Drugs / Clazakizumab
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03380962 | Feb 2018 → Aug 2025 overdue | chronic renal failure syndrome, chronic transplant rejection, disease related to solid organ transplantation, end stage renal failure | Stanley Jordan, MD | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03380377 | Feb 2018 → Apr 2024 | chronic transplant rejection, disease related to solid organ transplantation, glomerular disorder | Stanley Jordan, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT01530256 | Mar 2012 → Mar 2013 | acute graft versus host disease | CSL Behring | Terminated | No outcome recorded |
| Phase 213 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT07783802 | Aug 2026 → May 2027 expected | atherosclerosis, chronic kidney disease, hypertensive disorder, obesity disorder +1 | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT05727384 | Aug 2023 → Jan 2026 | — | Anne B. Newman | Completed | No outcome recorded |
| Phase 2 | NCT04494724 | Jul → Dec 2020 overdue | COVID-19 | The Methodist Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04381052 | May 2020 → Apr 2021 | COVID-19 | Columbia University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04343989 | Mar 2020 → Feb 2021 | COVID-19 | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT04129931 | Dec 2019 → Feb 2025 | asthma | University of North Carolina, Chapel Hill | Completed | Missed primary |
| Phase 2 | NCT01545050 | Jun 2012 → Dec 2013 | Crohn disease | CSL Behring | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02015520 | Jun 2012 → Jun 2013 | rheumatoid arthritis | CSL Behring | Completed | Met primary |
| Phase 2 | NCT01490450 | Dec 2011 → Jun 2013 | psoriatic arthritis | CSL Behring | Completed | Met primary |
| Phase 2 | NCT01403064 | Jul 2011 → Apr 2013 | mucositis | CSL Behring | Terminated | No outcome recorded |
| Phase 2 | NCT01373151 | Jun 2011 → Sep 2012 | rheumatoid arthritis | CSL Behring | Completed | Met primary |
| Phase 2 | NCT00867516 | Oct 2008 → Jun 2009 | rheumatoid arthritis | CSL Behring | Completed | No outcome recorded |
| Phase 2 | NCT00866970 | Sep 2008 → Aug 2009 | non-small cell lung carcinoma | CSL Behring | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT04348500 Comparator | Apr → Sep 2020 | COVID-19 | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03444103 Comparator | Jan 2018 → Jun 2020 | transplant rejection | Medical University of Vienna | Completed | No outcome recorded |
| Phase 3 | NCT03744910 Comparator | Oct 2019 → Apr 2024 | transplant rejection | CSL Behring | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2013-10-28 | Bristol-Myers Squibb | Results Promising Phase IIb Data On Clazakizumab In Patients With Moderate-To-Severe Rheumatoid Arthritis To Be Presented At The 2013 Annual Meeting Of The American College Of Rheumatology bms.com ↗
All clazakizumab treatment arms, alone or in combination with MTX, demonstrated efficacy in controlling the signs and symptoms of RA, and met the predefined primary endpoint of a higher ACR20 response rate vs. MTX alone after 12 weeks of treatment. |
| 2010-06-15 | Bristol-Myers Squibb | Results New Data for Investigational Antibody Blocking IL-6 in Rheumatoid Arthritis Patients to be Presented at Annual Congress of European League Against Rheumatism bms.com ↗
All three treatment groups met the primary endpoint of statistically significant improvements in the ACR20 score over placebo at Week 12. |
All press releases naming this drug 2 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clazakizumab | “efficacy of clazakizumab, a monoclonal antibody” PMID 27059799 ↗ Sep 2016 |
| Known as | ALD518 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01530256 ↗ |
| Known as | BMS-945429 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01373151 ↗ |
| Action | Inhibit | “IL-6 blockade” PMID 27059799 ↗ Sep 2016 |
| Modality | Monoclonal antibody | “a monoclonal antibody with high affinity and specificity for the interleukin-6 (IL-6) cytokine” PMID 27059799 ↗ Sep 2016 |
| Route | Intravenous | “ALD518 160 mg IV on Day 1, Week 8 and Week 16” NCT00866970 ↗ |
| Target | IL6 | “clazakizumab (anti-IL6 monoclonal antibody)” NCT03380377 ↗ |