Drugs / gevokizumab
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03798626 | May 2019 → Mar 2023 | colorectal cancer, gastroesophageal cancer, renal cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01211977 | Aug 2010 → Apr 2011 | Behcet disease, Muckle-Wells syndrome | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Withdrawn | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05178576 | Jun 2022 → Feb 2026 | colon carcinoma | NSABP Foundation Inc | Withdrawn | No outcome recorded |
| Phase 2 | NCT01950312 | Aug 2013 → Oct 2015 | autoimmune inner ear disease | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01882504 | May 2013 → Oct 2015 | pyoderma gangrenosum | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01882491 | May 2013 → Feb 2014 | osteoarthritis | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01683396 | Jul 2012 → Feb 2014 | osteoarthritis | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01498874 | Dec 2011 → Apr 2013 | acne | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01066715 | Jan 2010 → Jul 2011 | type 2 diabetes mellitus | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 39 trials · 1 missed | ||||||
| Phase 3 | NCT02326740 | Dec 2014 → Mar 2016 | pyoderma gangrenosum | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02318914 | Nov 2014 → Feb 2016 | pyoderma gangrenosum | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02258867 | Nov 2014 → Oct 2015 | uveitis | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02315417 | Nov 2014 → Mar 2016 | pyoderma gangrenosum | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02375685 | Aug 2014 → Nov 2015 | uveitis | Servier | Terminated | No outcome recorded |
| Phase 3 | NCT02258854 | Mar 2014 → Oct 2017 | uveitis | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01965145 | Nov 2012 → Jul 2015 | Behcet disease | Servier | Terminated | Missed primary |
| Phase 3 | NCT01747538 | Oct 2012 → Jun 2016 | uveitis | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01684345 | Aug 2012 → Feb 2016 | uveitis | XOMA (US) LLC | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02293564 | Mar 2013 → Jan 2015 | osteoarthritis | XOMA (US) LLC | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT00541983 Comparator | Sep 2007 → Jul 2009 | type 2 diabetes mellitus | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT00513214 Comparator | Jul 2007 → Jun 2009 | type 2 diabetes mellitus | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01144975 Comparator | May 2010 → Oct 2011 | type 2 diabetes mellitus | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT00998699 Comparator | Feb 2010 → Aug 2013 | type 1 diabetes mellitus | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2 | NCT01788033 Comparator | Sep 2009 → Sep 2013 | type 1 diabetes mellitus | University of Zurich | Completed | No outcome recorded |
| Phase 2 | NCT00777816 Comparator | Feb 2009 → Oct 2014 | rheumatoid arthritis | XOMA (US) LLC | Suspended | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2015-07-22 | XOMA (US) LLC | Results XOMA Announces Results From Phase 3 EYEGUARD(TM)-B Study xoma.com ↗
did not meet the primary endpoint of time to first acute ocular exacerbation. |
| 2014-05-07 | XOMA (US) LLC | Regulatory XOMA Reports First Quarter 2014 Operational Highlights and Financial Results xoma.com ↗
Announced gevokizumab had been granted Orphan Drug Designation by the FDA for the treatment of PG. |
| 2014-03-04 | XOMA (US) LLC | Results XOMA Reports 2013 Operational Highlights and Fourth Quarter and Full-Year 2013 Financial Results xoma.com ↗ |
| 2014-03-04 | XOMA (US) LLC | Results XOMA Provides Update on Gevokizumab Proof-of-Concept Program xoma.com ↗
Based on results from the Company's Phase 2 program in patients with erosive osteoarthritis of the hand (EOA), XOMA does not intend to launch pivotal development for the broad EOA indication. |
| 2014-02-24 | XOMA (US) LLC | Regulatory XOMA Receives Orphan Drug Designation From U.S. FDA for Pyoderma Gangrenosum xoma.com ↗
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today gevokizumab, the Company's IL-1 beta modulating antibody, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of pyoderma gangrenosum (PG). |
| 2013-10-30 | XOMA (US) LLC | Results Results From Two Phase 2 Studies in XOMA's Gevokizumab Proof-of-Concept Program Are Very Encouraging and Compelling xoma.com ↗
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced very encouraging results from two Phase 2 clinical studies that are part of the Company's broad gevokizumab proof-of-concept ("POC") program. |
| 2013-01-07 | XOMA (US) LLC | Results XOMA Announces Encouraging Interim Results From Gevokizumab Phase 2 Study for Moderate to Severe Acne Vulgaris xoma.com ↗
The 0.6mg/kg dose group showed a statistically significant reduction of 19 in mean inflammatory lesion count on Day 42 compared to a reduction of 13 in the placebo treated group (p=0.077). |
| 2012-08-22 | XOMA (US) LLC | Regulatory XOMA Receives Orphan Drug Designation From U.S. Food & Drug Administration for Gevokizumab xoma.com ↗
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that gevokizumab, the company's IL-1 beta modulating antibody, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis. |
| 2011-06-08 | XOMA (US) LLC | Results XOMA Announces Phase 2a Six-Month Top Line Trial Results Support Safety and Biological Activity xoma.com ↗
XOMA 052 continued to show evidence of biological activity as shown by a reduction in levels of C-reactive protein, a biomarker of cardiovascular risk. |
| 2011-03-22 | XOMA (US) LLC | Results XOMA 052 Phase 2b Top Line Results: Glucose Control Not Demonstrated, Positive Anti-inflammatory Effect, Cardiovascular Biomarker and Lipid Improvement and Safety Confirmed xoma.com ↗
In addition, statistically significant (p<0.05) improvements in high-density lipoprotein, or "good" cholesterol were observed in two of four XOMA 052 dose groups versus placebo. |
| 2011-01-06 | XOMA (US) LLC | Results Interim Three Month Data From Ongoing Six Month XOMA 052 Phase 2a Trial Support Safety and Biological Activity xoma.com ↗
At the time of this three month interim review, evidence of biological activity was observed, including a reduction in C-reactive protein levels and a modest reduction in hemoglobin A1c levels. |
| 2010-11-10 | XOMA (US) LLC | Results Positive XOMA 052 Results in Inflammatory Eye Disease - Behcet's Uveitis - Presented at American College of Rheumatology Scientific Meeting xoma.com ↗
The new results demonstrated that each of the five patients re-treated with XOMA 052 due to a recurring uveitis exacerbation responded again to XOMA 052 treatment and maintained their response for several months. |
| 2010-08-04 | XOMA (US) LLC | Regulatory XOMA 052 Designated Orphan Drug by FDA for Treatment of Behcet's Disease xoma.com ↗
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the U.S. Food and Drug Administration has designated XOMA 052, an antibody to interleukin-1 beta, an orphan drug for the treatment of Behcet's disease. |
| 2010-07-29 | XOMA (US) LLC | Regulatory XOMA 052 Orphan Drug Designation for Behcet's Disease Recommended by European Medicines Agency xoma.com ↗ |
| 2010-06-26 | XOMA (US) LLC | Results Preclinical Results With XOMA 052 in Type 2 Diabetes Presented at American Diabetes Association 70th Scientific Sessions xoma.com ↗
The results also demonstrated no deleterious effects with the two-drug combinations and improved insulin tolerance with a combination of XOMA 052 and sitagliptin. |
| 2010-06-22 | XOMA (US) LLC | Results Journal Article in Endocrinology Highlights Preclinical XOMA 052 Data in Type 2 Diabetes xoma.com ↗
The mice treated with XOMA 052 demonstrated reduced levels of lipids compared to the control. |
| 2010-06-17 | XOMA (US) LLC | Results Positive Clinical Findings Presented on XOMA 052 in Debilitating Eye Disease xoma.com ↗
The preliminary results of the first clinical trial of XOMA 052 in patients with uveitis of Behcet's disease were presented today at the Annual Congress of the European League against Rheumatism (EULAR) in Rome, Italy. |
| 2010-05-12 | XOMA (US) LLC | Results Abstract Published on Initial Results From XOMA 052 Clinical Trial in Behcet's Disease xoma.com ↗
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the publication of an abstract titled, "Safe, Rapid-onset and Sustained Biological Activity of IL-1 beta Regulating Antibody XOMA 052 in Resistant Uveitis of Behcet's Disease: Preliminary Results of a Pilot Trial." |
| 2010-04-30 | XOMA (US) LLC | Results XOMA 052 Mechanism of Action Results Published in Journal of Biological Chemistry xoma.com ↗
By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation. |
| 2010-04-19 | XOMA (US) LLC | Results XOMA 052 Shows Potent In Vitro Inhibition of Interleukin-6 Production in Human Myeloma Cells xoma.com ↗
The reduction with XOMA 052 was greater than 90% in samples from the patients with the highest levels of IL-6 production. |
| 2010-03-14 | XOMA (US) LLC | Results XOMA 052 Prevents Adverse Cardiac Remodeling in Animal Model of Heart Attack xoma.com ↗
Treatment with the two higher doses of XOMA 052 resulted in statistically significant improvements in measurements of left ventricular cardiac function including the ability to pump blood, which is related to an individual's chance of developing congestive heart failure. |
| 2009-10-20 | XOMA (US) LLC | Results XOMA Presents First XOMA 052 Cardiovascular Disease Animal Model Results xoma.com ↗
The results demonstrated that mice treated with a murine equivalent of XOMA 052 had a statistically significant reduction in the formation of atherosclerotic lesions |
| 2009-09-30 | XOMA (US) LLC | Results XOMA Presents Results Demonstrating Novel Mechanism of Action for XOMA 052 in Regulating IL-1 Beta Levels xoma.com ↗
XOMA 052 acts by reducing the affinity of IL-1 beta for its signaling receptor, while having no effect on the decoy receptors that clear excess IL-1 beta from the body. |
| 2009-07-14 | XOMA (US) LLC | Results XOMA Announces Positive Results From U.S. Phase 1 Trial of XOMA 052 in Type 2 Diabetes xoma.com ↗
The results continue to demonstrate that XOMA 052 is well tolerated in patients. |
| 2009-06-08 | XOMA (US) LLC | Results XOMA Presents Data At ADA Demonstrating Improvement in Diabetes and Inflammatory Measures in Animal Model With XOMA 052 xoma.com ↗
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the presentation of new preclinical results with XOMA 052 in the diet-induced obesity mouse model. |
| 2009-06-06 | XOMA (US) LLC | Results XOMA 052 Clinical Results Support Novel Anti-Inflammatory Approach to Type 2 Diabetes Treatment xoma.com ↗
XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced new results which included additional data for up to three months and new measures of biological activity from Phase 1 clinical trials of a single dose of XOMA 052 given intravenously to patients with Type 2 diabetes. |
| 2009-05-26 | XOMA (US) LLC | Results XOMA Announces Clinical and Preclinical Presentations At American Diabetes Association 69th Scientific Sessions xoma.com ↗
XOMA 052, a potential disease modifying anti IL-1-beta antibody, shows sustained HbA1c reductions three months after a single injection with no increase in safety parameters in subjects with Type 2 diabetes. |
| 2008-10-25 | XOMA (US) LLC | Results XOMA Presents Data On XOMA 052, An Anti-IL-1 Beta Antibody, in Rheumatoid Arthritis and Acute Gout Animal Models xoma.com ↗
The poster also contains data demonstrating that XOMA 052 blocks inflammation in a mouse model of acute gout. |
| 2008-09-08 | XOMA (US) LLC | Results XOMA 052 Clinical Results Support New Type 2 Diabetes Therapeutic Approach of Targeting Inflammatory Damage to Insulin-Producing Cells xoma.com ↗
XOMA Ltd. (Nasdaq:XOMA) announced interim data from two Phase 1 clinical studies of XOMA 052, an antibody drug candidate with an ultra high binding affinity of 300 femtomolar, which support a novel anti-inflammatory approach to Type 2 diabetes treatment that may preserve insulin-producing cells. |
| 2008-07-15 | XOMA (US) LLC | Results XOMA 052 Phase 1 Data to be Presented At European Association for the Study of Diabetes Annual Meeting xoma.com ↗
In the two studies, XOMA 052 was well tolerated without any evidence of serious drug-related adverse events. |
| 2008-06-07 | XOMA (US) LLC | Results XOMA 052 Demonstrates Anti-Inflammatory Effects in Diabetes Animal Studies; Data Presented At ADA xoma.com ↗
The animal data indicate that XOMA 052 may be the first disease-modifying anti-diabetic therapy with the potential to improve glycemic control and address the risk of cardiovascular events, |
| 2008-06-07 | XOMA (US) LLC | Results XOMA 052 Demonstrates Anti-Inflammatory Effect in Arthritis Animal Studies; Data Presented At FOCIS xoma.com ↗
XOMA 052 administered therapeutically following disease onset lowered the mean disease score, demonstrating clinically relevant therapeutic intervention. |
All press releases naming this drug 66 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gevokizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02258867 ↗ |
| Known as | VPM-087 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743026 ↗ |
| Known as | XOMA 052 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00513214 ↗ |
| Action | Inhibit | “This novel IL-1β-neutralizing antibody improved glycemia, possibly via restored insulin production and action, and reduced inflammation in patients with type 2 diabetes.” PMID 22699287 ↗ Jun 20121“Interleukin-1 beta negative allosteric modulator” CHEMBL1743026 ↗ |
| Modality | Monoclonal antibody | “Gevokizumab is a novel, human-engineered monoclonal anti-IL-1β antibody.” PMID 22699287 ↗ Jun 2012 |
| Route | Intravenous | “Single IV infusion” NCT00513214 ↗ |
| Target | IL1B | “Interleukin-1 beta negative allosteric modulator” CHEMBL1743026 ↗ |