The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.

Start Date02 Sep 2020

Sponsor / Collaborator

Virginia Commonwealth University

[+1]

NCT04447469

/ CompletedPhase 2/3

A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Mavrilimumab (KPL-301) Treatment in Adult Subjects Hospitalized With Severe COVID-19 Pneumonia and Hyper-inflammation

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

Start Date28 Jul 2020

Sponsor / Collaborator

Kiniksa Pharmaceuticals International Plc

[+1]

NCT04397497

/ Unknown statusPhase 2IIT

A Randomized, Double Blind, Placebo-controlled Trial of Mavrilimumab for Acute Respiratory Failure Due to COVID-19 Pneumonia With Hyper-inflammation (the COMBAT-19 Trial)

This study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.

Start Date22 May 2020

Sponsor / Collaborator

Ospedale San Raffaele Srl

100 Clinical Results associated with Mavrilimumab

100 Translational Medicine associated with Mavrilimumab

100 Patents (Medical) associated with Mavrilimumab

Literatures (Medical) associated with Mavrilimumab

01 Sep 2026·EULAR Rheumatology Open

A systematic literature review to inform the 2025 EULAR recommendations for the management of polymyalgia rheumatica and primary large vessel vasculitis: management of disease including relapse and complications

Review

Author: Studenic, Paul ; Monti, Sara ; Mukhtyar, Chetan ; Nikiphorou, Elena ; Dey, Mrinalini ; Losasso, John ; Misra, Durga Prasanna ; Hellmich, Bernhard ; Bartoletti, Alice ; Ducker, Georgina

Objectives:

EULAR recommendations for polymyalgia rheumatica (PMR) and large vessel vasculitis (LVV) were published in 2015 and 2020, respectively. New evidence necessitated an update. We conducted a systematic literature review (SLR) to inform the 2025 EULAR recommendations for PMR and LVV.

Methods:

An SLR was conducted on MEDLINE, EMBASE, and CENTRAL on adults with PMR, giant cell arteritis (GCA), or Takayasu arteritis (TAK), using Medical Subject Heading terms related to management strategies on 31 December 2024 (PROSPERO: CRD42024560403). Eligible studies were randomised controlled trials (RCTs) and observational studies published since April 2014 (PMR) or December 2017 (LVV). EULAR 2024 and ACR 2024 abstracts were hand searched. Risk of bias (RoB) was assessed using Cochrane RoB-2 and the Newcastle-Ottawa Scale.

Results:

Of 141 included articles (30 RCTs), low RoB GCA RCTs showed superiority of secukinumab (phase II), mavrilimumab (phase II), and upadacitinib (phase III) vs placebo. Phase II trials of sarilumab and sirukumab were prematurely terminated. GiACTA secondary analyses reported similar tocilizumab efficacy across cranial and PMR symptoms, with better SF-36 and fatigue improvements than placebo. TAK RCTs reported similar effectiveness of methotrexate or mycophenolate (some concerns about RoB) and superiority of adalimumab over tocilizumab (high RoB). Phase III PMR RCTs showed tocilizumab and sarilumab superiority (low RoB) over placebo; smaller phase II studies supported rituximab (low RoB) and abatacept (some concerns about RoB). One high RoB RCT showed similar efficacy of tofacitinib and GCs.

Conclusions:

Multiple phase II and phase III RCTs inform the efficacy and safety of IL-6i, IL-17i, Janus kinase inhibitors, and B cell depletion in GCA and PMR; robust TAK trials remain lacking.

01 Sep 2026·AUTOIMMUNITY REVIEWS

Unraveling giant cell arteritis: From immunopathology to emerging targeted therapies (2026 update)

Review

Author: Parreau, Simon ; Ly, Kim ; Gallet, Francois ; Cayrou, Cory ; Bouanat, Sacha ; Fauchais, Anne-Laure

