）成人患者中的安全性和有效性。

Both the STOP-HS1 and STOP-HS2 studies met their primary endpoint at both tested doses (45 mg and 75 mg). A significantly higher proportion of patients treated with povorcitinib once daily (QD) versus placebo achieved Hidradenitis Suppurativa Clinical Response (HiSCR), a ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.

两项研究（STOP-HS1 和 STOP-HS2）在两种测试剂量（45 毫克和 75 毫克）下均达到了主要终点。与安慰剂相比，每日一次 (QD) 使用 Povorcitinib 治疗的患者中有显著更高比例达到了化脓性汗腺炎临床反应 (HiSCR)，即总脓肿和炎性结节计数（AN 计数）较基线减少 ≥50%，且脓肿或引流隧道计数未较基线增加。

The percentage of povorcitinib treated patients achieving HiSCR50 compared to placebo at Week 12 was:.

第12周时，与安慰剂相比，达到HiSCR50的povorcitinib治疗患者百分比为：。

Within a predefined subgroup of patients previously exposed to biologics, povorcitinib demonstrated greater differential efficacy (HiSCR50) when compared to placebo (nominal

在先前接触过生物制剂的预定义患者亚组中，povorcitinib显示出比安慰剂更大的差异疗效（HiSCR50）（名义上）。

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In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares,

此外，在第12周时，接受povorcitinib治疗的患者达到了深度的临床反应水平，有更高比例的患者实现了HiSCR75，减少了病情发作，

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3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30. Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction.

皮肤疼痛数字评分量表 (NRS) 评分和皮肤疼痛 NRS30 下降 3 分。此外，povorcitinib 还展现了快速起效的特性，包括迅速减轻皮肤疼痛。

The overall safety profile of povorcitinib is consistent with previous data. No new safety signals were observed and both doses were well tolerated.

Povorcitinib 的总体安全性与之前的数据一致。未观察到新的安全信号，两种剂量均耐受良好。

'Hidradenitis suppurativa is a challenging and debilitating condition without a cure. Given the limitations of current HS treatments and its impact on patients’ daily lives, there is a critical need for new, well tolerated and effective therapies that provide a rapid reduction in the signs and symptoms of HS, in particular, pain,' said Steven Stein, M.D., Chief Medical Officer, Incyte.

“化脓性汗腺炎是一种具有挑战性且令人衰弱的疾病，目前尚无治愈方法。鉴于当前化脓性汗腺炎治疗方法的局限性及其对患者日常生活的影响，迫切需要新的、耐受性良好且有效的疗法，以快速减轻化脓性汗腺炎的体征和症状，特别是疼痛，”Incyte首席医学官Steven Stein博士说道。

'The positive Phase 3 data highlights the potential of povorcitinib as an effective oral treatment option for people living with HS.”.

“三期试验的积极数据突显了povorcitinib作为口服治疗HS患者的潜力。”

These data support the planned regulatory submission of povorcitinib for the treatment of HS worldwide. Additionally, data from both STOP-HS studies will be submitted for presentation at upcoming scientific meetings.

这些数据支持了计划在全球范围内提交povorcitinib治疗HS的监管申请。此外，来自两项STOP-HS研究的数据将会被提交并在即将到来的科学会议上展示。

About STOP-HS

关于STOP-HS

The STOP-HS clinical trial program includes two Phase 3 studies, STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836), evaluating the efficacy and safety of povorcitinib (INCB54707) in adult patients with moderate to severe HS. Both studies include a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week extension period and 30-day safety follow-up..

STOP-HS 临床试验计划包括两项 III 期研究，STOP-HS1（NCT05620823）和 STOP-HS2（NCT05620836），评估povorcitinib（INCB54707）在中度至重度HS成年患者中的疗效和安全性。两项研究均包括一个12周的双盲、安慰剂对照治疗期，随后是42周的延长期和30天的安全性随访。

The studies have each enrolled approximately 600 patients (age ≥18 years) diagnosed with moderate to severe HS for at least three months prior to the screening visit and meet certain criteria: total AN count of ≥5, lesions in at least two distinct anatomical areas, and have a documented history of inadequate response to at least a three-month course of at least one conventional systemic therapy (oral antibiotic or biologic drug) for HS, or have demonstrated intolerance to, or have a contraindication to, such conventional systemic therapies..

这些研究各自招募了大约600名患者（年龄≥18岁），这些患者在筛选访视前至少三个月被诊断为中度至重度HS，并符合某些标准：总AN计数≥5，至少两个不同解剖区域存在病灶，并有记录显示对至少一种常规系统治疗（口服抗生素或生物药物）的HS治疗至少三个月效果不佳，或表现出对该类常规系统治疗不耐受或存在禁忌症。

The primary endpoint for both studies is the proportion of patients who achieve HiSCR50, defined as at least a 50% reduction from baseline in the total AN count at Week 12, with no increase from baseline in abscess or draining tunnel count. Key secondary endpoints include the proportion of patients achieving a 75% reduction in AN count with no increase from baseline in abscess or draining tunnel count (HiSCR75) at Week 12, the proportion of patients experiencing at least one flare-up over 12 weeks, the proportion of patients with a .

两项研究的主要终点是实现HiSCR50的患者比例，定义为在第12周时总AN计数较基线至少减少50%，且脓肿或引流道计数没有较基线增加。关键的次要终点包括在第12周时AN计数减少75%且脓肿或引流道计数没有较基线增加（HiSCR75）的患者比例、12周内经历至少一次病情加重的患者比例、以及具有某一特定结果的患者比例。

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3-point decrease in the Skin Pain NRS score among those with a baseline score of ≥3, and the proportion of patients achieving a 30% reduction and at least 1-unit reduction from baseline in Skin Pain NRS at Week 12. The studies also evaluate the frequency and severity of adverse events during the study..

在基线评分为≥3的患者中，皮肤疼痛NRS评分降低3分，并且在第12周时皮肤疼痛NRS评分较基线减少30%且至少减少1分的患者比例。研究还评估了研究期间不良事件的频率和严重程度。

For more information on the STOP HS studies, please visit https://clinicaltrials.gov/study/NCT05620823 and https://clinicaltrials.gov/study/NCT05620836.

有关STOP HS研究的更多信息，请访问https://clinicaltrials.gov/study/NCT05620823 和 https://clinicaltrials.gov/study/NCT05620836。

About Hidradenitis Suppurativa

关于化脓性汗腺炎

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses that can lead to irreversible tissue destruction and scarring.

化脓性汗腺炎（HS）是一种慢性炎症性皮肤病，其特征是疼痛的结节和脓肿，可能导致不可逆的组织破坏和瘢痕形成。

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Over-activity of the JAK/STAT signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of HS.

JAK/STAT 信号通路的过度活跃被认为会驱动与 HS 发病机制和进展相关的炎症。

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More than 150,000 patients in the U.S. are estimated to have moderate to severe HS.

据估计，美国有超过15万名患者患有中度至重度的HS。

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Given the debilitating nature of the condition, it can have a profoundly negative effect on patients’ quality of life.

鉴于该疾病的衰弱特性，它可能对患者的生活质量产生极其负面的影响。

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About Povorcitinib

关于Povorcitinib

Povorcitinib (INCB54707) is an oral small-molecule JAK1 selective inhibitor currently in Phase 3 clinical trials for HS, vitiligo and prurigo nodularis (PN), as well as Phase 2 trials for asthma and chronic spontaneous urticaria (CSU).

Povorcitinib（INCB54707）是一种口服小分子JAK1选择性抑制剂，目前正在进行针对HS（化脓性汗腺炎）、白癜风和结节性痒疹（PN）的III期临床试验，以及针对哮喘和慢性自发性荨麻疹（CSU）的II期临床试验。

Incyte Forward-Looking Statements

Incyte前瞻性声明

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the regulatory submissions for povorcitinib worldwide; the submission of STOP-HS data for presentation at upcoming scientific meetings; the potential of povorcitinib to be an effective and well-tolerated treatment option for HS patients; and further clinical studies of povorcitinib, contain predictions, estimates and other forward-looking statements..

本新闻稿中包含的事项，除本文所载的历史信息外，包括关于 povorcitinib 在全球范围内的监管提交、为即将召开的科学会议提交 STOP-HS 数据、povorcitinib 成为 HS 患者有效且耐受性良好的治疗选择的潜力以及 povorcitinib 的进一步临床研究，包含预测、估计和其他前瞻性陈述。

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2024.

这些前瞻性陈述基于Incyte的当前预期，并受可能致使实际结果产生重大差异的风险和不确定性影响，包括与以下方面相关的意外发展和风险：意外延迟；进一步的研发工作及临床试验结果可能不成功或不足以满足适用监管标准或证明继续开发的合理性；在临床试验中招募足够数量受试者的能力；FDA及其他监管机构作出的决定；Incyte产品的有效性或安全性；Incyte产品在市场中的接受度；市场竞争；销售、营销、制造和分销要求；以及Incyte不时向证券交易委员会提交的报告中详细说明的其他风险，包括截至2024年12月31日年度的年报。

Incyte disclaims any intent or obligation to update these forward-looking statements..

Incyte否认有任何意图或义务更新这些前瞻性陈述。

Source: Incyte

来源：Incyte

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