Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 43 |
| INN | Olokizumab |
| Status | Approved |
| Drug code(s) | CDP-6038 |
| Brand name | ARTLEGIA |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rat B cell derived |
| Target(s) | IL-6 |
| Indications of clinical studies | COVID-19, Crohn's Disease, Rheumatoid Arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2008 |
| Start of Phase 2 | November 15, 2010 |
| Start of Phase 3 | May 15, 2016 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2020 |
| Date of first US approval | |
| INN, US product name | Olokizumab |
| US or EU approved indications | None |
| Company | UCB |
| Licensee/Partner | R-Pharm |
| Comments about company or candidate | May 29, 2020: R-Pharm Group of Companies successfully registered Artlegia (olokizumab), a novel drug for treatment of rheumatoid arthritis in the first country - Russia. The drug is manufactured at the R-Pharm Yaroslavl Plant of Finished Dosage Forms, and has already been sent to a number of Russian health centers. http://r-pharm.com/en/press-center/news/467 NCT04380519 Phase 2/3 study in COVID-19. April 28, 2020: R-Pharm JSC and Cromos Pharma announced that it has randomized the first patients into a clinical trial evaluating Olokizumab and RPH-104 in patients with severe COVID-19 infection. R-Pharma completes a phase III trial for Rheumatoid arthritis (Combination therapy) in Bulgaria and Russia (SC) (NCT02760368); 3 other Phase 3 studies recruiting as of Aug 2019. Four Phase 3 studies in RA recruiting as of July 2018; NCT03120949 Phase 3 study started in July 2017. Three phase III studies (NCT02760433, NCT02760368, NCT02760407) commenced in May 2016, but suspended in July 2016. Restarted recruitment in December 2016. Launch of the phase 3 program – CREDO (Clinical Rheumatoid Arthritis Development for Olokizumab announced in Dec 2015. Terminated in Q3 2012. Topline results for the drug involving 220 patients who had previously failed on anti-TNF treatments showed little difference between it and Actemra, the current incumbent in this hard-to-treat space. Without any superiority benefits over a drug that is heading towards blockbuster status and the FDA’s increasingly toughening stance on ‘me too’ products UCB would have struggled to carve out any significant sales on its own. Licensed to R-Pharma in July 2013. Under the terms of this agreement, R-Pharm will develop, register, manufacture, distribute and book sales globally. UCB receives an upfront payment and is entitled to receive payments on development and commercialization milestones and royalties. Terminated by UCB at Phase 2, but licensed to R-Pharma in July 2013 |
| Full address of company | Allée de la Recherche, 60 1070 Brussels Belgium Europe Belgium https://www.ucb.com/contact |
Humanized rat-derived antibody. MAbs. 2014 May 1; 6(3): 773–781. S228P mutation for stability
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |