A Phase II Trial to Evaluate the Safety and Efficacy of clazakizumab for the desensitisation of highly sensitized patients on the deceased donor kidney transplant waiting list

Start Date06 May 2024

Sponsor / Collaborator

Royal Melbourne Hospital

NCT05727384 / RecruitingPhase 2IIT

Reducing Inflammation for Greater Health Trial: The RIGHT Study

The goal of this clinical trial is to learn about the effects of inflammation-lowering therapy on mobility and disability in older adults. The main questions it aims to answer are:
Will therapy improve walking speed/pace?
Will therapy improve levels of blood inflammation markers and other indicators of physical, cognitive and immune function?
Participants will be asked to receive injections of drug or placebo every 4 weeks for 24 weeks. They will also be asked to undergo testing that assesses physical function, thinking ability and brain health, breathing capacity, and blood vessel stiffness, and will have blood samples collected to measure immune function and to create a bank of samples for future testing. Comparisons will be made between those who receive drug and those who receive placebo.

Start Date01 Aug 2023

Sponsor / Collaborator

CSL Behring LLC

NCT05485961 / Enrolling by invitationPhase 2/3

A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double blind, placebo controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on CV outcomes and safety in subjects with ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.

Start Date21 Oct 2022

Sponsor / Collaborator

CSL Behring LLC

100 Clinical Results associated with Clazakizumab

100 Translational Medicine associated with Clazakizumab

100 Patents (Medical) associated with Clazakizumab

Literatures (Medical) associated with Clazakizumab

01 Feb 2023·Transplantation

Anti-interleukin-6 Antibody Clazakizumab in Antibody-mediated Renal Allograft Rejection: Accumulation of Antibody-neutralized Interleukin-6 Without Signs of Proinflammatory Rebound Phenomena

Article

Author: Mayer, Katharina A ; Eskandary, Farsad ; Chong, Edward ; Haindl, Susanne ; Halloran, Philip F ; Wahrmann, Markus ; Mühlbacher, Jakob ; Borski, Anita ; Budde, Klemens ; Jilma, Bernd ; Böhmig, Georg A ; Doberer, Konstantin

Background.:

Blockade of interleukin-6 (IL-6) has emerged as a promising therapeutic option for antibody-mediated rejection. Subtherapeutic anti-IL-6 antibody level or treatment cessation following prolonged cytokine neutralization may result in proinflammatory rebound phenomena via accumulation of IL-6 and/or modulated gene expression of major components of the IL-6/IL-6 receptor (IL-6R) axis.

Methods.:

We evaluated biologic material obtained from a randomized controlled, double-blind phase 2 trial designed to evaluate the safety and efficacy of the anti-IL-6 monoclonal antibody clazakizumab in late antibody-mediated rejection. Twenty kidney transplant recipients, allocated to clazakizumab or placebo, received 4-weekly doses over 12 wks, followed by a 40-wk extension where all recipients received clazakizumab. Serum proteins were detected using bead-based immunoassays and RNA transcripts using quantitative real-time polymerase chain reaction (peripheral blood) or microarray analysis (serial allograft biopsies).

Results.:

Clazakizumab treatment resulted in a substantial increase in median total (bound and unbound to drug) serum IL-6 level (1.4, 8015, and 13 600 pg/mL at 0, 12, and 52 wks), but median level of free (unbound to drug) IL-6 did not increase (3.0, 2.3, and 2.3 pg/mL, respectively). Neutralization of IL-6 did not boost soluble IL-6R or leukocyte or allograft expression of IL-6, IL-6R, and glycoprotein 130 mRNA. Cessation of treatment at the end of the trial did not result in a meaningful increase in C-reactive protein or accelerated progression of graft dysfunction during 12 mo of follow-up.

Conclusion.:

Our results argue against clinically relevant rebound phenomena and modulation of major components of the IL-6/IL-6R axis following prolonged IL-6 neutralization with clazakizumab.

01 Dec 2022·Nephrologie & therapeutique

Article

Author: Jouve, Thomas ; Rostaing, Lionel ; Noble, Johan ; Weinhard, Jules ; Malvezzi, Paolo

BACKGROUND:

Desensitization allows kidney transplantation for HLA highly sensitized subjects. Due to the central role of IL-6 in immunological response, tocilizumab (monoclonal antibody directed against IL-6 receptor) could probably improve desensitization efficacy.

METHODS:

Pubmed systematic review by using MeSH terms: tocilizumab, clazakizumab, interleukin-6 blockade, kidney transplantation, kidney graft and desensitization.

STUDIES:

IL-6 plays a role in humoral response (plasmocyte differentiation induced by lymphocyte T, IL-21 secretion) as well as in cellular response (differentiation of LT Th17 rather than T reg). In desensitization field, tocilizumab was first studied as second-line treatment after failing of standard-of-care (apheresis, rituximab ± IgIV). Recent study showed that tocilizumab as a monotherapy attenuated anti-HLA antibodies rates but was not sufficient to allow transplantation. However, lymphocyte immunophenotyping showed that tocilizumab hindered B cells maturation. Thereby, tocilizumab could improve long-term efficacy of desensitization, by limiting the anti-HLA rebound and so avoiding antibody-mediated rejection. This hypothesis is supported by a recent study which used clazakizumab (monoclonal antibody directed against IL-6) in association with standard-of-care. In that study, clazakizumab was continued after kidney transplantation. Results were encouraging because 9/10 patients were transplanted and there was no donor-specific antibody at 6 months post-transplantation.

CONCLUSION:

IL-6 pathway blockade as a monotherapy fails to desensitize HLA highly sensitized kidney transplant candidates. In association with standard-of-care, it does not seem to significatively improve kidney allograft access (short-term efficacy) vs. standard-of-care only. However, it could improve long-term prognosis of HLA incompatible transplantation by orienting the response towards a tolerogenic profile, by hindering B-cell maturation and, thereby, avoiding DSA rebounds after transplantation. This hypothesis needs to be proven by further studies.

01 Dec 2022·American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

Importance of IL-6 inhibition in prevention and treatment of antibody-mediated rejection in kidney allografts

Article

Author: Huang, Edmund ; Jordan, Stanley C ; Ammerman, Noriko ; Vo, Ashley

Interleukin-6 (IL-6) is a cytokine critical for innate and adaptive immune responses. However, persistent expression of high levels of IL-6 are associated with a number of pathologic conditions including autoimmune diseases and capillary leak syndrome. Importantly, in kidney transplant patients, IL-6 may play a role in mediation of cell-mediated rejection (CMR) and antibody-mediated rejection (AMR). This is likely due to the importance of IL-6 in stimulating B cell responses with pathogenic donor-specific antibody (DSA) generation and stimulation of T effector cell responses while inhibiting T regulatory cells. Data from preliminary clinical trials and clinical observations show that tocilizumab (anti-IL-6R) and clazakizumab (anti-IL-6) may have promise in treatment of CMR, AMR and chronic (cAMR). This has led to a phase 3 placebo, randomized clinical trial of clazakizumab for treatment of cAMR, a condition for which there is currently no treatment. The identification of IL-6 production in vascular endothelia cells after alloimmune activation reveals another potential pathway for vasculitis as endothelia cell IL-6 may stimulate immune cell responses that are potentially inhibitable with anti-IL-6/IL-6R treatment. Importantly, anti-IL-6/IL-6R treatments have shown the ability to induce Treg and Breg cells in vivo which may have potential importance for prevention and treatment of DSA development and allograft rejection.

News (Medical) associated with Clazakizumab

02 Nov 2022

·www.prnewswire.com

Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead MELBOURNE, Australia and KING OF PRUSSIA, Pa., Nov. 2, 2022 /PRNewswire/ -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is well-positioned to meet the current and future needs of patients and public health. CSL revealed progress and plans in advancing assets that have the potential to disrupt current standards of care in its areas of focus (immunology, haematology, respiratory, cardiovascular and metabolic, transplant, nephrology, vaccines) using its strategic scientific platforms (plasma protein technology, recombinant technology, cell and gene therapy, and sa-mRNA, adjuvanted, cell-based and egg-based vaccines). Among the highlights presented were the following: Late-Stage Development Includes Disruptive Innovation and New Additions to the CSL Portfolio Etranacogene dezaparvovec (also known as CSL222), an investigational gene therapy for the treatment of adults with haemophilia B has been accepted for priority review by the United States (US) Food and Drug Administration (FDA) and standard review by the European Medicines Agency (EMA). If approved, etranacogene dezaparvovec would be the first-ever gene therapy treatment option for the haemophilia B community. The regulatory filings are supported by results from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The multi-year clinical development program for etranacogene dezaparvovec was led by uniQure (Nasdaq: QURE) and sponsorship of the clinical trials has transitioned to CSL after acquiring global rights to commercialize the investigational treatment. Top-line Phase III results for garadacimab (CSL312, anti-FXIIa), an investigational first-in-class monoclonal antibody being developed as a long-term preventive treatment for patients with hereditary angioedema, demonstrated that the study met its primary and secondary efficacy objectives and showed favourable safety and tolerability. CSL aims to begin filing for approval with global regulatory authorities next calendar year. Garadacimab was discovered and optimised by scientists at CSL's Bio21–based Research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. CSL Vifor brings a leading portfolio of therapies in nephrology, dialysis and iron deficiency. New late-stage assets to the pipeline include Sparsentan for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) and SNF472 for calciphylaxis and calcific uremic arteriolopathy (CUA). R&D Portfolio Progress Across Areas of Focus and Scientific Platforms Clazakizumab, an anti-IL6 monoclonal antibody, intended for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients continues to progress in the Phase III IMAGINE trial. This is CSL's leading program for clazakizumab, which will also be investigated in a Phase IIb/III study for improvement of cardiovascular (CV) outcomes in dialysis patients. CSL plans to engage Fresenius Medical Care dialysis centres in the study. AEGIS-II, a Phase III, multicenter, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112, compared to placebo, in reducing the risk of major adverse CV events (MACE) in patients following a heart attack, will enrol the last patient by the end of 2022, with completion of the trial expected towards the end of 2023. CSL is advancing the Phase IIb study for its adjuvanted, cell-based high-dose quadrivalent influenza vaccine (aQIVc). This study will help CSL further build the body of clinical evidence to support the optimal formulation for when the company moves into the Phase III immunogenicity and safety study for aQIVc. Published results from the preclinical studies of CSL's self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines, indicate a potent, cross-reactive immune response against pandemic and seasonal influenza strains, A(H5N1) and A(H1N1). CSL's sa-mRNA candidate is expected to enter clinical trials in 2023. Recently Announced Collaboration and license agreement with Arcturus Therapeutics aims to accelerate next-generation mRNA capabilities in influenza, pandemic preparedness and other selected respiratory viral pathogens -- including a near term COVID-19 vaccine that has recently reported interim results from a large Phase III efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favourable safety profile. A strategic option and license agreement with Translational Sciences to license TS23, a first-in-class anti-α2-antiplasmin monoclonal antibody. TS23 is being developed to dissolve thrombi that cause serious conditions such as pulmonary embolism (PE) and acute ischemic stroke (AIS). The treatment candidate is soon to be evaluated in the US in the NAIL-IT Phase II study, which has been designed to evaluate the safety and thrombolytic effect of ascending doses of TS23 in patients with sub-massive (intermediate risk) PE. "CSL is on the leading-edge of innovation in areas we know well and we have strategically and methodically built a pipeline that has never been more robust with diverse sources of innovation, from in-house and external sources, that include the disruptive scientific platforms of gene therapy and sa-mRNA," said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, and Chief Medical Officer for CSL. "Our enhanced capabilities across all of our scientific platforms and therapeutic focus areas will help us in our relentless pursuit to deliver on our promise to help patients lead full lives, protect public health and sustainably grow our business in the decades ahead, while providing promising futures for our employees." In fiscal year 2021-2022, CSL invested approximately $1.16 billion in R&D. This includes growing CSL R&D's footprint in Melbourne, Australia; Marburg, Germany; throughout Switzerland and Waltham, Massachusetts – helping to create an integrated global organization that can conveniently collaborate with institutions everywhere -- offering scientists a wide array of opportunities for professional development and enhancing access to external innovation. Advancing External Innovation: The Biotechnology Incubator at CSL's Global Headquarters in Melbourne, Australia Names Its Operator CSL, WEHI and The University of Melbourne have appointed Cicada Innovations as the independent operator of the new biotech incubator which will be located in CSL's new global headquarters currently under construction in the Melbourne Biomedical Precinct. The appointment follows the project partners joining forces to create an incubator for biotech start-up companies, with the Victorian Government's landmark Breakthrough Victoria Fund providing funding to support the AU$95 million project. It will be Australia's first and only incubator that is co-located with a leading biopharmaceutical company and will have space for up to 40 start-ups. "Incubator residents will be working in an innovation-driven environment alongside a large and focused CSL R&D team, enabling opportunities for peer-collaboration, learning and sharing of ideas," said Dr. Andrew Nash, CSL's Chief Scientific Officer and Senior Vice President, Research. "The strong collaboration between CSL, the University of Melbourne, WEHI, Breakthrough Victoria and now Cicada Innovations has been critical to bring the incubator to fruition and reflects CSL's values and desire to deliver on our promise to patients worldwide." For more about the incubator, . For more on CSL's R&D Investor Briefing, please visit . About CSL CSL Limited (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs more than 30,000 people. Our unique combination of commercial strength, R&D focus, and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information visit . Media Contacts: Greg Healy Email: [email protected] +1 610 906 4564 In Australia: Jimmy Baker Email: [email protected] +61 450 909 211 Kim O'Donohue Email: [email protected] +61 449 884 603 In Europe: Jasmin Joller Email: [email protected] SOURCE CSL

VaccineCollaborateGene TherapyAntibodyFinancial Statement

02 Nov 2022

·www.biospace.com

Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead MELBOURNE, Australia and KING OF PRUSSIA, Pa., Nov. 2, 2022 /PRNewswire/ -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is well-positioned to meet the current and future needs of patients and public health. CSL revealed progress and plans in advancing assets that have the potential to disrupt current standards of care in its areas of focus (immunology, haematology, respiratory, cardiovascular and metabolic, transplant, nephrology, vaccines) using its strategic scientific platforms (plasma protein technology, recombinant technology, cell and gene therapy, and sa-mRNA, adjuvanted, cell-based and egg-based vaccines). Among the highlights presented were the following: Late-Stage Development Includes Disruptive Innovation and New Additions to the CSL Portfolio Etranacogene dezaparvovec (also known as CSL222), an investigational gene therapy for the treatment of adults with haemophilia B has been accepted for priority review by the United States (US) Food and Drug Administration (FDA) and standard review by the European Medicines Agency (EMA). If approved, etranacogene dezaparvovec would be the first-ever gene therapy treatment option for the haemophilia B community. The regulatory filings are supported by results from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The multi-year clinical development program for etranacogene dezaparvovec was led by uniQure (Nasdaq: QURE) and sponsorship of the clinical trials has transitioned to CSL after acquiring global rights to commercialize the investigational treatment. Top-line Phase III results for garadacimab (CSL312, anti-FXIIa), an investigational first-in-class monoclonal antibody being developed as a long-term preventive treatment for patients with hereditary angioedema, demonstrated that the study met its primary and secondary efficacy objectives and showed favourable safety and tolerability. CSL aims to begin filing for approval with global regulatory authorities next calendar year. Garadacimab was discovered and optimised by scientists at CSL's Bio21–based Research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. CSL Vifor brings a leading portfolio of therapies in nephrology, dialysis and iron deficiency. New late-stage assets to the pipeline include Sparsentan for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) and SNF472 for calciphylaxis and calcific uremic arteriolopathy (CUA). R&D Portfolio Progress Across Areas of Focus and Scientific Platforms Clazakizumab, an anti-IL6 monoclonal antibody, intended for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients continues to progress in the Phase III IMAGINE trial. This is CSL's leading program for clazakizumab, which will also be investigated in a Phase IIb/III study for improvement of cardiovascular (CV) outcomes in dialysis patients. CSL plans to engage Fresenius Medical Care dialysis centres in the study. AEGIS-II, a Phase III, multicenter, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112, compared to placebo, in reducing the risk of major adverse CV events (MACE) in patients following a heart attack, will enrol the last patient by the end of 2022, with completion of the trial expected towards the end of 2023. CSL is advancing the Phase IIb study for its adjuvanted, cell-based high-dose quadrivalent influenza vaccine (aQIVc). This study will help CSL further build the body of clinical evidence to support the optimal formulation for when the company moves into the Phase III immunogenicity and safety study for aQIVc. Published results from the preclinical studies of CSL's self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines, indicate a potent, cross-reactive immune response against pandemic and seasonal influenza strains, A(H5N1) and A(H1N1). CSL's sa-mRNA candidate is expected to enter clinical trials in 2023. Recently Announced Collaboration and license agreement with Arcturus Therapeutics aims to accelerate next-generation mRNA capabilities in influenza, pandemic preparedness and other selected respiratory viral pathogens -- including a near term COVID-19 vaccine that has recently reported interim results from a large Phase III efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favourable safety profile. A strategic option and license agreement with Translational Sciences to license TS23, a first-in-class anti-α2-antiplasmin monoclonal antibody. TS23 is being developed to dissolve thrombi that cause serious conditions such as pulmonary embolism (PE) and acute ischemic stroke (AIS). The treatment candidate is soon to be evaluated in the US in the NAIL-IT Phase II study, which has been designed to evaluate the safety and thrombolytic effect of ascending doses of TS23 in patients with sub-massive (intermediate risk) PE. "CSL is on the leading-edge of innovation in areas we know well and we have strategically and methodically built a pipeline that has never been more robust with diverse sources of innovation, from in-house and external sources, that include the disruptive scientific platforms of gene therapy and sa-mRNA," said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, and Chief Medical Officer for CSL. "Our enhanced capabilities across all of our scientific platforms and therapeutic focus areas will help us in our relentless pursuit to deliver on our promise to help patients lead full lives, protect public health and sustainably grow our business in the decades ahead, while providing promising futures for our employees." In fiscal year 2021-2022, CSL invested approximately $1.16 billion in R&D. This includes growing CSL R&D's footprint in Melbourne, Australia; Marburg, Germany; throughout Switzerland and Waltham, Massachusetts – helping to create an integrated global organization that can conveniently collaborate with institutions everywhere -- offering scientists a wide array of opportunities for professional development and enhancing access to external innovation. Advancing External Innovation: The Biotechnology Incubator at CSL's Global Headquarters in Melbourne, Australia Names Its Operator CSL, WEHI and The University of Melbourne have appointed Cicada Innovations as the independent operator of the new biotech incubator which will be located in CSL's new global headquarters currently under construction in the Melbourne Biomedical Precinct. The appointment follows the project partners joining forces to create an incubator for biotech start-up companies, with the Victorian Government's landmark Breakthrough Victoria Fund providing funding to support the AU$95 million project. It will be Australia's first and only incubator that is co-located with a leading biopharmaceutical company and will have space for up to 40 start-ups. "Incubator residents will be working in an innovation-driven environment alongside a large and focused CSL R&D team, enabling opportunities for peer-collaboration, learning and sharing of ideas," said Dr. Andrew Nash, CSL's Chief Scientific Officer and Senior Vice President, Research. "The strong collaboration between CSL, the University of Melbourne, WEHI, Breakthrough Victoria and now Cicada Innovations has been critical to bring the incubator to fruition and reflects CSL's values and desire to deliver on our promise to patients worldwide." For more about the incubator, . For more on CSL's R&D Investor Briefing, please visit . About CSL CSL Limited (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs more than 30,000 people. Our unique combination of commercial strength, R&D focus, and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information visit . In Europe: Jasmin Joller Email: jasmin.joller@cslbehring.com Company Codes: Australia:CSL, OTC-PINK:CSLLY, OTC-BB:CSLLY

VaccineCollaborateGene TherapyAntibodyFinancial Statement

100 Deals associated with Clazakizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10312	Clazakizumab	-	DB12849

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Antibody-mediated rejection	Phase 3	US	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	AU	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	AT	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	BE	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	CA	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	CZ	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	FR	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	DE	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	HU	CSL Behring LLC	14 Oct 2019
Antibody-mediated rejection	Phase 3	NL	CSL Behring LLC	14 Oct 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03444103 (Pubmed)	Phase 2	Renal transplant rejection	20	Clazakizumab	owagprmhag(dkbcgiqixl) = qpwicytbpv zwnrecpnkj (httqnxkmrv, 0.91% - 2.78%) View more	-	01 Dec 2022
				Placebo	owagprmhag(dkbcgiqixl) = wufwltduhd zwnrecpnkj (httqnxkmrv, 0.56% - 2.30%) View more
Pubmed	Phase 2	Renal transplant rejection	-	Clazakizumab	nauyqxdzls(gtuhistnav) = nldchhimlp apcqofrutn (hleovqezyw ) View more	-	15 Aug 2022
NCT04348500 (Pubmed) Manual	Phase 2/3	COVID-19 \| Pneumonia	152	clazakizumab	zvvadhfyam(ehscweytsc): OR = 3.84 View more	Positive	18 May 2022
				Placebo
NCT04381052 (CTgov)	Phase 2	COVID-19	1	Clazakizumab (Clazakizumab 25 mg)	qxkmebfrwp(zovargtday) = dvksfxqxxx fdwebiilre (vbvmlocvxm, sysmsadmkx - qfkmmxrruy) View more	-	08 Apr 2022
				Placebo (Placebo)	qxkmebfrwp(zovargtday) = qgqvmgpayl fdwebiilre (vbvmlocvxm, pcdssrbihp - puwtungaso) View more
NCT03744910 (Pubmed \| Kidney Int Rep)	Phase 2	-	10	Clazakizumab 25 mg	lxmxcyaozr(ncespsehry) = evptbkurgk eghbhwiiha (jgkvflqlno )	Positive	01 Apr 2022
NCT04343989 (CTgov)	Phase 2	COVID-19	178	Clazakizumab 25 mg (Clazakizumab 25 mg)	xlaplalncm(czjwpztdum) = wfrhgpizbr gworcatent (hebtleypzj, zftnvfkvdi - onqddwnjpz) View more	-	15 Feb 2022
				Clazakizumab 12.5 mg (Clazakizumab 12.5 mg)	xlaplalncm(czjwpztdum) = xrwmqgwtdh gworcatent (hebtleypzj, cjowojypew - dvyzfgwogo) View more
NCT01373151 (CTgov)	Phase 2	Rheumatoid Arthritis	418	Placebo+MTX (Placebo+MTX)	gngxqglwnh(gjeztlflrv) = iovanpzqxd kqqbweclok (ufmbkxooqg, juzhrrnsmz - eldkzgxmic) View more	-	06 Dec 2021
				Clazakizumab+MTX (Clazakizumab(25)+MTX)	gngxqglwnh(gjeztlflrv) = roynageagl kqqbweclok (ufmbkxooqg, ukdwxurkbw - typhgymvmm) View more
NCT04348500 (CTgov)	Phase 2	COVID-19	17	Clazakizumab (Clazakizumab)	tlzudgjvpb(gszqxsoiyc) = dcqwwzkurj azfnaunedu (svarvfreql, kpwkcbznhc - uioflydayg) View more	-	02 Dec 2021
				Clazakizumab (Placebo)	tlzudgjvpb(gszqxsoiyc) = ylsgwawozb azfnaunedu (svarvfreql, rqtxehocab - mcvuzumboi) View more
NCT01403064 (CTgov)	Phase 2	Stomatitis \| Head and Neck Neoplasms	76	0.9% saline	vvziohqejd(vueykbsdkq) = lxxtuxttes weigrjlbjp (dhwubexbiy, oawnrxguzr - vsahfxlqqh) View more	-	11 May 2021
NCT02015520 (CTgov)	Phase 2	Rheumatoid Arthritis	143	Placebo (Placebo + Methotrexate (MTX))	rmnjmlwwns(sgjdqmanvm) = tdntrnaavh mqvvsqvhtp (itbdjcvilz, tzqnydhkhj - jjexsrksaj) View more	-	19 Apr 2021
				Clazakizumab+MTX (Clazakizumab (1 mg) + MTX)	rmnjmlwwns(sgjdqmanvm) = lztfdojqyr mqvvsqvhtp (itbdjcvilz, strjceywcr - vsvydhcktb) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis