Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 538 |
| INN | Clazakizumab |
| Status | Clinical |
| Drug code(s) | CSL300, ALD518; BMS-945429 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rabbit B cell derived |
| Target(s) | IL-6 |
| Indications of clinical studies | Subjects With End Stage Kidney Disease Undergoing Dialysis, COVID-19, Acute GvHD, Psoriatic arthritis; Crohn's disease, Rheumatoid arthritis, Oral Mucositis, Non-Small Cell Lung Cancer-Related Fatigue and cachexia |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2008 |
| Start of Phase 2 | March 15, 2009 |
| Start of Phase 3 | May 15, 2019 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | H. Lundbeck A/S |
| Licensee/Partner | CSL Behring |
| Comments about company or candidate | NCT05485961 Phase 2/3 still recruiting as of last update in Nov 2024. Apr 2024: NCT03744910 Phase 3 terminated (Early stop for lack of efficacy/futility (at Interim analysis)) Phase 3 study Antibody-mediated rejection in kidney transplant recipients (NCT03744910) and phase 2/3 study for Atherosclerotic Cardiovascular Disease, End-stage kidney disease (NCT05485961) are recruiting as of April 2023. CSL Behring press release November 2022: "Clazakizumab 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. Vitaeris Bio in collaboration with Imperial College London registered a Phase II, study to assess the safety and efficacy of Clazakizumab in patients with COVID-19 and kidney disease. The trial was registered with the European clinical trial registry. June 20, 2020, CSL Behring announced that it has agreed to acquire Vitaeris Inc. The companies entered into a strategic partnership in 2017 to expedite the development of clazakizumab with the option for CSL Behring to acquire Vitaeris, along with this important product candidate. With this acquisition, clazakizumab joins CSL842 and CSL964 as part of CSL Behring’s portfolio of products in late-stage development to address significant unmet needs in the transplant community. NCT04381052 Phase 2 study in COVID-19 due to start in May 2020. Oct 2019: H. Lundbeck announced that it has completed the acquisition of Alder BioPharmaceuticals. EudraCT 2018-003682-34 Phase 3 started in ~mid-May 2019. NCT03744910 Phase 3 study to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients started recruiting June 10, 2019. In December 2017, CSL and Vitaeris announced that they have entered into a strategic collaboration and purchase option agreement to expedite the development of clazakizumab. Licensed to Vitaeris (Vancouver BC) in early 2016. Rheumatoid arthritis Phase 2 study endpoint met as announced in Oct 2013. NCT02015520 Phase 2 study recruiting as of May 2014 |
| Full address of company | Ottiliavej 9, 2500 Valby, Denmark Europe Denmark https://www.lundbeck.com/global |
Proprietary yeast expression system. Aglycosylated (N297A mutation) and produced in P. pastoris.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |