Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1994 |
| INN | Sirukumab |
| Status | Terminated |
| Drug code(s) | CNTO 136 |
| 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 | None |
| Target(s) | IL-6 |
| Indications of clinical studies | COVID-19, Polymyalgia Rheumatica, Giant Cell Arteritis, Depressive disorder, Lupus Nephritis, Kidney Diseases, Kidney Insufficiency, Glomerulonephritis, Systemic Lupus Erythematosus, Rheumatoid arthritis, asthma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at regulatory review |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2009 |
| Start of Phase 2 | August 15, 2011 |
| Start of Phase 3 | August 15, 2012 |
| 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 | Janssen Research & Development LLC |
| Licensee/Partner | GlaxoSmithKline |
| Comments about company or candidate | NCT04380961 Phase 2 in COVID-19 started in April 2020 completed in June 2021. NCT02473289 Phase 2 study in depressive disorder completed in May 2018. Oct 2017: J&J has made a decision not to pursue global approvals of sirukumab for the treatment of moderately to severely active rheumatoid arthritis; Phase 3 study in Giant Cell Arteritis terminated, Phase 3 study in Polymyalgia Rheumatica withdrawn. NCT02899026 Phase 3 study in Polymyalgia Rheumatica Withdrawn (GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in polymyalgia rheumatica.) Sep 2017: Janssen Biotech has received a Complete Response Letter (CRL) from the FDA in response to its Biologics License Application (BLA) seeking approval for sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). The CRL cited the need for additional clinical data to assess the drug's safety. Aug 2017: FDA's Arthritis Advisory Committee (AAC) voted 12-1 against approval of sirukumab (CNTO 136) from Johnson & Johnson to treat moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The committee based its decision on the safety profile of the human IgG1 kappa mAb against IL-6. The committee voted 13-0 that J&J’s data provides “substantial evidence” of sirukumab’s efficacy, but voted 11-2 that its safety profile is not "adequate" to support approval. FDA asked committee members to discuss Phase III data which showed an imbalance in all-cause mortality between sirukumab and placebo. J&J will continue discussions with FDA for its BLA for sirukumab. Its PDUFA date is Sept. 22. An MAA for sirukumab is under EMA review. J&J expects a decision later in 2017.In July 2017, GSK announced the asset is to be terminated or divested. Announcement of MMA submission for RA was made Sep 12, 2016. Phase 3 in Giant Cell Arteritis recruiting as of Oct 2015. Recruitment in Phase 2 study in asthma suspended in November 2016. |
| Full address of company | Raritan, New Jersey, United States North America United States of America https://www.janssen.com/ |
Patent US7560112 describes the work done by AME in collaboration with Centocor and uses the term “chimeric” describing CNTO328 and “human engineered” (term used in the patent as a substitute for “humanized”) describing CNTO136. Note that the figures use “CNTO136” whereas the figure legends refer to that antibody as the “human engineered anti-IL-6 antibody”.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |