Novartis provides update on Phase III GCAptAIN study of Cosentyx® in giant cell arteritis (GCA)

The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1Safety in GCA patients was consistent with known safety profile of Cosentyx® (secukinumab)1 Basel, July 03, 2025 – Novartis today announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA). In the study, Cosentyx was evaluated in combination with a 26-week steroid taper and compared to placebo plus a 52-week steroid taper. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo. While the secondary outcomes did not show statistical superiority, Cosentyx showed numerically better outcomes compared to placebo for cumulative steroid dose and steroid-related toxicity1. Safety in GCA was consistent with the known safety profile of Cosentyx1, which is supported by robust evidence and 10 years of real-world data across its approved indications2-7. “While the Phase III results of GCAptAIN did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “We are grateful to the patients, investigators, and teams who made this study possible and will continue focusing on addressing areas of unmet medical need.” Novartis will complete a full evaluation of the GCAptAIN data and share the results at a later date. About GCAptAIN trial The GCAptAIN trial (NCT04930094) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with giant cell arteritis (GCA). Patients were randomized into three treatment arms: Cosentyx 300 mg, Cosentyx 150 mg, or placebo, all in combination with a glucocorticoid (GC) taper regimen. The primary endpoint of the trial is to assess whether secukinumab 300 mg s.c. plus a 26-week GC taper is superior to placebo plus a 52-week GC taper in achieving sustained remission at Week 52 and the first secondary endpoint is the cumulative GC dose through Week 528. About Cosentyx (secukinumab)Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS)9-11, as well as in pediatric patients with PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA)12,13.Cosentyx is supported by robust evidence and 10 years of real-world data demonstrating its long-term safety and sustained efficacy2-7. Since its launch in 2015, it has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries2. About giant cell arteritis (GCA) Giant cell arteritis (GCA) is the most common form of systemic vasculitis, primarily affecting people over 50 years of age14-16. Because of its potential to cause irreversible vision loss and life-threatening aortic aneurysms, GCA is considered a medical emergency requiring prompt recognition and treatment17-19. Beyond its physical complications, GCA significantly impairs quality of life, contributing to fatigue, cognitive difficulties, and reduced independence20-22. DisclaimerThis 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 https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Novartis Data on File Data on file_Cosentyx WW LTD patients Q1'25Uta Kiltz et al. Secukinumab Retention and Effectiveness in Patients with PsA and Radiographic Axial Spondyloarthritis: 5-year Final Results of a Prospective Real-world Study. Abstract no:2344. ACR 2024 [Link]Ippoliti et al. Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study. Dermatologic Therapy. 2025. Article Number: 9618241 [Link]Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pascale P, Delicha EM, Pricop L, Mpofu S. “Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5‑Year Efficacy and Safety Results from a Phase 3 Trial”. ACR/ARHP 2020 Annual Meeting Abstract. Presented in ACR Open Rheumatology (2020); CONCL‑00511 (Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study - PubMed)McInnes IB, Mease PJ, Kivitz AJ, Nash P, Rahman P, Rech J, Conaghan PG, Kirkham B, Navarra S, Belsare AD, Delicha EM, Pricop L, Mpofu S; FUTURE 2 Study Group. “Long‑term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5‑year (end‑of‑study) results from the phase III FUTURE 2 study.” Lancet Rheumatology. 2020; 2(4): e227–e235. (Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study)Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, Mazur R, Patekar M, Charef P, Milutinovic M, Leonardi C, Mrowietz U.Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018 Sep;32(9):1507–1514. (Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study) - PubMed)ClinicalTrials.gov. NCT04930094. [Last accessed: May 2025]. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: May 2025]. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724. Novartis AG. 2022. shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials [Last accessed: May 2025]. Novartis AG. 2021. Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: May 2025]. Novartis AG. 2022. Novartis Cosentyx® (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: May 2025]. González-Gay MA, García-Porrúa C. Medicine (Baltimore). 1999;78(5):292-308. Li KJ, et al. Arthritis Res Ther. 2021;23(1):82. Albrecht K, et al. Z Rheumatol. 2024;83(Suppl 1):20-30. Chen JJ, et al. Ophthalmology. 2016;123(9):1999-2003. Donaldson L, et al. Pract Neurol. 2022;22(2):138-140. Hayreh SS, et al. Am J Ophthalmol. 1998;125(4):509-520. de Boysson H, et al. Front Med (Lausanne). 2021;8:777310. Robson JC, et al. Rheumatology (Oxford). 2021;60(10):4671-4680. Martins-Martinho J, et al. Rheumatol Adv Pract. 2024;8(1):rkae013 # # #

Novartis provides update on Phase III GCAptAIN study of Cosentyx® in giant cell arteritis (GCA)

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