/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ

/ -- 艾伯维（AbbVie，纽约证券交易所代码：ABBV）今天宣布了第二项关键性研究的积极顶线结果，该研究属于评估 upadacitinib（RINVOQ）安全性和有效性的 3 期 UP-AA 临床项目。

; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage).

；15毫克和30毫克，每日一次）用于患有严重斑秃（AA）的成年和青少年患者，其基线SALT评分平均为84.0（约16%的头皮覆盖率）。

In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p<0.001).

在研究1中，两种剂量的乌帕达西替尼均达到了主要终点，分别有45.2%和55.0%的患者在使用15毫克和30毫克乌帕达西替尼治疗后，在第24周达到了80%或更多的头皮毛发覆盖率（SALT评分≤20），而接受安慰剂的患者中仅有1.5%达到该标准（p<0.001）。

These results are consistent with the topline results previously

这些结果与之前公布的初步结果一致

announced

宣布

from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program.

来自第 3 阶段 UP-AA 临床项目的第一项平行重复研究（研究 2）。

'These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA,' said

“这些积极的结果增强了越来越多的证据，支持乌帕达西替尼改善AA患者生活的潜力，”

Kori Wallace

科里·华莱士

, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. 'We are very encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease.'.

医学博士、哲学博士、艾伯维公司副总裁兼全球免疫学临床开发主管表示：“我们对两种剂量的乌帕达西替尼在头皮和非头皮毛发再生方面观察到的改善感到非常鼓舞，并期待将这些数据提交给监管机构，这让我们离将乌帕达西替尼带给那些患有这种复杂免疫介导疾病的患者更近了一步。”

35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 0.7% of patients receiving placebo at week 24 (p<0.001).

分别有35.2%和45.8%的患者在接受15毫克和30毫克乌帕替尼治疗后达到了90%或以上的头皮毛发覆盖（SALT ≤ 10），而接受安慰剂治疗的患者在第24周时仅有0.7%达到此标准（p<0.001）。

Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT=0) with both doses of upadacitinib at week 24.

达到的其他关键次要终点包括眉毛和睫毛改善的受试者比例，以及在第24周时使用两种剂量的乌帕达西替尼达到头皮完全覆盖（SALT=0）的受试者比例。

'People living with AA often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options,' said

“尽管目前有治疗选择，但患有AA的人们常常面临与脱发严重程度和持续时间相关的极大不确定性，”

Arash Mostaghimi

阿里什·莫斯塔吉米

, M.D., M.P.A., M.P.H., associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women's Hospital,

医学博士、公共管理硕士、公共卫生硕士，布里格姆妇女医院皮肤科副教授、临床试验与创新副主任

Harvard Medical School

哈佛医学院

. 'These encouraging results are consistent with and reinforce the outcomes observed in the first pivotal trial. Together, these findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with this disease.'.

“这些令人鼓舞的结果与第一个关键试验中观察到的结果一致并对其进行了强化。这些发现共同强调了乌帕达西替尼在促进头发再生方面具有潜力，为那些承受这种疾病带来的心理社会负担的患者提供了希望。”

The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications.

在24周的安慰剂对照期（A期）中，两种剂量的乌帕替尼的安全性特征总体上与已批准适应症中观察到的一致。

Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group.

治疗中出现的严重不良事件分别发生在1.9%和1.8%的乌帕替尼15毫克和30毫克组患者中，而安慰剂组为0.7%。

Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 1.1% and 1.5% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group.

因治疗中出现的不良事件（TEAEs）而中断治疗的情况，在15 mg和30 mg乌帕替尼组中分别有1.1%和1.5%的患者发生，而安慰剂组中未出现。

The most common TEAEs observed were upper respiratory tract infection, acne, blood creatine phosphokinase increased and nasopharyngitis.

最常见的TEAE包括上呼吸道感染、痤疮、血液肌酸磷酸激酶升高和鼻咽炎。

Serious infections were reported infrequently with one in the placebo group and one in the upadacitinib 30 mg group, and none in the upadacitinib 15 mg group group.

严重感染报告频率较低，安慰剂组有一例，乌帕替尼30毫克组有一例，乌帕替尼15毫克组无病例。

There were no adjudicated MACE, adjudicated venous thromboembolic events or deaths reported.

没有报告裁决的主要不良心血管事件（MACE）、裁决的静脉血栓栓塞事件或死亡。

One malignancy (breast cancer) was reported in the upadacitinib 15 mg group.

在使用15毫克乌帕替尼的组中报告了一例恶性肿瘤（乳腺癌）。

Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

乌帕达西替尼在AA中的使用未经批准，其安全性和有效性尚未由监管机构评估。

About UP-AA Clinical Trial

关于UP-AA临床试验

UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata.

UP-AA M23-716 作为一项单一方案开展，包含两个重复的关键研究（研究 1 和研究 2），每个研究的随机化、研究中心、数据收集、分析和报告均独立进行。这两项三期随机、安慰剂对照、双盲研究评估了乌帕达西替尼在患有严重斑秃的成年及青少年受试者中的疗效和安全性。

In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks.

在研究1和研究2的A阶段，参与者被随机分配到三个组之一，接受15毫克乌帕替尼、30毫克乌帕替尼或安慰剂治疗24周。在研究1和研究2的B阶段，原本在A阶段随机分配到乌帕替尼剂量组的参与者将在B阶段继续相同的治疗28周。

Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based off of their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks.

在A阶段最初随机分配到安慰剂组的参与者，将根据他们在第24周的SALT评分，要么在B阶段继续使用安慰剂，要么被随机分配到两个组中的一个。总体而言，研究1和研究2的A阶段和B阶段共持续52周。完成研究1或研究2的参与者可以加入研究3，并可能被重新随机分配接受两种剂量的乌帕替尼中的一种，持续时间最长为108周。

The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (.

这两项试验在全球 248 个地点随机抽取了 1,399 名 12 至 64 岁的重度 AA 参与者。有关此试验的更多信息，请访问 www.clinicaltrials.gov。

NCT06012240

NCT06012240

About RINVOQ

关于RINVOQ

Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation..

由AbbVie科学家发现和开发的RINVOQ是一种JAK抑制剂，目前正被研究用于多种免疫介导的炎症性疾病。在人体白细胞细胞实验中，RINVOQ对JAK1以及JAK1/JAK3介导的细胞因子诱导的STAT磷酸化抑制作用比对JAK2/JAK2介导的STAT磷酸化更强。

The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

目前尚不清楚抑制特定 JAK 酶与治疗效果和安全性的相关性。

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.

乌帕达西替尼（RINVOQ）正在针对斑秃、化脓性汗腺炎、高安动脉炎、系统性红斑狼疮和白癜风进行三期临床试验。

About AbbVie

关于艾伯维

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

AbbVie的使命是发现并提供创新的药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们致力于在免疫学、肿瘤学、神经科学和眼科护理等多个关键治疗领域，以及我们Allergan Aesthetics产品组合中的产品和服务，对人们的生活产生显著影响。