[Translation] A Phase IIb, Randomized, Controlled, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg versus Placebo in Patients with Active Lupus Nephritis

评估 Zetomipzomib 在活动性 III 或 IV 型（伴或不伴 V 型；III/IV +/-V 型）狼疮肾炎 (LN) 和单纯 V 型 LN 患者中的疗效和安全性。

[Translation]

To evaluate the efficacy and safety of zetomipzomib in patients with active class III or IV (with or without class V; class III/IV +/-V) lupus nephritis (LN) and isolated class V LN.

Start Date24 Apr 2024

Sponsor / Collaborator

Yunding Xinyao Pharmaceutical Technology Co., Ltd.

NCT05781750

/ TerminatedPhase 2

A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 Mg or 60 Mg with Placebo in Patients with Active Lupus Nephritis

The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

Start Date03 Nov 2023

Sponsor / Collaborator

Kezar Life Sciences, Inc.

NCT05569759

/ Active, not recruitingPhase 2

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With Open-label Extension to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis

This is a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis will receive zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allows patients to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.

Start Date23 May 2023

Sponsor / Collaborator

Kezar Life Sciences, Inc.

100 Clinical Results associated with Zetomipzomib

100 Translational Medicine associated with Zetomipzomib

100 Patents (Medical) associated with Zetomipzomib

Literatures (Medical) associated with Zetomipzomib

01 Mar 2024·Journal of dermatological science

Mass spectrometry -based proteomic analysis of the skin of patients with localized scleroderma

Letter

Author: Varjosalo, Markku ; Mähönen, Katariina ; Ranki, Annamari ; Panelius, Jaana ; Salokas, Kari ; Tuhkala, Antti ; Keskitalo, Salla

These results suggest the immunopro teasome to be a pot ential new therapeutic target in LS.The development of selective immunopro teasome inhibitors is underw ay with a dual immunoproteasome beta 5i/beta 2i selective inhibitor zetomipzomib in Phase II trials for lupus erythematosus and dermatomyositis/active polymyositis.These study patients were using methotrexate at the time of sampling, which could have potentially impacted the results.All patients, however, had active disease despite the medication.

01 Apr 2023·Drugs

Targeted Small Molecules for Systemic Lupus Erythematosus: Drugs in the Pipeline

Article

Author: Mok, Chi Chiu

Despite the uncertainty of the pathogenesis of systemic lupus erythematosus, novel small molecules targeting specific intracellular mechanisms of immune cells are being developed to reverse the pathophysiological processes. These targeted molecules have the advantages of convenient administration, lower production costs, and the lack of immunogenicity. The Janus kinases, Bruton's tyrosine kinases, and spleen tyrosine kinases are important enzymes for activating downstream signals from various receptors on immune cells that include cytokines, growth factor, hormones, Fc, CD40, and B-cell receptors. Suppression of these kinases impairs cellular activation, differentiation, and survival, leading to diminished cytokine actions and autoantibody secretion. Intracellular protein degradation by immunoproteasomes, levered by the cereblon E3 ubiquitin ligase complex, is an essential process for the regulation of cellular functions and survival. Modulation of the immunoproteasomes and cereblon leads to depletion of long-lived plasma cells, reduced plasmablast differentiation, and production of autoantibodies and interferon-α. The sphingosine 1-phosphate/sphingosine 1-phosphate receptor-1 pathway is responsible for lymphocyte trafficking, regulatory T-cell/Th17 cell homeostasis, and vascular permeability. Sphingosine 1-phosphate receptor-1 modulators limit the trafficking of autoreactive lymphocytes across the blood-brain barrier, increase regulatory T-cell function, and decrease production of autoantibodies and type I interferons. This article summarizes the development of these targeted small molecules in the treatment of systemic lupus erythematosus, and the future prospect for precision medicine.

01 Jan 2023·Frontiers in immunology

Zetomipzomib (KZR-616) attenuates lupus in mice via modulation of innate and adaptive immune responses.

Article

Author: Kirk, Christopher J. ; Fan, R. Andrea ; Muchamuel, Tony ; Anderl, Janet L. ; McMinn, Dustin L. ; Lowe, Eric ; Johnson, Henry W. B. ; Tuch, Brian B. ; Bomba, Darrin J. ; Millare, Beatriz

Zetomipzomib (KZR-616) is a selective inhibitor of the immunoproteasome currently undergoing clinical investigation in autoimmune disorders. Here, we characterized KZR-616 in vitro and in vivo using multiplexed cytokine analysis, lymphocyte activation and differentiation, and differential gene expression analysis. KZR-616 blocked production of >30 pro-inflammatory cytokines in human peripheral blood mononuclear cells (PBMCs), polarization of T helper (Th) cells, and formation of plasmablasts. In the NZB/W F1 mouse model of lupus nephritis (LN), KZR-616 treatment resulted in complete resolution of proteinuria that was maintained at least 8 weeks after the cessation of dosing and was mediated in part by alterations in T and B cell activation, including reduced numbers of short and long-lived plasma cells. Gene expression analysis of human PBMCs and tissues from diseased mice revealed a consistent and broad response focused on inhibition of T, B, and plasma cell function and the Type I interferon pathway and promotion of hematopoietic cell lineages and tissue remodeling. In healthy volunteers, KZR-616 administration resulted in selective inhibition of the immunoproteasome and blockade of cytokine production following ex vivo stimulation. These data support the ongoing development of KZR-616 in autoimmune disorders such as systemic lupus erythematosus (SLE)/LN.

News (Medical) associated with Zetomipzomib

03 Dec 2024

·www.prnewswire.com

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis 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 lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus 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 SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, 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

IND

13 Nov 2024

·endpts.com

89bio’s $125M offering; Another FDA hold for Kezar

Plus, news about Nippon Shinyaku, Atsena, Orna Therapeutics, Ovid Therapeutics, Graviton Bioscience, Eupraxia, Entero Therapeutics, Journey Therapeutics, Theravance Biopharma, Alpha Cognition and Travere Therapeutics: 89bio’s $125M offering: The liver and cardiometabolic biotech is selling shares $ETNB at $8.50 apiece, or about 55 cents below Tuesday’s closing price. Its stock slid nearly 10% on Tuesday. — Kyle LaHucik FDA places partial hold on Kezar study: The company is testing an immunoproteasome inhibitor called zetomipzomib in autoimmune hepatitis. The currently enrolled patients will be allowed to complete the trial, but four patients who are still in the blinded portion cannot proceed to the open-label extension. It’s the second hold for the drug since the start of October when another trial was placed on full clinical hold after four patients died. Topline data are expected in the first half of 2025. — Max Gelman Nippon Shinyaku licenses Atsena’s gene therapy in the US and Japan: Financial details of the deal were not disclosed, though Nippon Shinyaku will reimburse Atsena for continued development work for the rare eye disease treatment, including an expected pivotal study. Atsena also gets to keep the rights to a priority review voucher if it receives one. Nippon Shinyaku plans to market the therapy in the US via its subsidiary, NS Pharma. — Lei Lei Wu Orna cuts more staffers: The circular RNA-focused biotech told Endpoints News in a statement that it “restructured its team” as part of a broader pipeline prioritization, but did not disclose the number of cuts. The drugmaker previously laid off less than 25% of its staff in November 2023 in what it described as a “defensive reduction.” — Ayisha Sharma Ovid, Graviton pause starting Phase 2 trial: The companies are holding back from initiating their study of OV888 in people with cerebral cavernous malformations (CCM) to “evaluate clinical design learnings emerging from competitor” readouts. In September, Recursion Therapeutics’ CCM drug showed strong safety but mixed efficacy in a Phase 2 trial. — Ayisha Sharma Eupraxia touts additional Phase 1b/2a data: The company said that data from two cohorts of the trial, which is investigating EP-104GI as a treatment for eosinophilic esophagitis, showed reductions in the severity, symptoms and extent of the disease. In one cohort, a patient achieved complete histological remission. Eupraxia CEO James Helliwell said that “higher dosing levels are yielding improved patient responses.” — Katherine Lewin Entero’s reverse merger: The company is handing its Nasdaq spot to ADC biotech Journey Therapeutics three months after letting go of nearly all its employees and seeking strategic alternatives. Journey will get 99% of Entero’s equity, and its CEO Henry Ji will lead the combined company. — Kyle LaHucik Theravance forms strategic review committee: In its third-quarter financial results , the company said it would “assess all strategic alternatives,” including those related to its COPD drugs Yupelri and Trelegy. Theravance pulled in $16.9 million in revenue this quarter, but it all came from the Viatris collaboration for Yupelri. Along with announcing the review, Theravance separated the roles of board chair and CEO, naming Susannah Gray as chair while Rick Winningham will continue as CEO. The company made staff and program cuts last year. Its stock $TBPH was up about 11% on Wednesday morning. — Katherine Lewin Alpha Cognition prices $50M upsized public offering: The neuro biotech received a notice of allowance for its patent application covering its Alzheimer’s drug, called Zunveyl, through 2044. The funds from the public offering are expected to go toward the commercialization and launch of Zunveyl, R&D and other commercial and general corporate purposes. Zunveyl scored FDA approval in July. — Katherine Lewin Travere upsized its public offering . It raised a total of $143.8 million. — Jaimy Lee

