Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis.

开始日期2024-08-13

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

NCT06531109 / RecruitingN/A

PRESTO - Characterization and Clinical Outcomes of Alopecia Areata (AA) Patients Treated With Ritlecitinib in a Real-world (RW) Cohort: A Multinational, Prospective Observational Study.

Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are:
* Patchy alopecia (PA), as seen in 90% of clinical diagnoses
* Alopecia totalis (AT), that affects all scalp hair
* Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020).
Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally.
Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib.
The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.

开始日期2024-08-07

申办/合作机构

Pfizer Inc.

NCT06573593 / RecruitingN/AIIT

Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study

The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.

开始日期2024-07-29

申办/合作机构

Second Affiliated Hospital Zhejiang University College of

100 项与甲苯磺酸利特昔替尼相关的临床结果

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100 项与甲苯磺酸利特昔替尼相关的转化医学

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100 项与甲苯磺酸利特昔替尼相关的专利（医药）

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项与甲苯磺酸利特昔替尼相关的文献（医药）

2024-11-01·JOURNAL OF DERMATOLOGY

Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis

Article

作者: Magnolo, Nina ; Takiya, Liza ; Wajsbrot, Dalia ; Schaefer, Gregor ; Guttman‐Yassky, Emma ; Mesinkovska, Natasha ; King, Brett ; Wolk, Robert ; Sinclair, Rodney ; Cox, Lori Ann ; Kerkmann, Urs ; Banerjee, Anindita ; Peeva, Elena ; Mizuashi, Masato ; Law, Ernest ; Zhang, Xingqi ; Shapiro, Jerry

Abstract:

This post‐hoc analysis of the ALLEGRO phase 2b/3 study (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral Janus kinase 3/TEC family kinase inhibitor, in patients with alopecia totalis (AT) and alopecia universalis (AU). Patients aged ≥ 12 years with alopecia areata (AA) and ≥50% scalp hair loss received once‐daily ritlecitinib 50 or 30 mg (± 4‐week 200‐mg loading dose) or placebo for 24 weeks. In a subsequent 24‐week extension period, the ritlecitinib groups continued their doses and patients initially assigned to placebo switched to ritlecitinib (200/50 or 50 mg daily). In this analysis, clinician‐ and patient‐reported hair regrowth outcomes were assessed at weeks 24 and 48 in four AA subgroups: AT/AU, AT, AU, and non‐AT/AU. Safety was monitored throughout. Of the 718 randomized patients, 151 (21%) and 147 (20%) were defined as having AT or AU, respectively. At week 24, Severity of Alopecia Tool (SALT) score ≤20 (≤20% scalp hair loss) response rates were higher in the ritlecitinib‐treated AT/AU, AT, and AU groups (7%–14%, 7%–21%, and 4%–10%, respectively) vs the placebo group (0% in the AT/AU, AT, and AU groups). The proportions of patients with a SALT score of ≤20 increased through week 48 (AT/AU, 13%–31%; AT, 11%–27%; AU, 6%–41%). Additionally, at week 24, 25%–43%, 32%–42%, and 12%–50% of patients with AT/AU, AT, and AU, respectively, who received ritlecitinib achieved a moderately or greatly improved response based on the Patient Global Impression of Change scale. Response rates generally increased through week 48 and were similar across AA subgroups. In patients with AT/AU, ritlecitinib was well tolerated with a safety profile consistent with that of the overall AA population. Ritlecitinib demonstrated clinical efficacy, patient‐reported improvement, and an acceptable safety profile in patients with AT and AU through week 48. A plain language summary of this study is available at https://doi.org/10.25454/pfizer.figshare.26879161. Clinicaltrials.gov: NCT03732807.

2024-10-01·Dermatology and Therapy

Impact of Previous Alopecia Areata Treatment on Efficacy Responses up to Week 48 Following Ritlecitinib Treatment: A Post Hoc Analysis

Article

作者: Nagra, Ranjit ; Holmes, Susan ; Fu, Jennifer ; Edwards, Roger ; Egeberg, Alexander ; Bonfanti, Gianluca ; Law, Ernest ; Vano-Galvan, Sergio ; Tran, Helen ; Steinhoff, Martin ; Wolk, Robert

INTRODUCTION:

Patients with alopecia areata (AA) may have received several therapies for management of AA during their lives. In the ALLEGRO phase 2b/3 (NCT03732807) study, the oral JAK3/TEC family kinase inhibitor ritlecitinib demonstrated efficacy and an acceptable safety profile in patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss. This post hoc analysis investigated associations between prior use of AA therapies and Severity of Alopecia Tool (SALT) responses in patients receiving ritlecitinib for AA.

METHODS:

Patients receiving ritlecitinib 30 mg or 50 mg once daily with or without an initial 4-week 200-mg daily loading dose were grouped by previous exposure to AA treatments, including topicals, intralesional corticosteroids (ILCS), topical immunotherapy, and systemic immunosuppressants or any prior AA treatment. Multivariable logistic regression analyses evaluated the association between response based on a SALT score of ≤ 20 and any prior treatment for AA at weeks 24 and 48.

RESULTS:

Of 522 patients, 360 (69.0%) had previous exposure to any AA treatment. At Week 24, SALT ≤ 20 response was positively associated with prior use of ILCS (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.23-3.65; P < 0.05) and negatively associated with prior use of systemic immunosuppressants (OR 0.50; 95% CI 0.28-0.88; P < 0.05). Prior use of topicals or topical immunotherapy was not associated with SALT ≤ 20 response at Week 24. By Week 48, no association was identified between SALT ≤ 20 response and prior use of topicals, ILCS, topical immunosuppressants, or systemic immunosuppressants (all P > 0.05). Previous exposure to any AA therapy was not associated with SALT ≤ 20 response at weeks 24 or 48 (all P > 0.05).

CONCLUSIONS:

Prior AA treatment history had no effect on longer-term treatment response to ritlecitinib.

TRIAL REGISTRATION NUMBER:

NCT03732807.

2024-10-01·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Sustained hair regrowth with continued ritlecitinib treatment through Week 48 in patients with alopecia areata with or without early target responses: post hoc analysis of the ALLEGRO phase 2b/3 trial

Article

作者: Senna, Maryanne ; Lynde, Charles ; Wajsbrot, Dalia ; Ahmed, Haytham Mohamed ; Takiya, Liza ; King, Brett ; Piliang, Melissa ; Zwillich, Samuel H ; Tran, Helen ; Sinclair, Rodney ; Wolk, Robert ; Zwillich, Samuel H. ; Mirmirani, Paradi ; Forman, Seth ; Bordone, Lindsey ; De La Cueva Dobao, Pablo

BACKGROUND:

Few treatments for alopecia areata (AA) have demonstrated sustained efficacy.

OBJECTIVE:

Evaluate the efficacy and safety of continued ritlecitinib treatment to Week 48 in patients with AA with or without target efficacy responses at Week 24.

METHODS:

Patients aged ≥12 years received daily ritlecitinib (± 4-week loading dose): 200/50 mg, 200/30 mg, 50 mg, or 30 mg. Patients with clinical response at Week 24, based on a Severity of Alopecia Tool (SALT) score ≤20 and ≤10 were evaluated for sustained response through Week 48. Nonresponders at Week 24 were assessed for response through Week 48.

RESULTS:

Among ritlecitinib-treated patients with SALT score ≤20 and ≤10 responses at Week 24, ≥85% and ≥68%, respectively, sustained these responses through Week 48. Of those with SALT score >20 at Week 24, 22%-34% achieved SALT score ≤20 at Week 48. Of those with a SALT score >10 at Week 24, 20%-26% achieved SALT score ≤10 at Week 48. Safety was similar across subgroups.

LIMITATIONS:

Small sample size.

CONCLUSION:

Hair regrowth was sustained through Week 48 in patients with response at Week 24. Up to one-third of patients who did not meet target efficacy at Week 24 achieved response with continued ritlecitinib treatment.

232

项与甲苯磺酸利特昔替尼相关的新闻（医药）

2024-10-25

·PRNewswire

Sun Pharma Presents LEQSELVI™ (deuruxolitinib) Data Highlighting Clinical Efficacy & Durability for Treatment of Alopecia Areata at the 2024 Fall Clinical Dermatology Conference

Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). "This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata," said Brett King, MD, PhD. "These data highlight an important role for deuruxolitinib in the care of patients living with this disease." In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option. "As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option." LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com. About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果上市批准

2024-10-22

·精准药物

JAK抑制剂的新机遇

作者｜小鱼摘要：在自免领域，JAK抑制剂的疗效通常优于生物制剂，然而不良事件限制了JAK抑制剂的使用。由于不良事件大多与JAK抑制剂选择性不足有关，因此当前JAK抑制剂的发展机遇是提高对疾病相关JAK（Janus激酶）通路的特异性选择性，以优化治疗效果并减少副作用。正文： Janus激酶（JAKs）是一个磷酸转移酶家族，成员有JAK1、JAK2、JAK3、TYK2，最初发现于20世纪90年代早期，由于具有串联的激酶结构域，使它们成为许多细胞因子信号传导的合理靶点。由JAKs传导的细胞因子在免疫介导疾病的发病机制中具有重要作用。图1 Janus激酶的功能自2010年以来，多种JAK抑制剂已被批准用于自身性免疫疾病、炎症等适应症。图2 JAK抑制剂开发的时间表文中论证了JAK抑制剂的自免治疗优势，并讨论了JAK抑制剂的选择性的问题及其在不良事件方面的相关性，并描述了JAK靶向的新模式，以及JAK抑制剂作用的新方面。要点速览： ● JAK抑制剂在几种自身免疫性疾病中，与bDMARDs（生物制剂疾病缓解抗风湿药，包括依那西普、英夫利西单抗、阿达木单抗、托珠单抗等）相比，表现出同等或优越的疗效。 ● JAK抑制剂的使用一直受到不良事件的阻碍，这可能与被阻断的JAK有关。 ● 组织靶向JAK抑制剂可以规避全身给药导致的不良事件。 ● 用小干扰RNA或代谢物衍生物抑制JAK的替代策略是热门领域。 01 JAK抑制剂治疗自免疾病优于生物制剂自第一个JAK抑制剂鲁索替尼于2011年获得FDA批准，现已有12种JAK抑制剂获得批准，为治疗风湿病、皮肤病、胃肠病和肿瘤疾病以及COVID-19提供了额外的可能性。第一代JAK抑制剂，特点是非选择性地靶向多个JAK；第二代JAK抑制剂，区别是对其中一个JAK的选择性增加。表1 已批准的第一代和第二代非变构JAK抑制剂的靶向JAK、适应症和剂量与生物制剂相比，使用JAK抑制剂治疗自免疾病通常显示出相似或优越的疗效。证据如下： 1.1 第一代JAK抑制剂托法替尼和巴瑞替尼 ①托法替尼是JAK抑制剂用于风湿病和胃肠病的先驱，于2012年首次被批准用于RA。 FDA批准托法替尼治疗RA的关键是ORAL III期临床试验，评估托法替尼对甲氨蝶呤或bDMARDs应答不佳的RA患者的治疗效果，5mg/次，每日两次，发现1）托法替尼比安慰剂治疗具有更大的临床和放射学益处，且2）与TNF抑制剂阿达木单抗相比，托法替尼具有非劣效性。 ②托法替尼的使用随后扩展到PsA、多关节型JIA和AS OCTAVE临床项目，涉及对常规治疗或TNF抑制剂应答不佳的溃疡性结肠炎患者，与安慰剂相比，托法替尼诱导和维持临床缓解和黏膜愈合，时间长达52周，具有显著治疗优势。 ③巴瑞替尼于2017年首次被EMA批准，2018年被FDA批准，用于治疗RA。 III期临床试验包括4项随机临床试验，涉及对甲氨蝶呤和bDMARDs应答不佳或对甲氨蝶呤无应答的RA患者。总体而言，巴瑞替尼达到了主要终点。数据显示1）所治疗的所有入组患者的临床结果（ACR20反应）优于安慰剂，2）在甲氨蝶呤应答不佳的患者中，疗效优于阿达木单抗；此外，巴瑞替尼治疗的RA患者影像学进展慢于用安慰剂治疗的患者。 ④巴瑞替尼（4 mg）于2023年4月被批准用于治疗2岁≥儿童的多关节JIA。 JUVE-BASIS试验表明，在各种形式的JIA（包括多关节型JIA、扩展型少关节型JIA、炎症相关关节炎JIA和青少年PsA）对标准治疗反应不足或不耐受的患者中，巴利替尼的有效时间明显长于安慰剂。 1.2 第二代JAK抑制剂乌帕替尼、非戈替尼和阿布西替尼 ①乌帕替尼于2019年8月首次被批准用于中度至重度活性RA，后续增加的适应症有PsA、AS、非放射学轴型脊椎关节炎、特应性皮炎、溃疡性结肠炎、克罗恩病。广泛的SELECT III期临床试验，纳入了对甲氨蝶呤或其他传统合成DMARDs或bDMARDs应答不佳的患者，证明了乌帕替尼（15mg）疗效优于安慰剂；作为单药治疗优于甲氨蝶呤和两种bDMARDs：1）在甲氨蝶呤应答不佳的患者中使用的阿达木单抗和2）在TNF抑制剂应答不佳的患者中使用的阿巴西普。 ②非戈替尼获得了EMA和PMD的批准，用于治疗RA（2020年）和溃疡性结肠炎（2021年）。 FINCH III期临床研究，涉及对TNF抑制剂或甲氨蝶呤应答不佳或对甲氨蝶呤治疗无效的RA患者，主要终点是患者在第12周或第24周获得ACR20反应的百分比。这些研究表明，非戈替尼相较于安慰剂疗效显著，并且与阿达木单抗相比，具有非劣效性。在SELECTION研究中，与安慰剂相比，在10周（诱导研究）和58周治疗（维持研究）中度至重度活动性溃疡性结肠炎患者后，非戈替尼（200 mg）使更大比例的患者得到临床缓解。 ③阿布西替尼于2021年9月被FDA批准用于治疗特应性皮炎。该批准是基于一个针对成人和青少年的大型III期临床项目。在中度至重度特应性皮炎中，阿布西替尼（100和200 mg）联合局部类固醇，或作为单药治疗，疗效均优于局部类固醇，有更多的患者达到了临床终点。此外，在患者接受了12周的开放标签治疗后，与安慰剂相比，阿布西替尼（100 mg和200 mg）降低了第40周时疾病加剧或恶化的风险。在JADE和COMPARE试验中，1）与安慰剂相比，阿布西替尼（100mg和200 mg）在12周和16周时减轻了中度至重度特应性皮炎的体征和症状。2）与杜匹单抗（目前是特应性皮炎治疗的金标准和最常用的处方药物）相比，阿布西替尼（200 mg）在第2周更好地控制了瘙痒。 02 JAK抑制剂选择性不足关联不良事件 JAK抑制剂影响细胞因子和生长因子下游信号通路，由于选择性不足还影响其他通道，因此一些不良反应是可预测的。图3 Janus激酶的功能和对应的抑制剂。 2.1 感染 JAK抑制剂的一个特殊副作用是重新激活水痘带状疱疹病毒感染。考虑到干扰素在抗病毒反应中的作用，这种副作用对所有JAK抑制剂都是共同的。然而，保留JAK2和JAK3活性可以带来更好的安全性。 2.2 血液学变化 ①常见淋巴细胞数量减少。 γ链细胞因子通过JAK1、JAK2和JAK3发出信号。这些细胞因子在适应性免疫细胞的发育、增殖和功能中发挥作用。因此，在JAK抑制剂治疗后，常见淋巴细胞数量的短暂性和可逆性减少。 ②血红蛋白水平可能会降低。 JAK2介导促红细胞生成素受体下游的信号通路，在使用第一代JAK抑制剂、或小剂量乌帕替尼、或JAK2抑制剂卓菲替尼治疗后，血红蛋白水平可能会降低，然而只有不到1%的RA患者在使用托法替尼时显示出有意义的变化。正如预期的那样，保留JAK2信号通路的JAK抑制剂（非戈替尼、阿布西替尼和利特昔替尼）与血红蛋白下降无关。 ③血小板水平降低。无论JAK的选择性如何，大多数JAK抑制剂的治疗都会导致血小板数量适度和短暂地降低。 2.3 脂质谱变化通常靶向JAK1的JAK抑制剂治疗的患者中，会发生胆固醇水平的升高。因为通过JAK1发出信号的细胞因子参与了胆固醇代谢。具体是JAK1影响干扰素和IL-6。1）I型干扰素能够减少胆固醇的生物合成。同样，2）IL-6能够通过降低肝脏脂质的合成、刺激脂质摄取和增加脂解来控制胆固醇水平。 2.4 心血管和血栓栓塞风险心血管和血栓栓塞风险与所有商业上售的JAK抑制剂（氘可来昔替尼除外）相关，其中男性患者、有心血管风险的个体（无论治疗方法如何）、65岁以上的患者和既往有心血管事件的患者发病率更高。这些不良事件不太可能用抑制单一的JAK来解释，但选择性更强的第二代JAK抑制剂似乎与MACE（主要心血管事件）、VTE（静脉血栓栓塞症）的增加无关。 2.5 肿瘤风险从机制的角度来看，目前尚不清楚JAK的选择性抑制是否与较低的肿瘤风险相关。使用鲁索利替尼治疗后，骨髓纤维化和多细胞血症患者的非黑色素瘤皮肤癌（NMSC）风险增加，这是可能的致癌效应的第一个信号。 03 从器官选择性角度开发JAK抑制剂是一种更安全的方式吗？为了减少不良反应并提升JAK抑制剂的疗效，一个关键的探索方向在于开发具有不同配方的JAK抑制剂，旨在实现对组织器官的选择性靶向。然而口服给药来实现器官选择性难以做到，除非是靶向胃肠道炎症。 3.1 最有效的策略：局部JAK抑制剂随着仿制药的涌现，JAK抑制剂的使用范围扩大，原则上可以代替类固醇。局部JAK抑制剂可治疗的疾病包括斑秃、白癜风和牛皮癣，以及慢性手部湿疹、苔藓样变和对毒藤暴露的过敏反应。皮肤病方面，重点关注JAK抑制剂的抗瘙痒作用。 ①鲁索替尼第一个被批准用于轻中度特应性皮炎的短期和非持续慢性治疗，后续适应症还有成人和青少年非节段性白癜风。两项III期临床试验显示，使用鲁索替尼（0.75%或1.5%乳膏）8周后，有更大比例的患者在研究者全球评估（IGA）评分中达到了0或1分（即与基线相比，症状改善超过了2%），还在12h内显著控制了瘙痒症状。来自小型研究和病例报告的初步数据表明，鲁索替尼（1%乳膏）有希望治疗成人和儿童斑秃。图4鲁索替尼乳膏鲁索替尼在局部应用后的生物利用度相对较低，预计没有口服给药相关的不良反应 ②迪高替尼仅在日本被批准用于特应性皮炎。在III期临床研究中，每日两次使用0.5%浓度的软膏对中度至重度特应性皮炎的成人患者疗效显著，且这些患者对该软膏的耐受性良好。图5迪高替尼软膏 3.2 透皮给药法由于注射类固醇经常用于治疗关节、滑囊和肌腱的疼痛，那么注射JAK抑制剂也可能同样有效。临床试验的结果显示，与TNF抑制剂相比，JAK抑制剂更有效地缓解了RA患者的疼痛症状。 ①透皮贴片或微针阵列治疗RA。在类风湿性关节炎大鼠模型中，采用透皮贴片或微针阵列释放托法替尼，4小时内药物释放率分别为24%和95%，渗透率12%和85%，检测到滑膜增生、软骨和骨侵蚀以及循环细胞因子水平显著下降。 3.3 吸入JAK抑制剂另一个热门领域是针对呼吸系统疾病的组织特异性JAK抑制剂的开发。大多数导致特应性皮炎的细胞因子也参与了2型哮喘和非2型哮喘的发病机制。其中一些细胞因子已经被单克隆抗体靶向，因此我们有理由使用可吸入JAK抑制剂治疗哮喘。一些化合物已经在临床前动物模型中进行了测试： ①可吸入化合物iJak-381治疗哮喘。iJak-381被设计能够抑制肺中的JAK1。在哮喘动物模型中，iJak-381抑制IL-13、JAK1和STAT6信号轴，并使嗜酸性粒细胞和中性粒细胞的肺内流量正常化。此外，iJak-381以剂量依赖的方式逆转肺部炎症。 ②LAS194046治疗气道炎症。LAS194046是JAK1和JAK3化合物。在卵清蛋白诱导的气道炎症模型中，LAS194046在过敏原激发前1h进行治疗，能够抑制嗜酸性粒细胞和中性粒细胞浸润，改善肺功能。 ③托法替尼气溶胶治疗粉尘感染和慢性鼻窦炎合并鼻息肉病。在粉尘感染小鼠中，托法替尼可降低支气管肺泡灌洗液中的嗜酸性粒细胞数量和蛋白质浓度。鼻内给药托法替尼对慢性鼻窦炎合并鼻息肉病的小鼠模型也有效，可显著减少嗜酸性粒细胞浸润和息肉样病变。 ④R507预防慢性闭塞性气道疾病。R507是JAK3和JAK1抑制剂。在同种异体气管移植模型中，口服和气溶胶R507均可消除炎症细胞浸润和纤维增生引起的气道管腔闭塞，修复受损的上皮表面；气溶胶给药后，血浆R507水平是全身治疗时的10%。 04 干扰JAK通路的其他方式？除了直接抑制JAK酶活性外，研究人员正在探索选择性干扰JAK通路的替代策略。这些替代方案包括开发化学修饰的小干扰RNA（siRNAs）来沉默JAK依赖途径，或开发代谢物（或代谢物衍生物），抑制促炎因子。 4.1 新型JAK抑制剂——siRNA 目前，siRNA治疗包括罕见和常见疾病，但没有靶向JAK-STAT信号通路。临床前研究表明，在白癜风、IBD和乳腺癌模型中，靶向JAK1和JAK2合成siRNA可有效抑制JAK家族成员的表达，抑制JAK介导的信号传导。 ①JAK1选择性先导siRNA si3033治疗白癜风。在小鼠白癜风模型中，单次皮下注射si3033可诱导长达5周的治疗效果。si3033在注射部位有局部残留，在肝、脾和肾等器官中也有积累，需要在适当的动物或细胞模型中进一步研究。 4.2 JAK抑制剂——衣康酸衣康酸是三羧酸循环的旁路代谢产物，具有抗炎作用。衣康酸及其衍生物抑制体外脂多糖刺激巨噬细胞产生促炎分子，抑制T细胞的糖酵解和氧化磷酸化。 ①衣康酸衍生物治疗脓毒症和银屑病。衣康酸二甲酯或4-辛基衣康酸酯已在脓毒症和银屑病的动物模型中显示出疗效。通过与小鼠JAK1蛋白的假激酶结构域的半胱氨酸共价相互作用，抑制其激酶活性。 ②衍生物4-甲基衣康酸（SCD-153）治疗斑秃。一项研究评估了这种衍生物在体内和体外治疗斑秃的应用，发现SCD-153比其他衣康酸衍生物具有更强的皮肤和细胞穿透性。小结风湿病学中一个重要的、未得到满足的需求来自于难治性或对生物药无应答的RA患者。JAK抑制剂已经在临床上使用了10多年，并为自身免疫性疾病和炎症性疾病的患者提供了一个重要的治疗选择。有明确的证据表明JAK抑制剂的疗效往往优于生物制剂，但JAK抑制剂对65岁以上、吸烟或有心血管疾病、血栓栓塞或癌症风险的患者带有一个黑盒警告。JAK抑制剂的不良反应已经引起了人们关注，使用JAK抑制剂时，了解不良事件的实际风险水平，已经是临床医生的一个重要考虑因素。目前的重点是获得对与疾病相关的JAK的更高选择性。JAK的特异性在临床中显然可以提供关键的优势，例如非戈替尼降低带状疱疹再活化的发生率，氘可来昔替尼拥有更好的安全性，利特希替尼治疗斑秃的良好疗效。我们可以设想，未来可以开发出针对所有JAK的特定抑制剂，再根据疾病或疾病的一个阶段及其相关的细胞因子谱，精确地定制治疗和联合治疗。参考文献：https://doi.org/10.1038/s41584-024-01153-1 声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床3期

2024-10-22

·PRNewswire

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期引进/卖出并购孤儿药

100 项与甲苯磺酸利特昔替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14924

研发状态

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适应症	国家/地区	公司	日期
斑秃	美国	Pfizer Inc.	2023-06-23

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适应症	最高研发状态	国家/地区	公司	日期
非节段型白癜风	临床3期	美国	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	中国	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	日本	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	澳大利亚	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	保加利亚	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	加拿大	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	德国	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	印度	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	意大利	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	墨西哥	Pfizer Inc.	2022-12-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03395184 (CTgov)	临床2期	克罗恩病	244	Placebo (Induction Period: Placebo QD)	壓鑰網醖獵夢築齋積鹹(淵網夢選艱廠衊鹽選鹽) = 憲願鏇構製鏇窪積廠憲觸積蓋繭鏇蓋選醖簾廠 (製餘願築製製艱構鬱憲, 衊構願襯觸網願鑰遞繭 ~ 觸範衊夢築鬱鹽獵顧鏇) 更多	-	2024-10-30
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	壓鑰網醖獵夢築齋積鹹(淵網夢選艱廠衊鹽選鹽) = 蓋醖選蓋構壓淵構醖壓觸積蓋繭鏇蓋選醖簾廠 (製餘願築製製艱構鬱憲, 鏇糧壓艱淵製膚壓構壓 ~ 鑰鹹夢範壓窪顧簾糧願) 更多
NCT03732807 (ALLEGRO, Pubmed \| Am J Clin Dermatol)	临床2/3期	斑秃	718	Ritlecitinib 50 mg	衊積範廠製鬱積繭齋膚(範鏇醖衊廠鏇獵膚憲鑰) = 鬱獵衊鹽鏇憲壓廠範簾選鬱鬱鏇膚壓襯膚積壓 (積醖壓範齋齋夢壓製製 )	积极	2024-10-23
				Ritlecitinib 30 mg	衊積範廠製鬱積繭齋膚(範鏇醖衊廠鏇獵膚憲鑰) = 齋簾夢鏇廠顧願獵鬱廠選鬱鬱鏇膚壓襯膚積壓 (積醖壓範齋齋夢壓製製 )
ALLEGRO phase 2b/3 and long-term phase 3 clinical studies (Pubmed \| Br J Dermatol)	临床2/3期	斑秃	-	Ritlecitinib 50 mg	鹽鏇簾廠遞獵網鹹膚選(獵網蓋鏇獵網構鹹蓋顧) = 襯範廠膚淵選衊觸窪鏇築窪襯襯築鹽鏇醖淵選 (廠窪糧顧夢選構淵憲衊, 46.8/43.2) 更多	积极	2024-10-21
				Ritlecitinib 200/50 mg	鹽鏇簾廠遞獵網鹹膚選(獵網蓋鏇獵網構鹹蓋顧) = 繭蓋蓋鹽齋鑰繭衊獵鏇築窪襯襯築鹽鏇醖淵選 (廠窪糧顧夢選構淵憲衊, 50.9/51.7) 更多
NCT05650333 (CTgov)	临床1期	斑秃	15	Ritlecitinib 20 mg	構襯齋積餘顧鹽窪鑰顧(餘廠繭製膚鑰簾餘壓憲) = 繭鹹憲餘願網製獵艱憲選艱築壓憲觸憲鏇繭鑰 (觸範鬱顧積製廠觸衊壓, 襯艱壓齋糧餘築顧選積 ~ 壓糧遞膚網選鑰鹽鹹壓) 更多	-	2024-10-08
NCT03732807 (ALLEGRO phase 2b/3, Pubmed \| Dermatol Ther (Heidelb))	临床2/3期	斑秃	522	Ritlecitinib 30 mg	觸觸衊醖範憲窪壓鑰蓋(顧蓋願膚積壓糧齋衊鹽): OR = 2.12 (95% CI, 1.23 ~ 3.65), P-Value = < 0.05	积极	2024-09-10
				Ritlecitinib 50 mg
NCT04006457 (ALLEGRO-LT, EADV2023)	临床3期	斑秃	447	Ritlecitinib 200 mg	壓繭製壓鏇艱積艱餘製(簾獵繭鹹顧齋構窪觸餘) = 選憲繭選簾築選繭構願壓獵夢遞壓觸淵網艱顧 (襯鏇糧觸醖壓築構鏇遞 ) 更多	-	2023-10-11
				Ritlecitinib 50 mg	壓繭製壓鏇艱積艱餘製(簾獵繭鹹顧齋構窪觸餘) = 膚願醖夢窪壓鬱選鏇壓壓獵夢遞壓觸淵網艱顧 (襯鏇糧觸醖壓築構鏇遞 ) 更多
NCT03732807 (ALLEGRO phase 2b/3, EADV2023)	临床2/3期	斑秃	191	Ritlecitinib 50mg QD	鬱繭範壓膚構醖襯獵憲(衊憲築淵膚鑰醖遞糧製) = 膚構廠簾鹹積壓衊膚鬱膚選襯廠簾積衊蓋淵願 (衊襯廠膚繭簾糧壓觸遞 ) 更多	-	2023-10-11
NCT05040295 (CTgov)	临床1期	-	12	Ritlecitinib (Treatment A: Ritlecitinib 30 mg Intact Adult Capsule)	衊鏇艱鬱鑰蓋製鑰糧願(糧築鏇鹽鑰蓋遞醖膚糧) = 壓醖網鏇網選鬱憲醖齋襯艱簾淵選衊夢膚鏇餘 (廠鹽鬱顧網襯遞鑰艱齋, 壓鏇鑰獵壓淵構糧製觸 ~ 齋顧鏇構簾鏇餘築範積) 更多	-	2023-08-21
				Ritlecitinib (Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules)	衊鏇艱鬱鑰蓋製鑰糧願(糧築鏇鹽鑰蓋遞醖膚糧) = 選構顧範鹽選鏇衊廠鬱襯艱簾淵選衊夢膚鏇餘 (廠鹽鬱顧網襯遞鑰艱齋, 壓鹽簾繭觸鹽襯壓餘簾 ~ 壓衊鹹構膚顧鏇艱願選) 更多
NCT03732807 (ALLEGRO, WCD2023) 人工标引	临床2/3期	斑秃	718	Ritlecitinib 50 mg	壓鏇衊網觸簾鹹製鹹廠(鹹廠糧構餘積鑰膚蓋鹹) = 窪廠積積選鬱艱廠網醖築壓鹹齋製製觸繭憲繭 (醖糧積製窪糧蓋網鏇顧 ) 更多	积极	2023-07-06
				Ritlecitinib 200 mg + 50 mg	壓鏇衊網觸簾鹹製鹹廠(鹹廠糧構餘積鑰膚蓋鹹) = 膚構鏇壓蓋衊繭餘鏇壓築壓鹹齋製製觸繭憲繭 (醖糧積製窪糧蓋網鏇顧 ) 更多
ALLEGRO-LT (WCD2023)	临床3期	斑秃	447	Ritlecitinib 200 mg	壓蓋願衊範製選顧網積(夢積網構廠糧網範窪觸) = 齋餘獵醖齋網蓋鑰夢簾鬱築鑰餘繭觸齋範製醖 (餘壓夢網鏇醖糧構願夢 ) 更多	积极	2023-07-06
				Ritlecitinib 50 mg	醖蓋憲範淵選獵鬱鏇鹹(淵鑰範築艱餘膚願淵糧) = 築遞齋遞觸簾鬱醖鑰願廠膚簾鑰願餘積積淵蓋 (鏇鹽鹹淵獵膚製繭廠憲 ) 更多