Prospective Observational Study to Evaluate Secukinumab Treatment Effectiveness in Pediatric Patients With Active Juvenile Enthesitis-related or Psoriatic Arthritis (Toddler)

This is a multicenter, non-interventional, cohort study in pediatric patients with active juvenile enthesitis-related or psoriatic arthritis

Start Date30 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06751238

/ Not yet recruitingPhase 1

An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis

The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

Start Date15 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06786936

/ Not yet recruitingNot ApplicableIIT

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

The investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
Glutamate concentration in the NAcc will be positively correlated with the magnitude of the inflammatory response and will be attenuated by IL-17A inhibition. Ultimately, this will be associated with an improvement in depressive symptoms.
The strength of coupling between early and late systems will be attenuated in the context of IL-17A-driven inflammation and will be correlated with less frequent switching behaviour following negative outcomes and ultimately depressive symptoms. This coupling will be re-established following IL-17 antagonism.
Patients whose depressive symptoms benefit most from IL-17A antagonism will exhibit greatest resting-state and task-specific functional connectivity between Th-NAcc.

Start Date28 Feb 2025

Sponsor / Collaborator

NHS Greater Glasgow & Clyde

[+2]

100 Clinical Results associated with Secukinumab

100 Translational Medicine associated with Secukinumab

100 Patents (Medical) associated with Secukinumab

2,239

Literatures (Medical) associated with Secukinumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Global research trends in biological therapy for ankylosing spondylitis: A comprehensive visualization and bibliometric study (2004–2023)

Article

Author: Wu, Zixiang ; Yang, Haicheng ; Huang, JinFeng ; He, Weiliang ; Yang, Xuanzhe

Ankylosing spondylitis (AS) is a chronic inflammatory disease primarily affecting the spine and pelvic bones. Recently, many researchers have confirmed that biological therapy is effective for AS patients, which provides a new perspective for the treatment of AS. This study aimed to evaluate the characteristics of scientific research on AS and biological therapy worldwide and investigate research hotspots and the direction of future trends. Global literature on AS and biological therapy published from 2004 to 2023 was searched in the Web of Science, Scopus, and PubMed databases. Visualization and bibliometric analysis were carried out using the VOSviewer and CiteSpace software with the retrieved data regarding countries, institutions, journals, authors, and keywords. A total of 2,243 related articles were included, showing that the number of articles in this field has increased annually. The highest number of articles were from the USA (24.39%), followed by Italy (14.36%), England (12.19%), Germany (10.66%), and Spain (7.86%). Braun J was the most prolific author, with a h-index of 16. The institution with the most articles was Charite Universitatsmedizin Berlin, and the Rheumatology journal had the highest number of publications. "janus kinase inhibitor" and "secukinumab" displayed a notable citation burst in recent years, indicating IL-17i and JAKi are research hotspots. More and more attention has been paid to the association between AS and biological therapy in the past two decades. The USA plays a leading role, and China has made remarkable progress. This study has provided a valuable reference for future research in this field.

01 Dec 2025·Immunologic Research

Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study

Article

Author: Merzel Šabović, Eva Klara ; Janić, Miodrag ; Kraner Šumenjak, Tadeja ; Božič Mijovski, Mojca

AbstractPsoriasis is a chronic, immune-mediated disease. The systemic inflammation triggered by psoriasis contributes significantly to increased cardiovascular risk. While various treatments completely clear the skin, the associated effects on systemic inflammation are not yet clear. We investigated residual systemic inflammation in successfully treated patients. Circulating disease-specific and non-specific inflammatory markers were measured and compared in 80 psoriasis patients (aged 30–45 years) successfully treated with topical therapy, methotrexate, adalimumab, secukinumab or guselkumab, and in 20 healthy controls. Non-specific inflammatory markers (high-sensitivity C-reactive protein (hs-CRP), complete blood count (CBC) parameters, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), mean platelet volume-to-platelet ratio (MPR), and red blood cell distribution width-to-platelet ratio (RPR)) and disease-specific inflammatory markers (interferon-γ (IFN-γ), tumor necrosis factor (TNF), interleukin (IL)-1β, IL-12p70, IL-17, and IL-23) were measured and compared between groups. Disease-specific cytokines (IFN-γ, TNF, IL-1β, IL-12p70, and IL-17, but not IL-23), were significantly elevated in patients compared to controls, while non-specific inflammatory markers showed no differences compared to controls. The residual disease-specific cytokines were similarly elevated in all five treated groups. In addition, they correlated significantly with body mass index (BMI) and waist circumference. Our results suggest that psoriasis patients have elevated residual disease-specific cytokines despite successful treatment, while the non-specific inflammatory markers are similar to those in control subjects. Residual disease-specific inflammatory markers correlated with BMI and waist circumference. A possible beneficial effect of body weight control in psoriasis patients merits further investigation. The study was registered at http://clinicaltrials.gov (identifier: NCT05957120) on July 24, 2023.

01 May 2025·Joint Bone Spine

Four-year secukinumab treatment outcomes in European real-world patients with axial spondyloarthritis and psoriatic arthritis

Article

Author: Ørnbjerg, Lykke Midtbøll ; Hetland, Merete Lund ; Macfarlane, Gary J ; Vorobjov, Sigrid ; Ahmadzay, Zohra Faizy ; Sánchez-Alonso, Fernando ; Hokkanen, Anna-Mari ; Christensen, Sara Nysom ; Bernardes, Miguel ; Jones, Gareth T ; Wallman, Johan K ; Onen, Fatos ; Codreanu, Catalin ; Gudbjornsson, Bjorn ; Laas, Karin ; Palsson, Olafur ; Michelsen, Brigitte ; Pirkmajer, Katja Perdan ; Østergaard, Mikkel ; Závada, Jakub ; Pons, Marion ; Georgiadis, Stylianos ; Castrejón, Isabel ; Rotar, Ziga ; Pavelka, Karel ; Mielnik, Pawel ; Loft, Anne Gitte ; Nordström, Dan ; Glintborg, Bente ; Ciurea, Adrian ; Heberg, Jette ; Rasmussen, Simon ; Iannone, Florenzo ; Nissen, Michael J ; Khmelinskii, Nikita ; van der Horst-Bruinsma, Irene

OBJECTIVESIn axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patients initiating secukinumab, we aimed to assess retention rates and proportions of patients achieving remission and low disease activity (LDA), according to disease activity measures and patient-reported outcomes at 24 and 48 months.PATIENTS AND METHODSData on patients with axSpA and PsA who initiated secukinumab treatment were pooled from 13 European registries. Analyses were performed overall and stratified according to the number of previous biologic/targeted synthetic Disease-Modifying Antirheumatic Drugs (b/tsDMARDs, 0/1/≥2). Kaplan-Meier plots and Cox regression analyses were performed to assess and compare secukinumab retention rates. Comparisons of remission and LDA rates were performed by logistic regression analyses.RESULTSThe overall 24-/48-month secukinumab retention rates were 61%/51% in 767 axSpA patients, and 64%/49% in 975 PsA patients, respectively. Compared to b/tsDMARD naïve patients, a higher risk of withdrawal from secukinumab was found for those with≥2 prior b/tsDMARDs in axSpA and PsA, and 1 prior b/tsDMARD in axSpA. Generally, remission and LDA rates were numerically higher in b/tsDMARD naïve patients. After adjustment for confounders, statistically significantly higher remission and LDA rates were found for b/tsDMARD naïve patients compared to patients with≥ 2 prior b/tsDMARDs at 24 months in axSpA and PsA.CONCLUSIONThis large European real-world study demonstrates that 4-year secukinumab retention rates were approximately 50% in both axSpA and PsA. b/tsDMARD naïve patients had higher retention, remission and LDA rates than patients with prior b/tsDMARD exposure.

184

News (Medical) associated with Secukinumab

17 Mar 2025

·www.fiercebiotech.com

Incyte posts phase 3 skin condition wins but details disappoint, sinking stock

While Incyte called the data positive, investors were unconvinced and sent the biotech’s share price down.\n Incyte has delivered a pair of pivotal wins for an oral JAK inhibitor in an inflammatory skin condition. But with the placebo-adjusted response rate down on phase 2, the results drew unfavorable comparisons to rival data and triggered a 15% drop in the biotech’s share price. The JAK1 inhibitor, povorcitinib, could offer an oral alternative to biologics in multiple indications and, if approved, partly offset the loss of exclusivity of Incyte\'s JAKi Jakafi later this decade. Incyte took the candidate into phase 3 trials in the skin condition hidradenitis suppurativa (HS) after seeing (PDF) placebo-adjusted response rates of up to 27.7% in a mid-stage study. Asked by analysts at recent investor events, Incyte executives declined to name the number they were targeting in the phase 3 trials but did say they expected to see a profile that is consistent with the earlier trial. The primary endpoints looked at the number of patients who had a 50% or greater reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count. In the first study, around 40% of patients on both the low and high dose met the criteria, versus around 30% on placebo. The drug and placebo figures in the second trial were around 42% and 29%, respectively. Adjusted for placebo, the response rates at the low and high dose were 10.5% and 10.9%, respectively, in the first trial. The figure for both doses was 13.7% in the second trial. In the earlier phase 2 trial, Incyte reported placebo-adjusted results of 17.3% and 27.7%, respectively, at the low and high doses used in the pivotal studies. Incyte saw higher placebo-adjusted results in a predefined subgroup of phase 3 patients who previously took a biologic. The biotech also found more people on povorcitinib had a 75% or greater improvement, experienced a reduction in flares and reported a more than three-point improvement on a pain scale. The overall safety profile of povorcitinib was consistent with previous data, according to Incyte.While the biopharma called the data positive, investors were unconvinced and sent the biotech’s share price down around 15% to just $58 in early premarket trading. The drop may reflect unfavorable comparisons between the phase 3 data and both Incyte’s midphase results and the evidence on rival biologics. UCB won approval for Bimzelx in HS after linking the biologic to placebo-adjusted response rates of 19% and 20% after 16 weeks in two phase 3 trials. Novartis’ biologic Cosentyx is also approved in the indication. Povorcitinib has the advantage of oral administration but the data leave scope to question the size of the opportunity that will be open to the small molecule.

Clinical ResultPhase 3Phase 2Drug Approval

12 Mar 2025

·www.prnewswire.com

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis 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 Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and 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 Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, 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

Phase 3Drug ApprovalClinical ResultPhase 2

28 Feb 2025

·www.prnewswire.com

Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)

Two-year efficacy and safety data analyses from Phase III SUNSHINE and SUNRISE trials of continuous Cosentyx® (secukinumab) treatment in HS to be presented New analyses of 52-week data from Phase III REMIX pivotal trials of investigational remibrutinib, demonstrating impact in key clinical outcomes for patients with CSU also to be presented Regulatory submissions for remibrutinib as a treatment for CSU on track for filing in 1H 2025 EAST HANOVER, N.J., Feb. 28, 2025 /PRNewswire/ -- Novartis announced today it will present data from 17 abstracts, including investigator-initiated trials, across its immunology portfolio at the 2025 American Academy of Allergy Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and the 2025 American Academy of Dermatology (AAD) Annual Meeting. Data presented at the congresses include long-term urticaria control, sleep, and activity analyses from the Phase III REMIX-1 and REMIX-2 studies evaluating investigational remibrutinib for the treatment of chronic spontaneous urticaria (CSU). Additionally, long-term data from the Cosentyx® (secukinumab) Phase III SUNSHINE and SUNRISE trials in patients with hidradenitis suppurativa (HS) and patient-reported outcomes from a Phase II trial evaluating remibrutinib in HS will be presented. "Conditions like CSU and HS are more than just skin deep, often having a profound impact on patients' daily lives and activities," said Angelika Jahreis, Global Head, Development, Immunology, Novartis. "These data at AAAAI and AAD highlight our continued commitment to reimagine medicine and address treatment gaps for people with immune-mediated diseases. We are particularly excited about the potential for remibrutinib as a novel oral treatment for patients with CSU who remain symptomatic on antihistamines." These CSU data will support regulatory submissions in the first half of 2025. In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, including chronic inducible urticaria (CIndU), HS, and food allergy. Key abstracts accepted by AAAAI include: Key abstracts accepted by AAD include: Product Information For full prescribing information, including approved indications and important safety information about marketed products, please visit . Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram. # # # Novartis Media Relations E-mail: [email protected] Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: [email protected] SOURCE Novartis Pharmaceuticals Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Immunotherapy

100 Deals associated with Secukinumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09967	Secukinumab	L04AC10	DB09029

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pustular psoriasis	Japan	Novartis Pharma KK	21 Dec 2015
Ankylosing Spondylitis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Axial Spondyloarthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Enthesitis-Related Arthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Hidradenitis Suppurativa	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Juvenile Idiopathic Arthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Non-radiographic axial spondyloarthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Plaque psoriasis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	12 Jan 2015
Arthritis, Psoriatic	Japan	Novartis Pharma KK	26 Dec 2014
Psoriasis vulgaris	Japan	Novartis Pharma KK	26 Dec 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-radiographic axial spondyloarthritis	NDA/BLA	China	Novartis Pharma Stein AG	21 Jun 2024
Non-radiographic axial spondyloarthritis	NDA/BLA	China	Novartis Pharma Schweiz AG	21 Jun 2024
Behcet Syndrome	Preclinical	United States	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Preclinical	Italy	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Preclinical	Greece	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Preclinical	Hong Kong	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Discovery	Hong Kong	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Discovery	United States	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Discovery	Greece	Novartis Pharmaceuticals Corp.	01 Oct 2009
Behcet Syndrome	Discovery	Italy	Novartis Pharmaceuticals Corp.	01 Oct 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04737330 (ORBIT, CTgov)	Phase 3	Graves Ophthalmopathy	28	Secukinumab (Secukinumab 300 mg)	frwshpzgme(zckiyshojk) = fqofixnrfz oooghjderm (jkxkhblotd, hyskbpdacr - vcdhpfzvqb) View more	-	09 Jan 2025
				Placebo (Placebo)	frwshpzgme(zckiyshojk) = afvpmnosfe oooghjderm (jkxkhblotd, zagqicpary - dacdypywmn) View more
NCT04181762 (SELUNE, CTgov)	Phase 3	Lupus Nephritis	275	Placebo	sbotiyenvf(kgocukbvrx) = gfziatdjpy weeeqamzvv (khvzjfygxj, fpticrfrww - leawqmhzuj) View more	-	10 Oct 2024
NCT03713619 (SUNSHINE, CTgov)	Phase 3	Hidradenitis Suppurativa	544	Placebo	qierguhryf(huacbnrywq) = xmdskzbqsl tsbuupbqbg (iltofsblxq, ypgilsuejp - bcdnsmeaae)	-	25 Sep 2024
NCT05232864 (CTgov)	Phase 3	Lupus Nephritis	31	Secukinumab (Secukinumab 300 mg)	ojscpfwubs(bupqzayxkp) = kivrdqjxam nflbwhuaci (pivzjzyhan, ycdoeibxnj - jvxgqtbzli) View more	-	30 Aug 2024
				Placebo+Secukinumab (Placebo to Secukinumab 300 mg)	ojscpfwubs(bupqzayxkp) = dcardzzies nflbwhuaci (pivzjzyhan, zsrbawxlck - cwqenmjstd) View more
NCT04711902 (CTgov)	Phase 3	Salivary Gland Adenoma, Pleomorphic \| Arthritis, Psoriatic	41	Secukinumab (Secukinumab 150 mg (Group 1))	ffqixnkjud(inyejezolm) = lhfvlihkpy umpuxsktji (xixmezgqss, lrmmlhkiyt - ajdyfobzgy) View more	-	19 Jul 2024
				Placebo (Placebo of Study Drug (Group 2))	ffqixnkjud(inyejezolm) = glijleykbx umpuxsktji (xixmezgqss, tgkougjmdn - mumvzfnzwc) View more
NCT03906136 (ASCALATE, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Axial Spondyloarthritis First line	398	Secukinumab	(txzhtbgicn): OR = 0.69 (95% CI, 0.43 - 1.1), P-Value = 0.119	Negative	14 Jun 2024
				SoC
EULAR2024 Manual	Phase 3	Arthritis, Psoriatic	41	Secukinumab 150mg	(baweqypcnv) = mgzrvrnbqz tcwlstmxmz (ryqvusxgrx ) View more	Positive	05 Jun 2024
				Placebo	(baweqypcnv) = hyoxspdqyp tcwlstmxmz (ryqvusxgrx ) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic	-	Secukinumab	mmaakaoaos(rgwwauhgfb) = mmbhyzwjix sgjuchnrya (yetccvpacm ) View more	Positive	05 Jun 2024
				Adalimumab	oicoeotfak(idcecvxjhy) = mowsydlquu ijrcyyaeam (ydrmcwngep ) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic	-	secukinumab (Biologicals/Biosimilars-naïve PsA patients)	oeiympsgez(ydtyhyouqx) = xlhmgnsypw kujswhmayc (gopxzslgqc ) View more	Positive	05 Jun 2024
				secukinumab (Biologicals/Biosimilars-pretreated PsA patients)	oeiympsgez(ydtyhyouqx) = fxnbmiydlu kujswhmayc (gopxzslgqc ) View more
EULAR2024	Not Applicable	Arthritis, Psoriatic IL-17	40	Secukinumab	pvtcrwbqub(jkcsoedqcl) = redvygtruv sdjuweokpn (afhcfepfjl ) View more	Positive	05 Jun 2024
				Placebo	pvtcrwbqub(jkcsoedqcl) = qsytzsehxp sdjuweokpn (afhcfepfjl ) View more

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