Giant cell arteritis (GCA) is the most common systemic vasculitis in the elderly mainly because of cellular senescence and "inflammaging" It results from granulomatous inflammation primarily affecting the aorta and its major branches. Recent advances highlight vascular dendritic cell (DC) activation via TLRs as the initiating event, leading to chemokine-mediated recruitment and polarization of CD4+ T cells mainly into Th1/Th17 subsets. These effector T cells drive monocyte differentiation into pro-inflammatory macrophages and giant cell formation, with subsequent matrix metalloproteinase production causing elastic lamina destruction and vascular remodeling. This vascular remodeling involves activation of endothelial cells, fibroblasts and smooth muscle cells followed by a differentiation in myofibroblast in the intima. Neutrophils may play an underestimated role. Current treatments remain limited to glucocorticoids, methotrexate and tocilizumab though relapse rates remain high. This narrative review synthesizes the DC-T-macrophage-fibroblast cascade and evaluates emerging biologics: abatacept showed phase 2 efficacy but real-world inferiority to tocilizumab; ustekinumab yielded conflicting results across small series; secukinumab failed phase 3 despite promising phase 2 data; anakinra lacked benefit in a truncated trial. In contrast, Mavrilimumab, an anti-GM-CSF-R, is showing promising results. JAK inhibitors such as upadacitinib (a JAK1 inhibitor; SELECT-GCA phase 3) are also promising, having demonstrated superior sustained remission compared with placebo, leading to regulatory approvals in 2025. These findings underscore opportunities to target upstream DC activation, macrophage polarization, and vascular remodeling pathways, potentially transforming GCA management beyond IL-6 inhibition.

01 Jun 2026·DRUGS

Large Vessel Vasculitis: Recent Advances in Pathophysiology and Targeted Therapies

Review

Author: Thiel, Jens ; Bosch, Philipp ; Reisch, Myriam

Large vessel vasculitides (LVV), including giant cell arteritis (GCA) and Takayasu arteritis (TAK), share common features such as inflammation of large sized arteries but differ in several key aspects, including age of onset and pathogenic mechanism. This narrative review gives an update of recent insights into pathogenesis of GCA and TAK, and discusses emerging targeted therapies based on these insights. It highlights omics-based signatures, ULK3 and SLAMF7 in GCA, EGR1 in TAK, alongside genetic and somatic risk factors such as clonal haematopoiesis (DNMT3A/TET2) linked to relapse and ischaemic vision loss in GCA, and the IL6R-p.Asp358Ala variant as a predictor of reduced interleukin (IL)-6 receptor blockade response. Common mechanisms include CD4⁺ T-cell, monocyte/macrophage, and B-cell infiltration with activation of IL-6, JAK/STAT/interferon, and IL-17 pathways. Giant cell arteritis is characterised by GM-CSF-driven macrophages and disrupted programmed cell death (PD)-1/PD-L1 checkpoint regulation, while TAK shows dominance of CD8⁺ T cells and tumour necrosis factor (TNF)-α signalling. Interleukin-6 receptor inhibitors (e.g., tocilizumab) show robust efficacy in GCA but with notable non-responders; the JAK inhibitor upadacitinib demonstrated efficacy in a Phase III study, whereas IL-17 blockade (secukinumab) yielded inconsistent results. In TAK, TNF inhibitors and tocilizumab are comparably effective; early data suggest Janus kinases (JAK) inhibitors promote remission, imaging improvement, and glucocorticoid sparing. Mavrilimumab (GM-CSF receptor blockade) is promising in GCA. Recent studies have increasingly focused on short-term glucocorticoid therapy in combination with biologic agents. Advances in biomarker research, including investigation of the IL-6 receptor and IL-17A gene polymorphisms, may enable more targeted therapeutic strategies.

News (Medical) associated with Mavrilimumab

12 Jun 2025

·www.einpresswire.com

Giant-Cell Arteritis Market Heats up with AbbVie’s RINVOQ Approval | DelveInsight

The FDA has approved AbbVie’s RINVOQ (upadacitinib) for the treatment of giant cell arteritis, making it the ninth approved indication for the drug. This also marks the first time an oral JAK inhibitor has been approved for this prevalent form of vasculitis in Western countries. RINVOQ’s approval has sparked competition among other pharmaceutical companies in the giant cell arteritis market. New York, USA, June 12, 2025 (GLOBE NEWSWIRE) -- Giant-cell Arteritis Market Heats up with AbbVie’s RINVOQ Approval | DelveInsight The FDA has approved AbbVie’s RINVOQ (upadacitinib) for the treatment of giant cell arteritis, making it the ninth approved indication for the drug. This also marks the first time an oral JAK inhibitor has been approved for this prevalent form of vasculitis in Western countries. RINVOQ’s approval has sparked competition among other pharmaceutical companies in the giant cell arteritis market. Giant-cell arteritis, also known as "Temporal Arteritis," is an inflammation of the arterial walls. It primarily affects arteries in the head, especially those near the temples, which is why it is often called temporal arteritis. In this condition, the temporal arteries, located on the sides of the head just in front of the ears, become inflamed. This inflammation causes the arteries to narrow, leading to reduced blood flow. According to DelveInsight’s analysis, patients over 80 years old represented the largest group of those living with giant-cell arteritis in the 7MM during 2023. The primary aim of treatment is to prevent serious complications, such as blindness. The standard therapy involves administering high doses of corticosteroids like prednisone, and prompt treatment is crucial to avoid vision loss or stroke. Learn more about the GCA treatment @ New Treatment for Giant-Cell Arteritis ACTEMRA/ROACTEMRA (tocilizumab) is a pioneering anti-IL-6 receptor (aIL-6R) therapy. Interleukin-6 (IL-6) is thought to be a major contributor to the inflammatory processes underlying rheumatoid arthritis (RA) and other autoimmune inflammatory diseases. By binding to and blocking the IL-6 receptor, ACTEMRA/ROACTEMRA helps reduce the activity of IL-6, leading to relief from joint pain, swelling, and other inflammation-related symptoms. The therapy is also approved for several other conditions, including pediatric juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), Giant-Cell Arteritis, and cytokine release syndrome (CRS) caused by CAR-T cell therapy. In September 2017, Roche announced that the European Commission (EC) approved ACTEMRA/ROACTEMRA for treating giant-cell arteritis, marking it as the first approved treatment for this condition in Europe. The decision was supported by results from the Phase III GiACTA study, which demonstrated that a weekly dose of the drug, combined with a six-month steroid taper, significantly improved sustained remission rates at one year, compared to steroid tapering alone. Later, in November 2018, Roche reported that the U.S. FDA approved the ACTPen autoinjector (162 mg/0.9 mL) as a new formulation of ACTEMRA for adult patients with giant-cell arteritis, offering an additional, more convenient administration option. Recently, in April 2025, AbbVie announced that the FDA had approved RINVOQ (upadacitinib) 15 mg, taken once daily, for treating adults with giant cell arteritis. This follows the recent marketing authorization granted by the European Commission for the same indication in adult patients. These approvals are based on data from the pivotal Phase 3 SELECT-GCA trial, which achieved its primary endpoint of sustained remission. Specifically, 46.4% of patients treated with RINVOQ 15 mg alongside a 26-week steroid taper reached sustained remission between weeks 12 and 52, compared to 29.0% of those on placebo with a 52-week taper (p=0.002). Throughout the 52-week, placebo-controlled study period, RINVOQ’s safety profile remained broadly consistent with its established safety in other approved uses. Find out more on FDA-approved GCA drugs @ Giant-Cell Arteritis Treatment Options Productive pharmacologic options for managing the most prevalent and most disabling phases of Giant-Cell Arteritis are minimal. Treatments that work in this disorder are scarce; therefore, new treatments are desperately needed. Some companies like Novartis (COSENTYX; secukinumab) and CSL/Kiniksa Pharmaceuticals (Mavrilimumab), among others, have initiated clinical trials that investigate new treatment options. Discover which therapies are expected to grab major GCA market share @ Giant-Cell Arteritis Market Report COSENTYX (secukinumab) is an injectable, fully human monoclonal antibody developed by Novartis Pharmaceuticals that targets and blocks interleukin-17A (IL-17A), a cytokine implicated in various immune-related disorders. It has received approval in both the United States and European Union for treating moderate-to-severe plaque psoriasis, active ankylosing spondylitis (AS) in adults, active non-radiographic axial spondyloarthritis (nr-axSpA), and active psoriatic arthritis (PsA) in adults. Secukinumab is an IgG1 monoclonal antibody that specifically binds to IL-17A, preventing its interaction with the IL-17 receptor. IL-17A plays a key role in regulating immune and inflammatory responses. By blocking this cytokine, secukinumab helps reduce the production of proinflammatory cytokines and chemokines. Novartis has completed a Phase II clinical trial for secukinumab in Giant-Cell Arteritis and is currently advancing the drug through Phase III trials for this indication. Discover more about drugs for GCA in development @ Giant-Cell Arteritis Clinical Trials The anticipated launch of these emerging therapies for GCA are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GCA market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for GCA is expected to grow from USD 960 million in the 7MM in 2023 at a significant CAGR by 2034. The growth of the giant-cell arteritis market is expected to be mainly driven by the growing geriatric population, the rise in the prevalence of cardiovascular disorders, technological advancements in the healthcare industry, and others. DelveInsight’s latest published market report, titled as Giant-Cell Arteritis Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GCA country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The GCA market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Giant-Cell Arteritis Total Subtype-specific Cases of Giant-Cell Arteritis Total Age group-specific Cases of Giant-Cell Arteritis Total Clinical Manifestation-specific Cases of Giant-Cell Arteritis Total Treated Cases of Giant-Cell Arteritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GCA 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 GCA market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs’ opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GCA market. Also, stay abreast of the mitigating factors to improve your market position in the GCA therapeutic space. Related Reports Giant-Cell Arteritis Pipeline Giant-Cell Arteritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key giant-cell arteritis companies, including Novartis, AbbVie, XOMA, Kiniksa Pharmaceuticals, Ltd., Eli Lilly and Company, Janssen Biotech, Dr Reddys Laboratories, among others. Giant-Cell Arteritis Epidemiology Forecast Giant-Cell Arteritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted giant-cell arteritis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Rheumatoid Arthritis Market Rheumatoid Arthritis 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 rheumatoid arthritis companies, including Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, among others. Rheumatoid Arthritis Pipeline Rheumatoid 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 rheumatoid arthritis companies, including Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Amgen, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, among others. Rheumatoid Arthritis Epidemiology Rheumatoid Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. 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 info@delveinsight.com +14699457679 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalPhase 3Phase 2ImmunotherapyClinical Result

