A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.

开始日期2025-12-14

申办/合作机构

Incyte Corp.

NCT06855498

/ Recruiting临床3期

A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

开始日期2025-02-28

申办/合作机构

Incyte Corp.

CTIS2024-511881-35-00

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis - INCB 54707-306

开始日期2025-02-10

申办/合作机构

Incyte Corp.

100 项与 Povorcitinib 相关的临床结果

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100 项与 Povorcitinib 相关的转化医学

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100 项与 Povorcitinib 相关的专利（医药）

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项与 Povorcitinib 相关的文献（医药）

2025-10-01·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib in patients with extensive vitiligo in a phase 2, randomized, double-blinded, dose-ranging, placebo-controlled study

Article

作者: Passeron, Thierry ; Pandya, Amit G ; Wagya, Kofi ; Erskine, Lois ; Santos, Leandro L ; van Geel, Nanja ; Brown, Kurt ; Ezzedine, Khaled ; Blauvelt, Andrew

BACKGROUND:

No repigmentation treatments are approved for vitiligo affecting > 10% body surface area.

OBJECTIVE:

To assess efficacy and safety of povorcitinib (oral, selective Janus kinase 1 inhibitor) in extensive nonsegmental vitiligo.

METHODS:

This double-blinded, placebo-controlled, dose-ranging phase 2 study (NCT04818346) randomized adult patients 1:1:1:1 to once-daily povorcitinib 15, 45, or 75 mg or placebo for 24 weeks. Subsequently, patients received povorcitinib 45 mg (initially randomized to 45 mg) or 75 mg (initially randomized to placebo, 15, or 75 mg) until week 52, followed by 24-week post-treatment follow-up. Primary endpoint was percentage change from baseline in total Vitiligo Area Scoring Index (T-VASI) at week 24.

RESULTS:

Of 171 patients (mean total body surface area/T-VASI, 28.2%/25.5) randomized, 82.5% completed the 24-week treatment. At week 24, povorcitinib significantly improved T-VASI from baseline (15 mg, 19.1%; 45 mg, 17.8%; 75 mg, 15.7%) versus placebo (-2.3%; least squares mean povorcitinib vs placebo, P < .01). Continuous improvement was observed through week 52. Incidence of grade ≥ 3 treatment-emergent adverse events was similar across treatment groups, with no new safety signals.

LIMITATIONS:

Limited demographic diversity.

CONCLUSION:

Povorcitinib demonstrated substantial total body and facial repigmentation in adult patients with extensive nonsegmental vitiligo and was generally well tolerated through 52 weeks of treatment.

2025-09-01·JAMA Dermatology

Efficacy and Safety of Medical Interventions for Moderate to Severe Hidradenitis Suppurativa

Review

作者: Midgette, Bria ; Cohn, Erica ; Strunk, Andrew ; Frasier, Kelly ; Garg, Amit

Importance:

There is limited comparative information on regulatory approved and pipeline treatments in hidradenitis suppurativa (HS).

Objective:

To compare efficacy, safety, and tolerability of treatments for moderate to severe HS.

Data Sources:

MEDLINE, Embase, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials were searched from inception to June 28, 2024.

Study Selection:

Phase 2 and 3 randomized clinical trials of medical interventions (cytokine inhibitors, small molecule inhibitors, cell inhibitors, and other novel immune or inflammatory modifiers) for adults with moderate to severe HS having primary efficacy assessments between 12 and 16 weeks.

Data Extraction and Synthesis:

Data extraction and risk of bias assessments were performed independently by 2 reviewers. Efficacy outcomes were analyzed using random-effects network meta-analysis. Safety and tolerability outcomes were analyzed using pairwise fixed-effect meta-analyses vs placebo. Data analysis was performed between August 22, 2024, and April 7, 2025.

Main Outcomes and Measures:

Primary efficacy, safety, and tolerability outcomes were Hidradenitis Suppurativa Clinical Response (HiSCR)-50, occurrence of serious adverse events (SAEs), and treatment discontinuation due to adverse events, respectively. HiSCR-75 was a secondary efficacy outcome.

Results:

Of 26 eligible trials, 25 had available HiSCR-50 data, including 5767 total patients and 39 unique treatments. Compared with placebo, the following treatments were associated with significantly higher HiSCR-50 response rates: sonelokimab, 120 mg, every 4 weeks; lutikizumab, 300 mg, every 2 weeks; adalimumab, 40 mg, once per week; sonelokimab, 240 mg, every 2 weeks; bimekizumab, 320 mg, every 2 weeks; povorcitinib, 15 mg, once per day; bimekizumab, 320 mg, every 4 weeks; secukinumab, 300 mg, every 4 weeks; and secukinumab, 300 mg, every 2 weeks. Most differences between adalimumab, 40 mg, once per week, and other targeted treatments were not statistically significant. The percentage of patients experiencing SAEs ranged from 0% to 10% in the placebo groups, 0% to 8% in the adalimumab (40 mg, once per week) groups, and 0% to 6% in the other active treatment groups. The percentage of patients discontinuing treatment due to adverse events ranged from 0% to 10% in the placebo groups, 0% to 4% in the adalimumab (40 mg, once per week) groups, and 0% to 15% (ropsacitinib) in the other active treatment groups.

Conclusions and Relevance:

This network meta-analysis provides evidence for the comparative efficacy and safety of currently approved and pipeline medications for moderate to severe HS in the absence of head-to-head trials.

2025-06-03·Expert Review of Clinical Immunology

Potential future biologic therapies for the treatment of vitiligo: focus on phase 2 and 3

Review

作者: Scalvenzi, Massimiliano ; Lizzi, Ludovica ; Coronella, Luigi ; Cimmino, Marianna ; Patruno, Cataldo ; Picone, Vincenzo ; Napolitano, Maddalena

INTRODUCTION:

Vitiligo is a chronic autoimmune skin disorder characterized by the loss of melanocytes, leading to depigmented patches on the skin and mucous membranes. Its increasing prevalence and impact on patients' quality of life highlight the need for updated therapeutic strategies.

AREAS COVERED:

This review discusses recent advances in the understanding of vitiligo pathogenesis, focusing on genetic predisposition, environmental triggers, and immune dysregulation-particularly the role of autoreactive CD8+ T cells and inflammatory cytokines such as IFN-γ. The literature search included recent clinical trials and emerging therapies. Novel approaches, including JAK inhibitors (e.g. povorcitinib, upadacitinib) and monoclonal antibodies (e.g. anifrolumab), are evaluated for their efficacy and safety based on phase II and III clinical trial data.

EXPERT OPINION:

Targeted therapies that address immune mechanisms and oxidative stress represent promising advances in vitiligo management and may substantially improve patient outcomes in the near future.

项与 Povorcitinib 相关的新闻（医药）

2025-09-22

·PRNewswire

Prurigo Nodularis market to exhibit growth at a CAGR of 23.2% (2020-2034), driven by strong uptake of DUPIXENT, recent approval of NEMLUVIO, promising JAK and OX40 inhibitors in the Pipeline, along with rising prevalence | DelveInsight

The prurigo nodularis treatment landscape has been evolving in recent years, with increasing attention from the pharmaceutical industry due to the chronic and debilitating nature of the condition. There is growing recognition of the need for effective treatments that can break the persistent itch-scratch cycle that exacerbates the disease. Additionally, the launch of emerging therapies such as Povorcitinib, OPZELURA, Rocatinlimab, Barzolvolimab, and others will further fuel the market growth. LAS VEGAS, Sept. 22, 2025 /PRNewswire/ -- DelveInsight's Prurigo Nodularis Market Insights report includes a comprehensive understanding of current treatment practices, prurigo nodularis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Prurigo Nodularis Market Report According to DelveInsight's analysis, the market size for prurigo nodularis was found to be nearly USD 1 billion in the leading markets in 2024, which is anticipated to grow tremendously owing to the uptake of approved therapies and the emerging pipeline moving towards patients inadequately controlled on topical therapies. In 2024, among all the current therapies for prurigo nodularis, the highest estimated revenue was generated by DUPIXENT, i.e., nearly USD 630 million in the United States. The total diagnosed prevalent cases of prurigo nodularis in the 7MM were ~614,000 in 2024, out of which the highest prevalent cases of this disease were in the United States, with major contribution by patients aged 65 years and old. The US, EU4, and the UK show a higher prevalence of prurigo nodularis in females, which could be attributed to hormonal or genetic factors influencing the development of the condition. Japan, on the other hand, has a significant male predominance, which may indicate regional genetic or lifestyle factors that predispose men to a higher risk of developing the condition. DUPIXENT (dupilumab) became the first FDA-approved treatment for prurigo nodularis in September 2022, with its EU approval expanded in December 2022 for adults with moderate-to-severe cases. Japan's MHLW also approved DUPIXENT in June 2023 for patients unresponsive to conventional treatments. Based on its existing performance and physician acceptance, we anticipate it to generate more than USD 1.2 billion by 2030 in the 7MM. In recent developments for prurigo nodularis treatment, NEMLUVIO (nemolizumab) received US FDA approval in August 2024 for adult patients, with approximately 1,100 healthcare professionals prescribing it since its launch. Prior to this, NEMLUVIO was approved in Japan as the brand name MITCHGA (nemolizumab) in March 2024 for prurigo nodularis in adults and children aged 13 and older, and was launched by Maruho in June 2024. In February 2025, Galderma received marketing authorization for NEMLUVIO from both the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) for the SC treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Leading companies developing emerging therapies for prurigo nodularis include Incyte, Amgen, Kyowa Kirin, and Celldex Therapeutics, which are advancing promising candidates that are expected to enter the prurigo nodularis market in the coming years. The promising prurigo nodularis therapies in the pipeline include Povorcitinib, OPZELURA (ruxolitinib), Rocatinlimab, Barzolvolimab (CDX-0159), and others. Discover which therapies are expected to grab the major prurigo nodularis treatment market share @ Prurigo Nodularis Market Report Key Factors Driving the Prurigo Nodularis Market Rising Prurigo Nodularis Disease Prevalence and Awareness The increasing prevalence of prurigo nodularis, particularly among individuals with underlying skin conditions like atopic dermatitis and eczema, has heightened the demand for effective treatments. The US accounted for approximately 261K diagnosed prevalent cases of prurigo nodularis in 2024. These cases are expected to increase during the forecast period (2025−2034) owing to growing populations, improved diagnostic methods, changes in lifestyle and environmental factors, and advancements in medical technology, allowing for better treatment. Moreover, there is a growing awareness among healthcare professionals and patients about the condition, leading to earlier diagnosis and intervention. Drug Approvals in Prurigo Nodularis Market The approval of DUPIXENT (dupilumab) in 2022 and NEMLUVIO (nemolizumab) in 2024 provides a significant breakthrough for patients with moderate-to-severe prurigo nodularis. These prurigo nodularis therapies offer targeted therapies with proven efficacy. As more treatments are developed and approved, expanding access to biologic therapies like DUPIXENT and NEMLUVIO through improved insurance coverage and cost reduction programs could make these therapies more accessible to a broader range of patients. Emerging Therapies in Prurigo Nodularis Market The emerging prurigo nodularis clinical trial landscape offers a diverse range of therapeutic alternatives, including rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), barzolvolimab (Celldex), and others across various treatment lines. The expected launch of these therapies shall further create a positive impact on the prurigo nodularis market. Prurigo Nodularis Market Analysis The treatment landscape for prurigo nodularis has seen significant advancements in recent years, driven by growing interest from the pharmaceutical sector due to the condition's chronic and distressing nature. Current therapies aim primarily to alleviate itching and inflammation. Potent topical corticosteroids are frequently used to calm inflamed skin and ease itching, while tacrolimus ointment offers a non-steroidal alternative with anti-inflammatory benefits. Moisturizers, or emollients, play a vital role in hydrating dry skin and enhancing the effectiveness of other treatments. Non-drowsy antihistamines like fexofenadine can also help control the itch. Phototherapy, including UVA or UVB light therapy, is effective in reducing nodules and itching. Psychological support may help patients cope with stress-related flare-ups. In more severe cases, systemic immunosuppressants such as oral corticosteroids, ciclosporin, methotrexate, or azathioprine are prescribed. A major milestone in treatment was the FDA approval of DUPIXENT, the first medication specifically authorized for prurigo nodularis. DUPIXENT, a monoclonal antibody that blocks IL-4 and IL-13 signaling, helps reduce inflammation and severe itching. Another breakthrough came in August 2024 with the FDA approval of NEMLUVIO, a monoclonal antibody targeting IL-31, offering a new therapeutic option for managing this condition. To know more about prurigo nodularis treatment guidelines, visit @ Prurigo Nodularis Treatment Options Prurigo Nodularis Competitive Landscape Although there are very few approved medications for prurigo nodularis, several drugs are currently under research and development. These include rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), and barzolvolimab (Celldex), which are being investigated as potential treatments for prurigo nodularis. Povorcitinib is an oral JAK1 inhibitor currently in Phase III clinical trials for prurigo nodularis, with data expected by 2026 and a launch anticipated between 2027–2028. In March 2024, Incyte presented positive late-breaking Phase II data showing that povorcitinib met its primary and secondary endpoints in treating prurigo nodularis. Ruxolitinib, a topical JAK1/2 inhibitor, is also being investigated for prurigo nodularis, with Phase III trial data was presented in March 2025, and a launch is anticipated between 2026–2027. Currently, no oral or topical therapies are approved for prurigo nodularis. While the first study, TRuE-PN1, met its primary endpoint and all key secondary endpoints, the second trial, TRuE-PN2, did not reach statistical significance on its primary endpoint despite the numbers favoring OPZELURA. Rocatinlimab (formerly AMG 451 / KHK4083) is a monoclonal antibody that targets the OX40 receptor to inhibit and reduce pathogenic T-cells, with potential for treating prurigo nodularis. The company launched a Phase III trial for rocatinlimab in July 2024 to assess its efficacy in treating prurigo nodularis. The anticipated launch of these emerging therapies is poised to transform the prurigo nodularis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the prurigo nodularis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about prurigo nodularis marketed and pipeline drugs @ Prurigo Nodularis Clinical Trials Recent Developments in the Prurigo Nodularis Market In July 2025, Incyte's Q2 2025 report noted that the launch of povorcitinib for the treatment of prurigo nodularis is expected by 2027–2028. In March 2025, Incyte announced the results of Phase III clinical trials (TRuE-PN1 and TRuE-PN2 studies) evaluating ruxolitinib cream 1.5% (OPZELURA) in patients with prurigo nodularis at the 2025 American Academy of Dermatology (AAD) Annual Meeting. According to the Q2 2025 Kyowa Kirin corporate presentation, Phase III completion for rocatinlimab in prurigo nodularis is expected by 2027. What is Prurigo Nodularis? Prurigo nodularis is a long-term skin condition marked by the presence of numerous firm, itchy bumps or nodules that often result from persistent scratching or rubbing. These nodules can vary in size and commonly appear on the arms, legs, back, and chest. The main symptom is severe itching, which leads to repeated scratching, worsening the skin lesions, and causing them to become thickened, scaly, or darkened. In more advanced cases, the nodules may break open or become infected due to continuous irritation and trauma. While the precise cause of prurigo nodularis is not fully understood, it is frequently linked to underlying health issues such as atopic dermatitis, chronic kidney or liver disease, and psychological conditions like anxiety or depression. Diagnosis is mainly clinical, based on the distinct appearance of itchy, raised nodules. Healthcare professionals typically review the patient's medical history, particularly any related conditions, and perform a physical examination to assess the size, number, and distribution of the nodules, which are usually found on the limbs and trunk. Prurigo Nodularis Epidemiology Segmentation The prurigo nodularis epidemiology section provides insights into the historical and current prurigo nodularis patient pool and forecasted trends for the leading markets. The total diagnosed prevalent cases of prurigo nodularis in the US were around 261,900 cases in 2024. According to DelveInsight estimates, in 2024, among the age-specific diagnosed prevalent cases of prurigo nodularis in the US, the highest number of cases were found in the =65 years age group, followed by the 25–44 years age group, while the lowest number of cases was observed in the <15 years age group. The prurigo nodularis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Diagnosed Prurigo Nodularis Prevalence Gender-specific Diagnosed Prurigo Nodularis Prevalence Age-specific Diagnosed Prurigo Nodularis Prevalence Severity-specific Diagnosed Prurigo Nodularis Prevalence Scope of the Prurigo Nodularis Market Report Therapeutic Assessment: Prurigo Nodularis current marketed and emerging therapies Prurigo Nodularis Market Dynamics: Key Market Forecast Assumptions of Emerging Prurigo Nodularis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Prurigo Nodularis Market Access and Reimbursement Download the report to understand which factors are driving prurigo nodularis market trends @ Prurigo Nodularis Drug Treatment Table of Contents Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, among others. Prurigo Nodularis Clinical Trial Analysis Prurigo Nodularis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key prurigo nodularis companies, including Menlo Therapeutics, Galderma R&D, Kiniksa Pharmaceuticals, Sanofi, Maruho, among others. Epidermolysis Bullosa Market Epidermolysis Bullosa Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key epidermolysis bullosa companies, including Abeona Therapeutics, Castle Creek Biosciences, RHEACELL, Ishin Pharma, Holostem Terapie Avanzate, BridgeBio (Phoenix Tissue Repair), InMed Pharmaceuticals, Shionogi, Anterogen, among others. Bullous Pemphigoid Market Bullous Pemphigoid Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bullous pemphigoid companies, including AstraZeneca, Kyowa Kirin, Regeneron, Sanofi, Argenx, Innate Pharma, ARTham Therapeutics, Kaken Pharmaceutical, 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3期上市批准临床结果

2025-09-17

·Business Wire

Incyte Announces New 24-Week Phase 3 Data from the STOP-HS Clinical Trial Program of Povorcitinib in Hidradenitis Suppurativa at EADV 2025

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced new 24-week interim data evaluating the safety and efficacy of povorcitinib (INCB54707), an oral small-molecule highly-selective JAK1 inhibitor, from the pivotal Phase 3 STOP-HS clinical trial program in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS). These data will support the planned regulatory submissions for povorcitinib in HS in Europe and the United States in 2025 and early 2026, respectively. Across both STOP-HS1 and STOP-HS2, povorcitinib treatment resulted in continued clinically meaningful and statistically significant improvements for patients with active moderate to severe hidradenitis suppurativa (HS) through Week 24. The presentation will take place today at 2:45 p.m. CEST during a late-breaking oral presentation (Session: Late Breaking News; Presentation ID D1T01.1C) at the European Association of Dermatology and Venereology (EADV) 2025 Congress. “HS remains a challenging and often debilitating condition and many patients are in need of new, well-tolerated and effective therapies that address prominent signs and symptoms of the disease, including inflammatory lesions and pain,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We are pleased to share these late-breaking data with the dermatology community, including health care providers and people with HS. The STOP-HS abstract will provide additional detail on povorcitinib as an oral treatment option for HS and its ability to rapidly improve symptoms, with continued clinical responses seen through 24 weeks.” As previously reported, both STOP-HS1 and STOP-HS2 studies met their primary endpoint at each tested dose (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) at Week 12, with no increase from baseline in abscess or draining tunnel count. In addition, at Week 12, more patients treated with povorcitinib compared to placebo, achieved HiSCR75 (a ≥75% reduction from baseline in the total AN count at Week 12), ≥3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score, and Skin Pain NRS30; additionally, fewer patients experienced a flare by Week 12. New data at Week 24 show nearly 60% of efficacy-evaluable patients among the povorcitinib 45 mg and 75 mg treatment groups achieved HiSCR50. The percentage of povorcitinib treated patients achieving HiSCR50 compared to placebo at Week 12 and 24 was: STOP-HS1: 12-week 45 mg: 40.2% vs. 29.7% [P=0.024] 24-week 45 mg: 52.9%-64.0% 12-week 75 mg: 40.6% vs. 29.7% [P=0.0214] 24-week 75 mg: 50.0%-62.7% STOP-HS2: 12-week 45 mg: 42.3% vs. 28.6% [P=0.0035] 24-week 45 mg: 57.1%-58.0% 12-week 75 mg: 42.3% vs. 28.6% [P=0.0033] 24-week 75 mg: 56.3%-58.5% Additionally, across STOP-HS1 and STOP-HS2, povorcitinib treatment in both dosing groups resulted in continued improvements at Week 24 in endpoints associated with higher thresholds of response: HiSCR75 was achieved by 31.0%-40.3%, HiSCR90 by 13.8%-27.7% and HiSCR100 by 9.2%-21.3% of patients treated with povorcitinib. Those treated with povorcitinib also achieved greater improvements in skin pain, reducing pain by the first visit (Week 3) through Week 24. Further, 62%-70% of povorcitinib-randomized patients achieved skin pain scores of mild or no pain at Week 24. In both studies, participants receiving povorcitinib 45 mg and 75 mg achieved dt100 (a 100% decrease in draining tunnels from baseline, among those with ≥1 draining tunnel at baseline): 34.6% and 41.6% at Week 12 and 39.0% and 50.6% at Week 24, respectively. The overall safety profile of povorcitinib is consistent with previous data and both doses were well tolerated. Treatment-emergent adverse events (TEAEs) for patients who transitioned from placebo to povorcitinib (at Week 12) were 42.4%-54.3%, and 70.2%-78.7% for patients initially randomized to povorcitinib through Week 24. Serious adverse events, and adverse events of special interest (AESI) were observed in 2.9%-4.8% and 0%-1.4% of patients. No MACE or deaths occurred during this period. “HS is a complex and often misunderstood condition that can profoundly affect patients’ daily lives,” said Dr. Martina Porter, STOP-HS study investigator, Assistant Professor of Dermatology at Harvard Medical School and Vice Chair for Research and Academics, Department of Dermatology at Beth Israel Deaconess Medical Center. “Data from the STOP-HS clinical trial program highlight the potential of povorcitinib to address key signs and symptoms for those living with HS, and it is encouraging to see advancements in potential new, effective treatment options for this patient community.” More information regarding the 2025 EADV Congress can be found at: https://eadv.org/congress/scientific-programme/. About 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. 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. 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 >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. For more information on the STOP-HS studies, please visit: https://clinicaltrials.gov/study/NCT05620823 and https://clinicaltrials.gov/study/NCT05620836. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules and abscesses that can lead to irreversible tissue destruction and scarring.1,2 Over-activity of the JAK/STAT signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of HS.3 More than 150,000 patients in the U.S. are estimated to have moderate to severe HS.3 Given the debilitating nature of the condition, it can have a profoundly negative effect on patients’ quality of life.4 About 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). About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential offered by povorcitinib, planned regulatory submissions for povorcitinib and whether or when povorcitinib will be approved or commercially available for use in patients contain predictions, estimates and other forward-looking statements. 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, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-K for the quarter ended June 30, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements. ____________________ 1 McCarthy, S. (2025) Hidradenitis suppurativa. Annu Rev Med. 76(1):69-80. Link to source (https://pubmed.ncbi.nlm.nih.gov/39869430/) 2 Kirby J.S., et al. (2024) Efficacy and safety of the oral Janus kinase 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa in a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study. J Am Acad Dermatol. 90(3):521-529. Link to source (https://pubmed.ncbi.nlm.nih.gov/37871805/) 3 Maronese C.A., et al. (2024) Biologics for Hidradenitis suppurativa: evolution of the treatment paradigm. Expert Rev Clin Immunol. 20(5), 525-545. Link to source (https://pubmed.ncbi.nlm.nih.gov/38130204/) 4 McMillan K. (2014) Hidradenitis suppurativa: number of diagnosed patients, demographic characteristics, and treatment patterns in the United States. Am J Epidemiol. 179(12):1477-83. Link to source (https://pubmed.ncbi.nlm.nih.gov/24812161/)

临床结果临床2期临床3期

2025-09-03

·FiercePharma

Incyte bares 'whole truth' of living with hidradenitis suppurativa in new HCP campaign

“Everything that I do, everything that I think about, every decision that I make, it’s all based around HS,” one hidradenitis suppurativa patient says in a campaign video. A new awareness-raising effort from Incyte is aimed at giving doctors an up-close look at the emotional and physical challenges their patients with hidradenitis suppurativa (HS) face.HS is a chronic inflammatory skin condition that causes painful nodules and abscesses near hair follicles, most often in areas where skin rubs together, like the underarms, groin, buttocks and breasts.In addition to laying bare the physical symptoms of HS—quite literally, with a photo shoot capturing four people with HS wearing only their underwear—Incyte’s newly launched “HS Truths” campaign seeks to prove that the disease is more than skin-deep by delving into the emotional burdens of the disease.A campaign video features the four individuals sharing their experiences with HS, as text on-screen notes that HS is “more than a skin condition—it’s a daily struggle” and that more than 70% of HS patients report the condition has at least a moderate impact on their lives every week.“Everything that I do, everything that I think about, every decision that I make, it’s all based around HS,” one woman, Katelyn, says, as she and her peers go on to describe the many everyday instances that can be made extremely uncomfortable by their HS: sitting on long flights, wearing certain clothes, going to the restroom and even picking up their children.“It’s kind of like a different lifestyle of living, due to being so uncomfortable,” another of the patients, Jasmine, adds. The video ends with a call to action for U.S. healthcare providers, the campaign’s target audience: “Let’s get real about HS,” on-screen text reads. “Ready to raise expectations in HS care?” The “HS Truths” website features additional testimonials from the campaign’s four stars, including how the condition led them to lose work and struggle with mental health. It also offers statistics showing that, for example, a majority of HS patients experience negative emotions when talking to their doctors and that many are unaware of available treatment options and unhappy with their current ones.The site includes information about the emotional impacts of HS and the mechanisms of current treatments as well as a downloadable conversation guide to shape discussions with patients.“HS TRUTHS recognizes that each person’s experience is unique and emphasizes the importance of healthcare professionals engaging deeply with their HS patients,” Parish, another of the featured patients, said in the campaign’s launch announcement. “Too often, campaigns miss the reality—we’re not just talking about bumps under the arms. We’re talking about chronic pain, lost relationships and years of feeling dismissed. This campaign tells the whole truth.”Though the campaign is unbranded, the site includes a form that doctors can fill out to stay up to date on Incyte’s work in HS.Incyte is currently studying two JAK inhibitor candidates in HS: povorcitinib and ruxolitinib. The latter drug, boasting FDA approvals in atopic dermatitis and vitiligo, is marketed as Opzelura.HS approvals would pit Incyte’s treatments against AbbVie’s Humira, Novartis’ Cosentyx and UCB’s Bimzelx in the indication.

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100 项与 Povorcitinib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
结节性痒疹	临床3期	美国	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	日本	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	阿根廷	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	澳大利亚	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	奥地利	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	比利时	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	保加利亚	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	加拿大	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	智利	Incyte Corp.	2024-10-10
结节性痒疹	临床3期	捷克	Incyte Corp.	2024-10-10

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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


NCT05620836 \| NCT05620823 (STOP-HS2, Company_Website) 人工标引	临床3期	化脓性汗腺炎	-	Povorcitinib 45 mg (STOP-HS1)	構構膚廠壓衊廠範憲襯(獵簾淵顧壓壓範衊鏇鏇) = 鹽窪觸鹽繭壓顧築選積遞憲蓋醖鏇廠醖壓繭築 (蓋鬱鏇壓蓋糧繭憲選觸 ) 达到更多	积极	2025-03-17
				Povorcitinib 75 mg (STOP-HS1)	構構膚廠壓衊廠範憲襯(獵簾淵顧壓壓範衊鏇鏇) = 鑰範醖遞淵淵鏇願齋獵遞憲蓋醖鏇廠醖壓繭築 (蓋鬱鏇壓蓋糧繭憲選觸 ) 达到更多
NCT04818346 (AAD2024) 人工标引	临床2期	白癜风	171	Povorcitinib (age≤40 years)	憲鑰選廠壓鹽構憲觸衊(選膚淵築繭鏇顧網窪繭) = 衊糧鹽餘壓簾範簾艱夢壓衊憲餘鑰遞鏇窪鬱簾 (膚簾壓顧艱廠觸夢網蓋 )	积极	2024-03-10
				Povorcitinib (age>40 years)	憲鑰選廠壓鹽構憲觸衊(選膚淵築繭鏇顧網窪繭) = 壓糧醖醖衊鹽簾鬱獵衊壓衊憲餘鑰遞鏇窪鬱簾 (膚簾壓顧艱廠觸夢網蓋 )
NCT05061693 (Corporate Publications) 人工标引	临床2期	结节性痒疹	146	Povorcitinib 15 mg	齋廠糧淵鏇構構齋壓餘(製齋網繭積網選艱鑰窪) = 顧鹹夢積選構鬱構鹽鏇積艱選鹽範餘構衊遞鹹 (夢餘鑰夢夢選簾齋積衊 ) 达到更多	积极	2024-03-10
				Povorcitinib 45 mg	齋廠糧淵鏇構構齋壓餘(製齋網繭積網選艱鑰窪) = 廠鬱醖繭構獵醖鹹鑰齋積艱選鹽範餘構衊遞鹹 (夢餘鑰夢夢選簾齋積衊 ) 达到更多
NCT04818346 (Corporate Publications) 人工标引	临床2期	非节段型白癜风	171	povorcitinibpovorcitinib 15-to-75 mg	廠鹽繭鏇遞網獵積選鏇(繭衊鏇衊醖築選夢鏇鹽) = 選衊觸醖願鏇範築獵蓋蓋衊製憲餘廠積鏇繭襯 (構餘鏇繭齋構壓鑰廠窪 ) 更多	积极	2023-10-11
				povorcitinibpovorcitinib 45 mg	廠鹽繭鏇遞網獵積選鏇(繭衊鏇衊醖築選夢鏇鹽) = 積範齋構衊鹽鹽憲鬱鹽蓋衊製憲餘廠積鏇繭襯 (構餘鏇繭齋構壓鑰廠窪 ) 更多
EADV2023	临床2期	-	209	Povorcitinib 15 mg	憲構鬱窪顧顧繭簾選艱(齋蓋醖願齋齋壓鏇簾夢) = 鬱餘衊構衊選繭廠簾鬱獵製鹽製網構齋蓋艱衊 (鏇鏇觸醖鑰網鑰衊顧廠 )	-	2023-10-11
				Povorcitinib 45 mg	憲構鬱窪顧顧繭簾選艱(齋蓋醖願齋齋壓鏇簾夢) = 廠觸淵廠鏇廠鹽願範鬱獵製鹽製網構齋蓋艱衊 (鏇鏇觸醖鑰網鑰衊顧廠 )
NCT04818346 (phase 2b, EADV2023)	临床2期	白癜风 Fitzpatrick skin types I - III	171	Povorcitinib 15 mg	齋築廠積構齋構鬱齋艱(積廠範繭鹹鏇選積襯蓋) = 淵憲製襯網壓鹹鏇襯選鏇憲憲淵遞獵鹹壓積壓 (糧積繭願餘顧製鬱鬱壓 )	积极	2023-10-11
				Povorcitinib 45 mg	齋築廠積構齋構鬱齋艱(積廠範繭鹹鏇選積襯蓋) = 獵艱繭網範蓋艱壓積淵鏇憲憲淵遞獵鹹壓積壓 (糧積繭願餘顧製鬱鬱壓 )
NCT04476043 (phase 2 study, EHSF2023)	临床2期	化脓性汗腺炎	174	Povorcitinib 15 mg	簾簾艱網窪構製範膚窪(鑰積築鑰夢鹽網蓋壓範) = 11.5% 襯觸鹽觸衊窪窪構鏇積 (鬱願膚築鏇艱願鹹憲願 ) 更多	积极	2023-09-27
				Povorcitinib 45 mg
NCT04818346 (phase 2b, CTgov)	临床2期	非节段型白癜风	171	placebo+povorcitinib (Placebo)	夢醖積範鬱鏇淵顧夢製(廠鹹鏇醖夢廠積壓簾鑰) = 齋簾鏇壓艱範構鏇衊築鏇蓋醖夢夢鹹廠遞餘壓 (餘廠醖顧夢積衊衊構獵, 4.81) 更多	-	2023-07-05
				Povorcitinib (Povorcitinib 15 mg)	夢醖積範鬱鏇淵顧夢製(廠鹹鏇醖夢廠積壓簾鑰) = 築鏇襯鬱艱壓糧襯鏇範鏇蓋醖夢夢鹹廠遞餘壓 (餘廠醖顧夢積衊衊構獵, 4.56) 更多
NCT04476043 (phase 2 dose-ranging study \| phase 2 study, CTgov)	临床2期	化脓性汗腺炎	209	INCB054707 (INCB054707 15 mg)	選願願衊膚簾壓壓鏇鑰(襯網選醖顧淵顧構鏇簾) = 築製構願積蓋顧醖製鏇淵艱鹹築選廠築襯遞網 (顧選繭襯築齋積鑰鑰夢, 0.86) 更多	-	2023-01-26
				INCB054707 (INCB054707 45 mg)	選願願衊膚簾壓壓鏇鑰(襯網選醖顧淵顧構鏇簾) = 觸獵鏇鏇網艱觸夢遞積淵艱鹹築選廠築襯遞網 (顧選繭襯築齋積鑰鑰夢, 0.88) 更多
NCT04476043 (phase 2 dose-ranging study, EADV2022)	临床2期	化脓性汗腺炎	209	INCB054707 15 mg	構壓選鑰憲觸艱獵壓壓(鏇繭蓋獵選網製獵網艱) = 齋鑰憲鏇襯餘獵鹹憲醖鑰製觸餘範構構築襯鏇 (艱艱壓淵膚衊餘網網鏇 ) 更多	积极	2022-09-07
				INCB054707 45 mg	構壓選鑰憲觸艱獵壓壓(鏇繭蓋獵選網製獵網艱) = 鑰簾築顧餘鹽鹹獵簾廠鑰製觸餘範構構築襯鏇 (艱艱壓淵膚衊餘網網鏇 ) 更多