Drugs / Sirukumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | rheumatoid arthritis | 2017-09-22 | “Janssen Receives Complete Response Letter From U.S. FDA For Sirukumab Biologics License Application” jnj.com ↗ |
| Filed | US (FDA) | — | rheumatoid arthritis | 2016-09-23 | “Regulatory applications for approval were also submitted to the FDA for sirukumab in rheumatoid arthritis” jnj.com ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02079545 | Mar 2014 → Jan 2015 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01636557 | Oct 2012 → Oct 2013 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00844909 | Jan → Aug 2009 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01702740 | Mar 2007 → Oct 2009 | cutaneous lupus erythematosus, systemic lupus erythematosus | Centocor Research & Development, Inc. | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT04380961 | Apr 2020 → Apr 2021 | COVID-19 | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 2 | NCT02794519 | Sep → Oct 2016 | asthma | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02473289 | Jul 2015 → May 2018 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01273389 | Aug 2011 → Sep 2013 | lupus nephritis | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT00718718 | Aug 2008 → Mar 2011 | rheumatoid arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT02899026 | Mar 2018 → Aug 2020 | polymyalgia rheumatica | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT02531633 | Oct 2015 → Mar 2018 | temporal arteritis | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT02019472 | Apr 2014 → Aug 2016 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Mixed |
| Phase 3 | NCT01856309 | Aug 2013 → Apr 2018 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01689532 | Nov 2012 → Mar 2015 | rheumatoid arthritis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT01604343 | Aug 2012 → Sep 2015 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01606761 | Aug 2012 → Mar 2015 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2017-09-22 | Janssen Research & Development, LLC | Regulatory Janssen Receives Complete Response Letter From U.S. FDA For Sirukumab Biologics License Application jnj.com ↗
The complete response letter indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA. |
| 2017-06-14 | Janssen Research & Development, LLC | Results JANSSEN PRESENTS LONG TERM PHASE 3 EFFICACY AND SAFETY DATA OF SIRUKUMAB IN RHEUMATOID ARTHRITIS PATIENTS WHO HAD AN INADEQUATE RESPONSE AND/OR WHO WERE INTOLERANT TO ANTI-TNFs jnj.com ↗
JANSSEN PRESENTS LONG TERM PHASE 3 EFFICACY AND SAFETY DATA OF SIRUKUMAB IN RHEUMATOID ARTHRITIS PATIENTS WHO HAD AN INADEQUATE RESPONSE AND/OR WHO WERE INTOLERANT TO ANTI-TNFs |
| 2016-11-16 | GlaxoSmithKline | Results GSK announces new data from phase III studies of sirukumab in adult patients with moderately to severely active rheumatoid arthritis gsk.com ↗
The first study (SIRROUND-T), in patients who were refractory to or intolerant to one or more anti-tumor necrosis factor (TNF) agents, demonstrated that sirukumab met the primary endpoint showing significant improvement in the signs and symptoms of moderately to severely active RA compared to placebo. |
| 2016-09-23 | GlaxoSmithKline | Regulatory GSK announces US regulatory submission for sirukumab in rheumatoid arthritis gsk.com ↗
This US submission follows one made for Europe earlier this month and we look forward to the outcome of the regulatory authority reviews. |
| 2016-09-12 | GlaxoSmithKline | Regulatory GSK announces EU regulatory submission for sirukumab in rheumatoid arthritis gsk.com ↗
today announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) |
| 2016-06-08 | Janssen Research & Development, LLC | Results New Janssen Phase 3 Data In Patients With Moderately To Severely Active Rheumatoid Arthritis Shows Sirukumab Significantly Inhibited Radiographic Progression And Improved Signs And Symptoms Of Disease jnj.com ↗ |
| 2016-06-08 | GlaxoSmithKline | Results GSK announces phase III study of sirukumab meets both co-primary endpoints in patients with rheumatoid arthritis gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that a pivotal global phase III study investigating subcutaneous sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, in adult patients with moderately to severely active rheumatoid arthritis (RA) met both co-primary end points. |
| 2015-12-16 | GlaxoSmithKline | Results GSK receives positive top-line results from sirukumab phase III programme supporting regulatory filings for rheumatoid arthritis in 2016 gsk.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sirukumab | “A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis” NCT01636557 ↗12“Treatment With Sirukumab (CNTO 136)” PMID 27110697 ↗ Sep 2016 |
| Known as | CNTO 136 | “A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy...” NCT01606761 ↗8“A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)” NCT01604343 ↗ “A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis” NCT01636557 ↗ “A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine” NCT01689532 ↗ “This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two groups of participants at the same time (parallel-group study).” NCT01856309 ↗ “Treatment With Sirukumab (CNTO 136)” PMID 27110697 ↗ Sep 2016 |
| Action | Inhibit | “anti-interleukin-6 monoclonal antibody” PMID 27110697 ↗ Sep 2016 |
| Modality | Monoclonal antibody | “sirukumab, an anti-interleukin-6 monoclonal antibody” PMID 27110697 ↗ Sep 2016 |
| Route | Subcutaneous | “CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.” NCT00718718 ↗ |
| Target | IL6 | “anti-interleukin-6 monoclonal antibody” PMID 27110697 ↗ Sep 2016 |