 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
- || Clinical, Retrospective data, Review, Journal: Immunotherapy as a treatment for type 1 diabetes mellitus in children and young adults: A comprehensive systematic review and meta-analysis. (Pubmed Central) - Apr 11, 2025
The main study's strength is its focus on randomized clinical trials which is considered among the highest levels of epidemiological evidence. Therefore, further research is required to minimize the gaps and to explore immunotherapy-based drugs as potential treatments for T1DM.
- | ladarixin (DF-2156A) / Dompe
Preclinical, Journal: Effects of CXCR1/2 Blockade with Ladarixin on Streptozotocin-Induced Type 1 Diabetes Mellitus and Peripheral Neuropathy and Retinopathy in Rat. (Pubmed Central) - Mar 12, 2025
Strikingly, even in the absence of an effect on glycemic control, late LDX mitigated STZ-induced mechanical allodynia and thermal hyperalgesia and vitreous (CXCL8, CitH3) and retinal (CXCL8, CXCR1/2, myeloperoxidase, CitH3) inflammatory/pro-angiogenic (vascular endothelial growth factor, CD34) signs of DR. These data confirm the efficacy of LDX in STZ-induced T1DM and provide evidence of a protective effect also against DPN and onset of DR which is independent of its effect on ?-cell functionality preservation and glycemic control.
- ||| ladarixin (DF-2156A) / Dompe
Phase classification, Enrollment change, Trial primary completion date: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Nov 7, 2024
P2, N=140, Active, not recruiting, Sponsor: Domp
These data confirm the efficacy of LDX in STZ-induced T1DM and provide evidence of a protective effect also against DPN and onset of DR which is independent of its effect on ?-cell functionality preservation and glycemic control. Phase classification: P3 --> P2 | N=327 --> 140 | Trial primary completion date: Mar 2025 --> Apr 2024
- | ladarixin (DF-2156A) / Dompe
Journal: Modulation of MMP9 and CXCR2/CXCL1/IL-8 axis in human abdominal aortic aneurysm tissues by ladarixin. (Pubmed Central) - Sep 5, 2024
Phase classification: P3 --> P2 | N=327 --> 140 | Trial primary completion date: Mar 2025 --> Apr 2024 No abstract available
- | Actemra IV (tocilizumab) / Roche, JW Pharma, ladarixin (DF-2156A) / Dompe
Journal: Tumor-secreted extracellular vesicles counteract therapy response by triggering inflammatory mesenchymal stem cell development. (Pubmed Central) - Aug 8, 2024
No abstract available Our observations establish iMSCs as major contributors to drug resistance, reveal EVs as physiological triggers of iMSC development and highlight a promising combination strategy to improve therapy response in bone cancer patients.
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
Phase classification, Metastases: Ladarixin With Sotorasib in Advanced NSCLC (clinicaltrials.gov) - Mar 28, 2024
P1, N=40, Recruiting, Sponsor: NYU Langone Health
Our observations establish iMSCs as major contributors to drug resistance, reveal EVs as physiological triggers of iMSC development and highlight a promising combination strategy to improve therapy response in bone cancer patients. Phase classification: P1/2 --> P1
- ||||| ladarixin (DF-2156A) / Dompe
Enrollment closed: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Mar 22, 2024
P3, N=327, Active, not recruiting, Sponsor: Domp
Phase classification: P1/2 --> P1 Recruiting --> Active, not recruiting
- ||| ladarixin (DF-2156A) / Dompe
Trial completion date, Trial termination, Trial primary completion date: A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved (clinicaltrials.gov) - Nov 13, 2023
P2, N=25, Terminated, Sponsor: Domp
Recruiting --> Active, not recruiting Trial completion date: Apr 2024 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Apr 2023; low recruitment rate
- | ladarixin (DF-2156A) / Dompe
Enrollment change, Trial termination: CONSERVA: Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes. (clinicaltrials.gov) - Nov 7, 2023
P2, N=2, Terminated, Sponsor: Domp
Trial completion date: Apr 2024 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Apr 2023; low recruitment rate N=86 --> 2 | Recruiting --> Terminated; low recruitment rate
- |||| ladarixin (DF-2156A) / Dompe
Trial completion date, Trial primary completion date: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Oct 5, 2023
P3, N=327, Recruiting, Sponsor: Domp
N=86 --> 2 | Recruiting --> Terminated; low recruitment rate Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025
- | ladarixin (DF-2156A) / Dompe
Trial completion date, Trial primary completion date: A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved (clinicaltrials.gov) - Oct 5, 2023
P2, N=25, Active, not recruiting, Sponsor: Domp
Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025 Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Oct 2023
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
Enrollment change, Trial withdrawal, Metastases: Ladarixin With Sotorasib in Advanced NSCLC - Phase II (clinicaltrials.gov) - Aug 14, 2023
P2, N=0, Withdrawn, Sponsor: NYU Langone Health
Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Oct 2023 N=28 --> 0 | Not yet recruiting --> Withdrawn
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
Enrollment open, Phase classification, Metastases: Ladarixin With Sotorasib in Advanced NSCLC (clinicaltrials.gov) - Aug 9, 2023
P1/2, N=40, Recruiting, Sponsor: NYU Langone Health
N=28 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Recruiting | Phase classification: P1 --> P1/2
- | ladarixin (DF-2156A) / Dompe
Journal: The therapeutic potential of an allosteric non-competitive CXCR1/2 antagonist for diabetic nephropathy. (Pubmed Central) - Jul 20, 2023
Not yet recruiting --> Recruiting | Phase classification: P1 --> P1/2 Treatment with Ladarixin during RSC differentiation prevented high glucose-mediated effects on podocytes and modulated either podocyte or epithelial cell-dependent leucocyte secretion of pro-inflammatory cytokines, suggesting CXCR1/2 antagonists as possible pharmacological approaches for the treatment of diabetic nephropathy.
- || ladarixin (DF-2156A) / Dompe
Clinical, Retrospective data, Journal: Post hoc analysis of a randomized, double-blind, prospective trial evaluating a CXCR1/2 inhibitor in new-onset type 1 diabetes: endo-metabolic features at baseline identify a subgroup of responders. (Pubmed Central) - Jul 10, 2023
P2
In a recent randomized, multicenter trial (NCT02814838) a short-term anti-inflammatory treatment with ladarixin (LDX; an inhibitor of the CXCR1/2 chemokine receptors) did not show benefit on preserving residual beta cell function in new-onset type 1 diabetes...As we found differences in endo-metabolic and immunologic parameters within this subgroup, this generates the hypothesis that the interactions between host factors and drug action can contribute to its efficacy. Further research is needed to evaluate this hypothesis.
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Metastases: Ladarixin With Sotorasib in Advanced NSCLC (clinicaltrials.gov) - Jun 15, 2023
P1, N=40, Not yet recruiting, Sponsor: NYU Langone Health
Further research is needed to evaluate this hypothesis. N=12 --> 40 | Trial completion date: Apr 2025 --> Jul 2026 | Initiation date: Apr 2023 --> Jul 2023 | Trial primary completion date: Apr 2024 --> Jul 2025
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
New P2 trial, Metastases: Ladarixin With Sotorasib in Advanced NSCLC - Phase II (clinicaltrials.gov) - Apr 18, 2023
P2, N=28, Not yet recruiting, Sponsor: NYU Langone Health
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
New P1 trial, New P1/2 trial, Metastases: Ladarixin With Sotorasib in Advanced NSCLC (clinicaltrials.gov) - Apr 18, 2023
P1, N=12, Not yet recruiting, Sponsor: NYU Langone Health
- ladarixin (DF-2156A) / Dompe
Single cell RNA sequencing analysis of tumor responses to triple drug oral immunotherapy in dogs with osteosarcoma (P951) (Exhibit Hall; Poster Board No. P951) - Apr 11, 2023 - Abstract #IMMUNOLOGY2023IMMUNOLOGY_320;
Evaluation of changes to the cellular proportions following treatment revealed a marked reduction in macrophages, which suggests the combination immunotherapy was able to alter the tumor microenvironment. Overall, this study provides unique insights into the heterogeneity within canine osteosarcoma tumors and highlights the impacts of adjuvant immunotherapy on tumor infiltrating immune cell transcriptional programs.
- ladarixin (DF-2156A) / Dompe
CXCR1/2 inhibition ameliorates clinical lesions in experimental mucous membrane pemphigoid () - Mar 4, 2023 - Abstract #ISID2023ISID_1728;
Our data indicate that pharmacological inhibition of CXCR1/2 represents a promising treatment for MMP. In particular, conjunctival application of DF2156A appeared as novel therapeutic avenue for MMP patients with ocular involvement.
- reparixin (DF 1681Y) / Dompe, ladarixin (DF-2156A) / Dompe
Allosteric inhibition of CXCR1/2 by an orally bioavailable chemokine receptor inhibitor attenuates allergic lung inflammation in mice (Convention Center, Lobby Level, Hall 2) - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1531;
These observations indicate that allosteric inhibition of CXCR1/2 by an orally bioavailable chemokine receptor-inhibitor is sufficient to attenuate Th2/Th17-associated allergic lung inflammation. Oral ladarixin maybe an effective therapeutic strategy in asthma.
- | ladarixin (DF-2156A) / Dompe
Preclinical, Journal: Stress-related Testicular Changes in Wistar and Sprague-Dawley Rats Following Oral Administration of an Interleukin-8 Inhibitor. (Pubmed Central) - Dec 23, 2022
We describe testicular changes in Wistar and Sprague-Dawley rats following oral administration of DF2156A, a novel allosteric inhibitor of the CXCR1/CXCR2 receptors of interleukin-8...Sperm analysis in terms of motility, morphology and number of sperm cells was altered in males presenting with morphological changes in the testes. Sprague-Dawley rats with testicular changes were more numerous and with more pronounced lesions than were Wistar rats.
- |||| ladarixin (DF-2156A) / Dompe
Trial completion date, Trial primary completion date: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Nov 22, 2022
P3, N=327, Recruiting, Sponsor: Domp
Sprague-Dawley rats with testicular changes were more numerous and with more pronounced lesions than were Wistar rats. Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2023 --> Mar 2024
- | ladarixin (DF-2156A) / Dompe
Journal: CXCR1/2 dual-inhibitor ladarixin reduces tumour burden and promotes immunotherapy response in pancreatic cancer. (Pubmed Central) - Nov 18, 2022
Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2023 --> Mar 2024 Ladarixin in combination with anti-PD-1 might represent an extremely effective approach for the treatment of immunotherapy refractory PDAC, allowing pro-tumoral to immune-permissive microenvironment conversion.
- || ladarixin (DF-2156A) / Dompe
Clinical, Journal: Ladarixin, an inhibitor of IL-8 receptors CXCR1 and CXCR2, in new-onset type 1 diabetes: a multicenter, randomized, double-blind, placebo-controlled trial. (Pubmed Central) - Aug 5, 2022
Ladarixin in combination with anti-PD-1 might represent an extremely effective approach for the treatment of immunotherapy refractory PDAC, allowing pro-tumoral to immune-permissive microenvironment conversion. In newly diagnosed patients with type 1 diabetes, short-term LDX treatment had no appreciable effect on preserving residual beta cell function.
- ||| ladarixin (DF-2156A) / Dompe
Enrollment open: CONSERVA: Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes. (clinicaltrials.gov) - Aug 2, 2022
P2, N=86, Recruiting, Sponsor: Domp
In newly diagnosed patients with type 1 diabetes, short-term LDX treatment had no appreciable effect on preserving residual beta cell function. Not yet recruiting --> Recruiting
- |||| ladarixin (DF-2156A) / Dompe
New P2 trial: CONSERVA: Clinical Trial on Ladarixin Adjunctive Therapy to Improve Glycemic Control in Type 1 Diabetes. (clinicaltrials.gov) - May 10, 2022
P2, N=86, Not yet recruiting, Sponsor: Domp
- ||| ladarixin (DF-2156A) / Dompe
Enrollment closed, Enrollment change: A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved (clinicaltrials.gov) - May 3, 2022
P2, N=25, Active, not recruiting, Sponsor: Domp
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=75 --> 25
- ladarixin (DF-2156A) / Dompe
The role of CXCR1/2 dual inhibitor ladarixin on tumor burden and immunotherapy response in pancreatic cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6077;
Recruiting --> Active, not recruiting | N=75 --> 25 Ladarixin in combination with anti-PD-1 might represent an effective approach for the treatment of PDAC, converting a protumoral into an immunopermissive microenvironment in PDAC subtypes usually refractory to immunotherapy.
- Actemra IV (tocilizumab) / Roche, JW Pharma, ladarixin (DF-2156A) / Dompe
Combined IL-6 and IL-8 inhibition to overcome mesenchymal stem cell (MSC)-induced resistance to antimetastatic drugs in osteosarcoma. (Available On Demand; 252) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3805;
EV-associated TGFβ together with EV-RNA induce iMSCs development in OS. Ladarixin in combination with tocilizumab reduced metastasis formation in a xenograft mouse model of OS, and, importantly, may prevent the occurrence of iMSC-induced tumor resistance to antimetastatic drugs.
- | ladarixin (DF-2156A) / Dompe
Enrollment change, Trial withdrawal: Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes (clinicaltrials.gov) - Feb 1, 2022
P2, N=0, Withdrawn, Sponsor: Domp
Ladarixin in combination with tocilizumab reduced metastasis formation in a xenograft mouse model of OS, and, importantly, may prevent the occurrence of iMSC-induced tumor resistance to antimetastatic drugs. N=38 --> 0 | Not yet recruiting --> Withdrawn
- | ladarixin (DF-2156A) / Dompe
Journal: CXCR1/2 Inhibitor Ladarixin Ameliorates the Insulin Resistance of 3T3-L1 Adipocytes by Inhibiting Inflammation and Improving Insulin Signaling. (Pubmed Central) - Nov 21, 2021
Herein, differentiated 3T3-L1-adipocytes were subjected to high glucose or inflammatory conditions or the combination of both and then treated with ladarixin, a CXCR1/2 inhibitor. The results obtained point towards the positive regulation by ladarixin on insulin sensitivity, glucose transporters GLUT1 and GLUT4, cytokine proteome profile and lipid metabolism, thus suggesting ladarixin as a potentially helpful treatment in type 2 diabetes mellitus and obesity.
- || ladarixin (DF-2156A) / Dompe
New P2 trial: Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes (clinicaltrials.gov) - Sep 5, 2021
P2, N=38, Not yet recruiting, Sponsor: Domp
- || ladarixin (DF-2156A) / Dompe
New P2 trial, Surgery, Bariatric surgery: Effect of the experimental drug ladarixin administered orally at a dose of 400 mg twice a day on insulin sensitivity. A phase 2, randomized, double-blind, placebo-controlled explorative study in obese patients with pre-diabetes eligible to bariatric surgery. Effetto del farmaco sperimentale ladarixin somministrato per via orale alla dose di 400mg due volte al giorno sulla sensibilit (EUDRACT) - Jun 22, 2021
P2, N=32, Ongoing, Sponsor: DOMP
- |||| ladarixin (DF-2156A) / Dompe
New P2 trial: A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved (clinicaltrials.gov) - May 24, 2021
P2, N=75, Recruiting, Sponsor: Domp
- |||| ladarixin (DF-2156A) / Dompe
Trial primary completion date: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Apr 22, 2021
P3, N=327, Recruiting, Sponsor: Domp
The results obtained point towards the positive regulation by ladarixin on insulin sensitivity, glucose transporters GLUT1 and GLUT4, cytokine proteome profile and lipid metabolism, thus suggesting ladarixin as a potentially helpful treatment in type 2 diabetes mellitus and obesity. Trial primary completion date: Jun 2022 --> Jun 2023
- || ladarixin (DF-2156A) / Dompe
New P1 trial: A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers (clinicaltrials.gov) - Apr 22, 2021
P1, N=36, Completed, Sponsor: Domp
- |||||| ladarixin (DF-2156A) / Dompe
Enrollment open: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Jan 26, 2021
P3, N=327, Recruiting, Sponsor: Domp
Trial primary completion date: Jun 2022 --> Jun 2023 Not yet recruiting --> Recruiting
- | ladarixin (DF-2156A) / Dompe
New P3 trial: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual ?-cell Function (clinicaltrials.gov) - Nov 12, 2020
P3, N=327, Not yet recruiting, Sponsor: Domp
- | ladarixin (DF-2156A) / Dompe
Trial completion: A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes (clinicaltrials.gov) - Nov 13, 2019
P2, N=76, Completed, Sponsor: Domp
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | ladarixin (DF-2156A) / Dompe
Enrollment closed: A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes (clinicaltrials.gov) - Jun 13, 2018
P2, N=72, Active, not recruiting, Sponsor: Domp
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | ladarixin (DF-2156A) / Dompe
Trial completion date, Trial primary completion date: A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes (clinicaltrials.gov) - Apr 17, 2018
P2, N=72, Recruiting, Sponsor: Domp
Recruiting --> Active, not recruiting Trial completion date: Nov 2018 --> Sep 2019 | Trial primary completion date: Aug 2018 --> Apr 2019
- | ladarixin (DF-2156A) / Dompe
New P2 trial: A Phase 2, Multicentre, Randomized, Double-blind, Placebo-controlled Study in Patients With New-onset Type 1 Diabetes (clinicaltrials.gov) - Jun 28, 2016
P2, N=72, Recruiting, Sponsor: Domp
- ladarixin (DF-2156A) / Dompe
Trial termination: Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid (clinicaltrials.gov) - Jul 31, 2012
P2, N=4, Terminated, Sponsor: Domp
Recruiting --> Terminated; Lack of efficacy observed at 1/3 of the enrollment at investigated dosage. No results available.
- ladarixin (DF-2156A) / Dompe
Enrollment change: Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid (clinicaltrials.gov) - Jul 31, 2012
P2, N=4, Terminated, Sponsor: Domp
No results available. N=12 --> 4
- ladarixin (DF-2156A) / Dompe
New P2 trial: Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid (clinicaltrials.gov) - Apr 3, 2012
P2, N=4, Terminated, Sponsor: Domp