26 Feb 2025

·www.biospace.com

Kiniksa Axes Sjögren’s Program, AstraZeneca-Licensed Antibody in Cardio Pivot

iStock, cagkansayin Kiniksa will now focus its development efforts on the IL-1 blocker KPL-387, which it is testing for recurrent pericarditis with Phase II/III trials planned for mid-2025. Kiniksa Pharmaceuticals will no longer move forward with its Sjögren’s syndrome drug development program and will walk away from an investigational antibody licensed from AstraZeneca, the London-based biotech announced on Tuesday. In Sjögren’s, Kiniksa was testing abiprubart, a monoclonal antibody that targets the CD40 protein, which is highly expressed in specific types of immune cells. In autoimmune diseases such as Sjögren’s, this mode of action could potentially disrupt pathological pathways that would otherwise culminate in a defective immune response that attacks healthy cells. Before being shelved, abiprubart was one of Kiniksa’s most mature assets. In July 2024, the biotech kicked off its Phase IIb study for the asset, testing biweekly and monthly dosing schedules in approximately 200 patients. The decision to discontinue abiprubart is in line with Kiniksa’s “strategic reprioritization of its portfolio and certain capital allocation considerations,” the biotech wrote in an SEC filing dated Feb. 21. The company will “immediately” stop enrollment into abiprubart’s mid-stage study and start winding down activities linked to the asset, while looking for strategic alternatives. Abiprubart’s termination has already cost Kiniksa $19 million, and the biotech expects to incur around $14 million to $17 million more in discontinuation expenses, mostly attributed to “contract termination costs” for existing supply agreements. Kiniksa expects to wrap up wind-down activities for abiprubart by the end of the year. Other players in the Sjögren’s syndrome space include J&J and Horizon Therapeutics , which reported respective mid-stage wins in June 2024 and January 2023. Also on Tuesday, Kiniksa announced it is terminating its licensing deal with AstraZeneca’s MedImmune for the GM-CSF blocker mavrilimumab. The asset, also a monoclonal antibody, was being tested for the chronic autoimmune disease giant cell arteritis and COVID-19-related acute respiratory distress syndrome. Kiniksa entered its licensing deal with MedImmune in December 2017, paying $23 million in upfront, pass-through and certain clinical milestone payments. At the time, the London biotech also promised up to $57.5 million in future milestones for the first two programs covered by the contract, plus up to $15 million for additional indications. In January 2024, however, Kiniksa announced it had slowed down investment into mavrilimumab and was in the process of looking for potential development partners for the asset. With abiprubart and mavrilimumab discontinued, Kiniksa is down to a completely cardiovascular pipeline —though the indication for its most immature candidate, the IL-1 antagonist KPL-1161, has yet to be disclosed. As per its Tuesday press release, Kiniksa will now focus its development efforts on KPL-387, also an IL-1 blocker, for recurrent pericarditis. The biotech is gearing up for a Phase II/III trial of the asset in mid-2025.

License out/inPhase 2Phase 1

25 Feb 2025

·www.fiercebiotech.com

Kiniksa adds to Sjögren\'s exodus with trial termination, axes AstraZeneca asset

In the wake of its recent pipeline decisions, Kiniksa is evaluating strategic alternatives for abiprubart.\n Kiniksa Pharmaceuticals is stopping development of a midphase autoimmune asset and returning a drug candidate to AstraZeneca as it doubles down on its cardiovascular disease pipeline.The asset licensed from AstraZeneca, GM-CSF antagonist mavrilimumab, was already on the back-burner, but the termination of the midphase autoimmune program comes as more of a shock. Six weeks ago, Kiniksa chief medical officer John Paolini, M.D., told investors the company was “certainly very excited” about a phase 2b trial of abiprubart in Sjögren’s syndrome. Today, Kiniksa said it is stopping the study.Kiniksa, which is evaluating strategic alternatives for abiprubart, framed the decision to end the trial as a result of a “strategic reprioritization of its portfolio and certain capital allocation considerations.” The action will cost $33 million to $37 million, Kiniksa said, but will free the biotech from the cost of funding a study that was scheduled to run into 2027.Abiprubart, an antibody that inhibits the signaling between CD40 and CD154, was in development in a competitive niche but Kiniksa had previously presented that as a positive. Last month, Kiniksa CEO Sanj Patel told investors “there has been some external derisking of the mechanism through other assets,” but he said abiprubart was differentiated through its monthly subcutaneous dosing.Amgen’s CD40L antagonist fusion protein, dazodalibep, is ahead of abiprubart in the race to market, with the big biotech starting phase 3 trials in Sjögren’s last year. But that drug is given intravenously.The high-concentration liquid formulation of abiprubart opened up the option of subcutaneous dosing. The list of rivals that Kiniksa believed may be able to offer subcutaneous dosing has thinned in recent years. Novartis axed its rival subcutaneous anti-CD40 antibody in Sjögren’s last month after assessing the risks and benefits of the molecule. Sanofi reached a similar decision in April, when it crossed Sjögren’s off the list of potential indications for its anti-CD40L prospect. Bristol Myers Squibb terminated a phase 1 trial of its CD40 candidate in Sjögren’s in 2023 because of “insufficient enrollment.” Kiniksa disclosed the winddown of its Sjögren’s trial, which it expects to complete by the end of the year, alongside the news that it is terminating development of mavrilimumab. The biotech licensed the asset from AstraZeneca’s MedImmune in 2017, paying $23 million in upfront and subsequent payments. But by early last year, the company was evaluating potential partnership opportunities to advance the molecule.The hunt for a partner ended last week, when Kiniksa told MedImmune it was stopping development of the asset and terminating the license agreement. Kiniksa’s actions leave it focused on a cardiovascular disease pipeline led by the IL-1 antagonist KPL-387. The program is targeting recurrent pericarditis, the same indication as Kiniksa’s approved drug Arcalyst, and a phase 2/3 trial is set to start this year.

$Kiniksa adds to Sjögren\'s exodus with trial termination, axes AstraZeneca asset$

License out/inPhase 2Phase 3Clinical Trial Termination

100 Deals associated with Mavrilimumab

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D09930	Mavrilimumab	-	DB12534