Clinical ResultDrug ApprovalPhase 2Executive ChangeFinancial Statement

13 Nov 2024

·www.biospace.com

Kezar’s Autoimmune Drug Hit With Second FDA Clinical Hold in as Many Months

iStock, klenger Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate zetomipzomib faces a partial clinical hold barring four trial participants from continuing treatment in the open-label portion of the trial, though the trial itself will continue as planned. Kezar Life Sciences can’t catch a break this fall with its autoimmune candidate zetomipzomib. Just over a month after the FDA issued a clinical hold on zetomipzomib in lupus, the agency has placed a partial hold on a mid-stage trial of the drug in autoimmune hepatitis, Kezar said Tuesday in its Q3 business update . Last month, Kezar made the decision to discontinue the lupus program after four patient deaths occurred during the Phase IIb PALIZADE trial. Now, a partial clinical hold will block the remaining four patients in the double-blind treatment period (DBTP) of the Phase IIa PORTOLA trial in autoimmune hepatitis from continuing treatment with zetomipzomib by moving on to the open-label extension portion of the trial. The FDA is allowing enrolled participants to complete the 24-week DBTP and for those currently enrolled in the open-label extension to continue treatment. “This additional precaution was added to ensure any potential placebo patients still in the DBTP not be initiated on zetomipzomib, despite the IDMC recommending the PORTOLA trial proceed as planned and no reported adverse events of interest or deaths as seen in the PALIZADE trial,” William Blair analysts wrote in an investor note Wednesday. No Grade 4 or 5 serious adverse events have been observed in PORTOLA, according to Kezar. Kezar plans to report topline data from the PORTOLA trial in the first half of 2025. The William Blair analysts emphasized the importance of this readout. “Following discontinuation of the PALIZADE study during the quarter, there is clearly significant dependence on positive results from the PORTOLA study in the first half of 2025 to spur a reversal in share price,” they wrote. Kezar’s shares have been on a rollercoaster ride this year, falling from a high of $10.50 per share in February to a low of $5.20 per share in September. The company was trading at $7.28 per share pre-market Wednesday. Kezar CEO Chris Kirk said in October that the decision to discontinue the lupus program was difficult as the company had seen a favorable safety pro clinical activity in an earlier trial called MISSION. “However, a focused development effort in AIH [autoimmune hepatitis] extends our cash runway and provides flexibility as we work to bring zetomipzomib forward as a treatment for patients living with this life-threatening disease,” Kirk said in a statement at the time. Kezar had $148 million in cash, cash equivalents and marketable securities as of September 30.

Phase 2Clinical Trial Failure

100 Deals associated with Zetomipzomib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16070

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis, Autoimmune	Phase 2	United States	Kezar Life Sciences, Inc.	23 May 2023
Autoimmune Haemolytic Anaemias	Phase 2	United States	Kezar Life Sciences, Inc.	01 Jul 2020
Autoimmune Haemolytic Anaemias	Phase 2	Australia	Kezar Life Sciences, Inc.	01 Jul 2020
Autoimmune Haemolytic Anaemias	Phase 2	Italy	Kezar Life Sciences, Inc.	01 Jul 2020
Autoimmune Haemolytic Anaemias	Phase 2	Poland	Kezar Life Sciences, Inc.	01 Jul 2020
Autoimmune Haemolytic Anaemias	Phase 2	Russia	Kezar Life Sciences, Inc.	01 Jul 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	United States	Kezar Life Sciences, Inc.	01 Jul 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Australia	Kezar Life Sciences, Inc.	01 Jul 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Italy	Kezar Life Sciences, Inc.	01 Jul 2020
Purpura, Thrombocytopenic, Idiopathic	Phase 2	Poland	Kezar Life Sciences, Inc.	01 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05781750 (PALIZADE, Company_Website) Manual	Phase 2	Lupus Nephritis	-	zetomipzomib 30 mg	lfshkryajj(jisexjmyhe) = four fatal, or grade 5, serious adverse events among participants in the Philippines and Argentina, according to the release. yzjschnvfd (rtajvnhwqt )	Negative	01 Oct 2024
NCT05781750 (PALIZADE, Company_Website) Manual	Phase 2	Lupus Nephritis	-	zetomipzomib 60 mg		Negative	01 Oct 2024
NCT04628936 (CTgov)	Phase 2	Dermatomyositis	18	KZR-616	rkbyagwelt(necugzjrya) = clhguatnxp lufhkkqjay (lmxcvkcaux, 23.2) View more	-	05 Jun 2024
NCT04033926 (PRESIDIO, CTgov)	Phase 2	Dermatomyositis	25	Zetomipzomib (Arm A: Period 1 (Zetomipzomib))	luzhngajvu(wjullyrnjh) = qjzvoelioz hcgxkarcyj (qsupdceozw, 18.6) View more	-	03 Jan 2024
NCT04033926 (PRESIDIO, CTgov)	Phase 2	Dermatomyositis	25	Placebo (Arm B: Period 1 (Placebo))	luzhngajvu(wjullyrnjh) = ffjukmywib hcgxkarcyj (qsupdceozw, 19.9) View more	-	03 Jan 2024
NCT03393013 (MISSION, EULAR2023)	Phase 2	Lupus Nephritis proteinuria \| urinary CD163	21	Zetomipzomib 60 mg SC QW	uvtlktjebn(xxspoeytzc) = xzwjjappom rskcaulnsq (axmfsfmfly ) View more	-	31 May 2023
NCT03393013 (MISSION, EULAR2023)	Phase 2	Lupus Nephritis uCD163	21	Zetomipzomib 60mg	cqmjymfypt(gtbcgkedop) = ankbbhtegi criuylldgt (mnuowpaclt )	Positive	31 May 2023
NCT03393013 (MISSION, ASN2022) Manual	Phase 2	Lupus Nephritis	5	KZR-616	ituzhwcqan(drsraspqxr) = fpswpswzsc juwbmtzpht (qohtyqkksx ) View more	Positive	03 Nov 2022
NCT03393013 (MISSION, Biospace) Manual	Phase 2	Lupus Nephritis	17	Zetomipzomib	erzqhqkcre(brzozxyohe) = bfspejhxlt waswnufzlc (xxrwjzvxbm ) View more	Positive	27 Jun 2022
NCT04033926 (PRESIDIO, BusinessWire) Manual	Phase 2	Dermatomyositis \| Polymyositis	25	Zetomipzomib (Zetomipzomib+Zetomipzomib+placebo)	wlrwdmbfqc(ynxhaotbwt) = wscejaytkk qquisgezcr (kixgaqljfw ) View more	Negative	03 May 2022
NCT04033926 (PRESIDIO, BusinessWire) Manual	Phase 2	Dermatomyositis \| Polymyositis	25	Zetomipzomib (Zetomipzomib+placebo+Zetomipzomib)	wlrwdmbfqc(ynxhaotbwt) = ibmmrjoviw qquisgezcr (kixgaqljfw ) View more	Negative	03 May 2022
NCT03393013 (MISSION, BusinessWire) Manual	Phase 1	Systemic Lupus Erythematosus	47	Zetomipzomib	eznfujrdfs(ckazqwdpqa) = wsnhwftgpw amsoisdgco (rrhmtohkyb ) View more	Positive	02 Jun 2021
NZB/W Lupus Nephritis Model (ACR2019)	Not Applicable	Lupus Nephritis	-	KZR-616	kmhhashynm(uvgmqbcmgp) = dymhfiqwkn vmxhnaxjro (pphjxcpbgc )	Positive	10 Nov 2019

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