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6 Diseases |  |
1 Trial |
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1 Trial |  |
40 News |  |
- | Journal: Costimulation blockade: the next generation. (Pubmed Central) - Jan 30, 2025
Investigational agents with subcutaneous delivery methods could overcome logistical challenges, improve adherence, and redefine posttransplant care. These advancements in costimulation blockade may enhance long-term graft survival and transform the management of KT recipients.
- ||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment change: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Oct 8, 2024
P1/2, N=24, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
These advancements in costimulation blockade may enhance long-term graft survival and transform the management of KT recipients. N=10 --> 24
- | Retrospective data, Journal: Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus. (Pubmed Central) - Dec 5, 2023
The final MBMA model was then used to benchmark these compounds with respect to the maximal efficacy on the latent variable compared to the placebo. This MBMA illustrates the application of latent variable models in understanding the trajectories of composite end points in chronic diseases and should enable model-informed development of new investigational agents in SLE.
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial completion: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Oct 6, 2023
P1/2, N=10, Completed, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This MBMA illustrates the application of latent variable models in understanding the trajectories of composite end points in chronic diseases and should enable model-informed development of new investigational agents in SLE. Active, not recruiting --> Completed
- | lulizumab pegol (BMS-931699) / BMS
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Selective CD28 Blockade in Renal Transplant Recipients (clinicaltrials.gov) - Mar 22, 2023
P2, N=0, Withdrawn, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed N=54 --> 0 | Trial completion date: Oct 2024 --> Sep 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2023 --> Sep 2022
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial completion date, Trial primary completion date: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Feb 13, 2023
P1/2, N=10, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=54 --> 0 | Trial completion date: Oct 2024 --> Sep 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2023 --> Sep 2022 Trial completion date: Apr 2024 --> Aug 2023 | Trial primary completion date: Apr 2024 --> Aug 2023
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial primary completion date: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Nov 2, 2022
P1/2, N=10, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial completion date: Apr 2024 --> Aug 2023 | Trial primary completion date: Apr 2024 --> Aug 2023 Trial primary completion date: Sep 2022 --> Apr 2024
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment closed, Trial completion date, Trial primary completion date: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - May 5, 2022
P1/2, N=10, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial primary completion date: Sep 2022 --> Apr 2024 Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Apr 2024 | Trial primary completion date: Jun 2022 --> Sep 2022
- | lulizumab pegol (BMS-931699) / BMS
Preclinical, Journal: Preoperative Carfilzomib and Lulizumab based desensitization prolongs graft survival in a sensitized non-human primate model. (Pubmed Central) - Jun 22, 2021
Desensitization with CFZ and Lulizumab improves allograft survival in allosensitized NHPs, by transient control of the germinal center and shifting of the immune system to a more naive phenotype. This regimen may translate into clinical practice to improve outcomes of highly sensitized transplant patients.
- |||| lulizumab pegol (BMS-931699) / BMS
New P2 trial: Selective CD28 Blockade in Renal Transplant Recipients (clinicaltrials.gov) - May 26, 2021
P2, N=54, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- tacrolimus / Generic mfg., Kyprolis (carfilzomib) / Amgen, Ono Pharma, lulizumab pegol (BMS-931699) / BMS
[VIRTUAL] Carfilzomib and lulizumab-based desensitization prolongs allograft survival in sensitized non-human primates kidney transplantation model (Channel 8) - Aug 29, 2020 - Abstract #TTS2020TTS_501;
We previously reported the benefit of desensitization using carfilzomib and belatacept in a non-human primate (NHP) model. Here we evaluated a desensitization strategy combining carfilzomib (CFZ) with lulizumab (CD28dAb) which, conceptually, has greater immunoregulatory benefit over belatacept by selectively blocking the co-stimulating signal (CD28-B7) whilst preserving the co-inhibitory signal (CTLA4-B7)...All primates received induction therapy with rhesus-specific antithymocyte globulin and maintenance immunosuppression with tacrolimus, mycophenolate, and methylprednisolone... Desensitization with CFZ and CD28dAb significantly prolongs allograft survival in allosensitized NHPs by reducing DSA and the germinal center response, likely by promoting a more naive lymphocyte repertoire and increasing the frequency of Tregs. Despite this, the strategy failed to promote durable desensitization, suggesting the need for continuous control of the humoral immune response post-transplantation.
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Trial primary completion date: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Jul 16, 2020
P1/2, N=10, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Despite this, the strategy failed to promote durable desensitization, suggesting the need for continuous control of the humoral immune response post-transplantation. Trial primary completion date: Apr 2021 --> Jun 2022
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment open: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Dec 12, 2019
P1/2, N=10, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Trial primary completion date: Apr 2021 --> Jun 2022 Not yet recruiting --> Recruiting
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
New P1/2 trial: Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) - Aug 26, 2019
P1/2, N=10, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- |||| lulizumab pegol (BMS-931699) / BMS
Trial completion, Enrollment change: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Jan 4, 2019
P2, N=730, Completed, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Recruiting Terminated --> Completed | N=350 --> 730
- | BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Enrollment change: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Oct 4, 2018
P2, N=45, Terminated, Sponsor: Bristol-Myers Squibb
Terminated --> Completed | N=350 --> 730 N=80 --> 45
- lulizumab pegol (BMS-931699) / BMS
Enrollment change, Trial termination: Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial (clinicaltrials.gov) - Dec 20, 2017
P1, N=5, Terminated, Sponsor: Bristol-Myers Squibb
N=80 --> 45 N=60 --> 5 | Not yet recruiting --> Terminated; Business objectives have changed
- | lulizumab pegol (BMS-931699) / BMS
Trial termination, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Dec 2, 2017
P2, N=350, Terminated, Sponsor: Bristol-Myers Squibb
N=60 --> 5 | Not yet recruiting --> Terminated; Business objectives have changed Active, not recruiting --> Terminated
- BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Enrollment change, Trial primary completion date: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Jul 28, 2017
P2, N=80, Terminated, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Terminated N=18 --> 80 | Trial primary completion date: Sep 2018 --> Jul 2017
- BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Enrollment change: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Jun 27, 2017
P2, N=18, Terminated, Sponsor: Bristol-Myers Squibb
N=18 --> 80 | Trial primary completion date: Sep 2018 --> Jul 2017 N=80 --> 18
- | BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Trial termination: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Jun 15, 2017
P2, N=80, Terminated, Sponsor: Bristol-Myers Squibb
N=80 --> 18 Recruiting --> Terminated; Inability to meet protocol objectives
- || lulizumab pegol (BMS-931699) / BMS
Trial primary completion date, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - May 18, 2017
P2, N=350, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Recruiting --> Terminated; Inability to meet protocol objectives Trial primary completion date: Apr 2017 --> Jul 2017
- ||| lulizumab pegol (BMS-931699) / BMS
Enrollment closed, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Mar 31, 2017
P2, N=350, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Apr 2017 --> Jul 2017 Recruiting --> Active, not recruiting
- ||| lulizumab pegol (BMS-931699) / BMS
New P1 trial: Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial (clinicaltrials.gov) - Feb 23, 2017
P1, N=60, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- |||| BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Enrollment open, Enrollment change: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Oct 28, 2016
P2, N=80, Recruiting, Sponsor: Bristol-Myers Squibb
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | N=120 --> 80
- || BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Trial primary completion date: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Sep 26, 2016
P2, N=120, Not yet recruiting, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Recruiting | N=120 --> 80 Trial primary completion date: Apr 2018 --> Sep 2018
- || BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
Trial primary completion date: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Aug 24, 2016
P2, N=120, Not yet recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Apr 2018 --> Sep 2018 Trial primary completion date: Jul 2018 --> Apr 2018
- ||||| BMS-986142 / BMS, lulizumab pegol (BMS-931699) / BMS
New P2 trial: Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sj (clinicaltrials.gov) - Jul 27, 2016
P2, N=120, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- lulizumab pegol (BMS-931699) / BMS
Trial primary completion date, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 8, 2015
P2, N=350, Recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Jul 2018 --> Apr 2018 Trial primary completion date: Jun 2017 --> Mar 2017
- || lulizumab pegol (BMS-931699) / BMS
Trial primary completion date, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Jun 11, 2015
P2, N=350, Recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Jun 2017 --> Mar 2017 Trial primary completion date: Mar 2017 --> Jun 2017
- || lulizumab pegol (BMS-931699) / BMS
Trial primary completion date, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Dec 9, 2014
P2, N=350, Recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Mar 2017 --> Jun 2017 Trial primary completion date: Apr 2018 --> Mar 2017
- |||| lulizumab pegol (BMS-931699) / BMS
Enrollment open, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 23, 2014
P2, N=350, Recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Apr 2018 --> Mar 2017 Not yet recruiting --> Recruiting
- || lulizumab pegol (BMS-931699) / BMS
Trial primary completion date, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 15, 2014
P2, N=350, Not yet recruiting, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2017 --> Apr 2018
- ||||| lulizumab pegol (BMS-931699) / BMS
New P2 trial, IO biomarker: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus (clinicaltrials.gov) - Oct 17, 2014
P2, N=350, Not yet recruiting, Sponsor: Bristol-Myers Squibb