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	United States	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
COVID-19	Phase 3	Brazil	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
COVID-19	Phase 3	Chile	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
COVID-19	Phase 3	Peru	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
COVID-19	Phase 3	South Africa	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
Inflammation	Phase 3	United States	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
Inflammation	Phase 3	Brazil	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
Inflammation	Phase 3	Chile	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
Inflammation	Phase 3	Peru	Kiniksa Pharmaceuticals International Plc	28 Jul 2020
Inflammation	Phase 3	South Africa	Kiniksa Pharmaceuticals International Plc	28 Jul 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04492514 (CTgov)	Phase 2	Respiratory Failure \| COVID-19 \| Inflammation	1	Mavrilimumab (Mavrilimumab)	cunxfskffk = nijfejrhtm pemvchhjgh (rladvemqih, outlmkhawt - efxtclesmz) View more	-	09 Dec 2024
				Placebo (Placebo)	cunxfskffk = zigycylzgf pemvchhjgh (rladvemqih, bmdmlqxcan - ywordazbin) View more
NCT03827018 (CTgov)	Phase 2	Giant Cell Arteritis	70	prednisone+mavrilimumab (Mavrilimumab)	aiayatevjb(oytjtmyxti) = sjcaajpcvl tegoudnmys (zsrvawkkgo, fbadssbney - azmouiweqj) View more	-	17 Oct 2023
				placebo+prednisone (Placebo)	aiayatevjb(oytjtmyxti) = pnrdfbesdj tegoudnmys (zsrvawkkgo, efzhlmcmij - yzmkcykvsu) View more
NCT03827018 (Pubmed) Manual	Phase 2	Giant Cell Arteritis	70	mavrilimumab	zshwoinoao(erchfsqtqz) = frtbgoqrqa pfwcdjsrsr (uaarajeqmr ) View more	Positive	09 Mar 2022
				Placebo	zshwoinoao(erchfsqtqz) = xfxhzkphko pfwcdjsrsr (uaarajeqmr ) View more
NCT04463004 (CTgov)	Phase 2	Respiratory Failure \| COVID-19 \| Inflammation	2	Mavrilimumab (Intervention)	srhcetzxjy = jjqtlvjhqi mvofrqaizm (xjonyrclic, ndmkcfeaqd - tulaspludy) View more	-	11 Aug 2021
				Placebos (Control)	srhcetzxjy = rpbsndlsak mvofrqaizm (xjonyrclic, xlgbrxunws - eitfheqnst) View more
EULAR2021	Phase 2	Giant Cell Arteritis	70	Mavrilimumab 150 mg	feinqtjnnx(eahyuvsmqk) = moeurwhrvm azuqghjjlu (frleruedby, 67.9 - 91.6)	Positive	02 Jun 2021
				Placebo	feinqtjnnx(eahyuvsmqk) = vlwfbigzzo azuqghjjlu (frleruedby, 29.6 - 67.3)
Phase 2 Trial of Mavrilimumab (EULAR2021)	Phase 2	Giant Cell Arteritis C-reactive protein \| erythrocyte sedimentation rate	70	Mavrilimumab 150mg	zodmsrgdtd(irwckcrpfd) = zqcqqpagnt mdlmsxqgso (twjmxftjye ) View more	-	02 Jun 2021
				Placebo	zodmsrgdtd(irwckcrpfd) = ymawmapmhf mdlmsxqgso (twjmxftjye ) View more
NCT04492514 \| NCT04463004 \| NCT04399980 (Pubmed \| Lancet Rheumatol) Manual	Phase 2	COVID-19	40	Mavrilimumab	uwscrqmwog(dfdqxwtwis) = ibbnwbhjui qmuehoypmc (ctygyjdnvq )	Negative	01 Jun 2021
				Placebo	uwscrqmwog(dfdqxwtwis) = lhepjafmlu qmuehoypmc (ctygyjdnvq )
NCT04399980 (CTgov)	Phase 2	Respiratory Failure \| COVID-19 \| Inflammation	40	Mavrilimumab (Intervention)	kfszqspxus = icicdjwmcn ckycuwqxck (xnmstqvlbt, ffyogxabji - rtmqrtrbkp) View more	-	13 May 2021
				Placebos (Control)	kfszqspxus = nmiawmruvf ckycuwqxck (xnmstqvlbt, hpwacpnupj - wmbzqsrzpj) View more
NCT04447469 (Corporate Publications) Manual	Phase 2	COVID-19	116	Standard of Care+Mavrilimumab	eigimryilv(gklctcuudg) = rvzahdzknv teqrikmvxv (nkwvumxhmj ) View more	Positive	12 Apr 2021
				Placebo+Standard of Care	eigimryilv(gklctcuudg) = fetuvxtuql teqrikmvxv (nkwvumxhmj ) View more
NCT04399980 (Corporate Publications) Manual	Phase 2	COVID-19 \| Inflammation	40	mavrilimumab	zjpxvfcmzn(ecjbatsvlx) = urqjbzrujs zubjhyznhq (pheqccfujf ) View more	Positive	22 Dec 2020
				Placebo	zjpxvfcmzn(ecjbatsvlx) = rbcdektoej zubjhyznhq (pheqccfujf ) View more

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis