Amgen  and Kyowa Kirin Co., Ltd. announced new results from the ongoing ROCKET Phase III clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD)

安进和协和麒麟株式会社宣布了正在进行的ROCKET III期临床试验项目的最新结果，该项目正在评估研究性T细胞再平衡疗法rocatinlimab，该疗法靶向OX40受体，用于中度至重度特应性皮炎（AD）。

The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo. IGNITE was a 24-week, randomized, placebo-controlled, double-blind study to assess the efficacy, safety and tolerability of rocatinlimab monotherapy every 4 weeks in 769 adults with moderate to severe AD, including patients previously treated with a biologic or systemic Janus kinase (JAK) inhibitor medication..

IGNITE 研究评估了两种剂量的 rocatinlimab，达到了共同主要终点和所有关键次要终点，两种剂量的 rocatinlimab 均对比安慰剂实现了统计学显著性。IGNITE 是一项为期 24 周的随机、安慰剂对照、双盲研究，旨在评估每 4 周一次 rocatinlimab 单药治疗在 769 名中度至重度特应性皮炎（AD）成人患者中的疗效、安全性和耐受性，其中包括之前接受过生物制剂或系统性 Janus 激酶（JAK）抑制剂治疗的患者。

At week 24, 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo (p < 0.001). In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo (p < 0.001).

在第24周，高剂量组中有42.3%的患者实现了湿疹面积和严重程度指数评分（EASI-75）较基线减少≥75%，与安慰剂相比差异为29.5%（p < 0.001）。在低剂量组中，36.3%的患者达到了EASI-75，与安慰剂相比差异为23.4%（p < 0.001）。

In the higher dose group, 23.6% of patients achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1) at week 24, representing a 14.9% difference vs. placebo (p < 0.001). In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs.

在高剂量组中，23.6%的患者在第24周达到了经验证的研究者全球评估特应性皮炎（vIGA-AD）评分为0（清除）或1（几乎清除），并且较基线减少≥2分（vIGA-AD 0/1），与安慰剂相比差异为14.9%（p < 0.001）。在低剂量组中，19.1%的患者达到该终点，与安慰剂相比差异为10.3%。

placebo (p = 0.002)..

安慰剂 (p = 0.002)。

In addition, IGNITE met the endpoint of revised Investigator's Global Assessment (rIGA) score of 0/1 with a ≥2-point reduction from baseline, a more stringent measure of efficacy than vIGA-AD 0/1. At week 24, 22.7% of patients in the higher dose group achieved this endpoint, a 14.4% difference vs. placebo (p < 0.001).

此外，IGNITE 达到了修订的调查员全球评估（rIGA）评分为0/1且较基线减少≥2分的主要终点，这一疗效衡量标准比vIGA-AD 0/1更为严格。在第24周时，高剂量组中有22.7%的患者达到了这一终点，与安慰剂相比差异为14.4%（p < 0.001）。

In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo (p = 0.01)..

在较低剂量组中，16.3%的患者达到了这一终点，与安慰剂相比有8.0%的差异（p = 0.01）。

Across ROCKET program results to date, safety findings were generally consistent with the safety profile of rocatinlimab previously observed. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs.

在整个ROCKET项目迄今为止的结果中，安全性发现通常与之前观察到的罗卡替尼的安全性特征一致。在罗卡替尼组中，最常见的治疗出现的不良事件（≥5%）为发热、寒战和头痛。接受罗卡替尼治疗的患者中，出现这些不良事件的比例较高。

placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%..

安慰剂组出现胃肠道溃疡事件，总发生率不到1%。

The ROCKET program is also informed by the results of the SHUTTLE and VOYAGER studies. The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in 746 adults using the same co-primary endpoints as IGNITE, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths plus TCS/TCI versus placebo plus TCS/TCI at week 24..

ROCKET 项目还参考了 SHUTTLE 和 VOYAGER 研究的结果。SHUTTLE 研究在 746 名成人中评估了两种剂量的 rocatinlimab 联合外用皮质类固醇 (TCS) 和/或外用钙调神经磷酸酶抑制剂 (TCI) 的效果，采用与 IGNITE 相同的共同主要终点，成功达到了共同主要终点和所有关键次要终点，在第 24 周时，两种 rocatinlimab 剂量联合 TCS/TCI 均相较于安慰剂联合 TCS/TCI 取得了统计学显著性。

For EASI-75, 52.3% of patients in SHUTTLE's higher dose group achieved the endpoint, a 28.7% difference vs. placebo (p < 0.001), while 54.1% of patients in the lower dose group achieved the endpoint, a 30.4% difference vs. placebo (p<0.001).

对于EASI-75，SHUTTLE较高剂量组中有52.3%的患者达到了终点，与安慰剂相比差异为28.7%（p < 0.001），而较低剂量组中有54.1%的患者达到了终点，与安慰剂相比差异为30.4%（p < 0.001）。

For vIGA-AD 0/1, 26.1% of SHUTTLE patients in the higher dose group achieved the endpoint, a 13.8% difference vs. placebo (p<0.001). In the lower dose group, 25.8% of patients achieved the endpoint, a 13.5% difference vs. placebo (p<0.001).

对于vIGA-AD 0/1，较高剂量组中26.1%的SHUTTLE患者达到了终点，与安慰剂相比差异为13.8%（p<0.001）。在较低剂量组中，25.8%的患者达到了终点，与安慰剂相比差异为13.5%（p<0.001）。

For rIGA 0/1, 23.3% of SHUTTLE patients in the higher dose group achieved the endpoint, an 11.5% difference vs. placebo (p<0.001). In the lower dose group, 22.7% of patients achieved the endpoint, a 10.9% difference vs. placebo (p = 0.002). The higher rocatinlimab dose used in IGNITE and SHUTTLE was identical to the dose used in HORIZON..

对于rIGA 0/1，高剂量组中23.3%的SHUTTLE患者达到了终点，与安慰剂相比有11.5%的差异（p<0.001）。在低剂量组中，22.7%的患者达到了终点，与安慰剂相比有10.9%的差异（p = 0.002）。在IGNITE和SHUTTLE中使用的较高剂量的rocatinlimab与在HORIZON中使用的剂量相同。

The VOYAGER study successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.

VOYAGER 研究成功证明 rocatinlimab 不会干扰对破伤风和脑膜炎球菌疫苗的反应。

HORIZON, top-line results of which were previously shared, will be presented as a late-breaking abstract at the 2025 American Academy of Dermatology Annual Meeting. Results from IGNITE, SHUTTLE and VOYAGER will be presented at upcoming congresses or published in peer-reviewed journals.

HORIZON 的顶部结果此前已分享过，将会作为最新突破性摘要在 2025 年美国皮肤科学会年会上展示。 IGNITE、SHUTTLE 和 VOYAGER 的结果将会在即将召开的大会中展示或发表在同行评审的期刊上。

'Many patients with moderate to severe atopic dermatitis struggle with chronic, life-disrupting symptoms,' said  Dr. Jay Bradner, executive vice president of Research and Development at Amgen. 'Even with currently available therapies, they may fail to reach or maintain treatment goals. We're pleased with ROCKET program results to date, which support the potential of rocatinlimab as a new treatment option.'.

“许多中度至重度特应性皮炎患者都面临着慢性且影响生活的症状，”安进公司研发执行副总裁杰伊·布拉德纳博士表示。“即使在现有疗法的帮助下，他们可能仍然无法达到或维持治疗目标。我们对ROCKET项目迄今为止的结果感到满意，这些结果支持了rocatinlimab作为一种新治疗选择的潜力。”

'Looking ahead, the ASCEND trial will explore the effects of rocatinlimab beyond 24 weeks, including maintenance of clinical response with continued treatment or withdrawal, and the ASTRO and ORBIT trials will evaluate rocatinlimab in adolescent patients,' said Dr. Takeyoshi Yamashita,  senior managing executive officer and chief medical officer at Kyowa Kirin.

展望未来，ASCEND试验将探索罗卡替尼超出24周的效果，包括继续治疗或停药对临床反应的维持情况，而ASTRO和ORBIT试验将评估罗卡替尼在青少年患者中的效果。——协和麒麟高级常务执行官兼首席医学官山下武义博士表示。

'These findings will help define the full profile of rocatinlimab and its potential to inhibit and reduce pathogenic T cells.'.

“这些发现将有助于全面了解罗卡替尼单抗的特性及其抑制和减少致病性T细胞的潜力。”

Condition:

条件：

Atopic Dermatitis (Eczema)

特应性皮炎（湿疹）

Type:

类型：

drug

药物