itacitinib (INCB039110) / Incyte 
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  • ||||||||||  itacitinib (INCB039110) / Incyte
    Clinical Trial,Phase II, Journal:  Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. (Pubmed Central) -  Jun 20, 2024   
    Patients with persistent inflammation refractory to itacitinib showed progressive CD8 T cell terminal differentiation and progressive disease. Thus, JAK inhibition may improve the efficacy of anti-PD-1 immunotherapy by pivoting T cell differentiation dynamics.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Mar 22, 2024   
    P1,  N=31, Active, not recruiting, 
    stimulation induced proteins in a single generic induction pattern over time whereas TNF?-induced proteins showed distinct grouping of Recruiting --> Active, not recruiting
  • ||||||||||  dezapelisib (INCB040093) / Incyte
    Trial completion date, Trial primary completion date:  Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) -  Mar 13, 2024   
    P1,  N=121, Active, not recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment open:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Mar 13, 2024   
    P1,  N=31, Recruiting, 
    Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024 Active, not recruiting --> Recruiting
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Phase classification, Cytokine release syndrome, Post-transplantation:  Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (clinicaltrials.gov) -  Mar 12, 2024   
    P1,  N=32, Recruiting, 
    Active, not recruiting --> Recruiting Phase classification: P1a/1b --> P1
  • ||||||||||  Inrebic (fedratinib) / BMS, Jakafi (ruxolitinib) / Incyte, itacitinib (INCB039110) / Incyte
    Preclinical, Journal:  Differential Effects of JAK1 vs. JAK2 Inhibition in Mouse Models of Hemophagocytic Lymphohistiocytosis. (Pubmed Central) -  Mar 6, 2024   
    Consistent with its superior clinical effects, ruxolitinib exerted the greatest transcriptional changes in CD8 T cells and monocytes, targeting more genes across several biologic pathways, most notably JAK-dependent pro-inflammatory signaling. We conclude that JAK1 inhibition is sufficient to curtail CpG-induced disease, but combined inhibition of JAK1 and JAK2 is needed to best control LCMV-induced immunopathology.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Feb 22, 2024   
    P1,  N=30, Active, not recruiting, 
    Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Feb 2024 --> Jun 2024 Trial completion date: Feb 2027 --> Apr 2025 | Trial primary completion date: Feb 2027 --> Apr 2025
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Combination therapy:  Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) -  Feb 21, 2024   
    P1/2,  N=23, Active, not recruiting, 
    Trial completion date: Feb 2027 --> Apr 2025 | Trial primary completion date: Feb 2027 --> Apr 2025 Trial completion date: Jan 2027 --> Jun 2027
  • ||||||||||  itacitinib (INCB039110) / Incyte
    ITACITINIB FOR THE PREVENTION OF IMMUNE EFFECTOR CELL THERAPY (Hall 3 South) -  Feb 14, 2024 - Abstract #EBMT2024EBMT_1900;    
    P2
    Incidence of grade 3/4 neutropenia and thrombocytopenia not resolved at Day 28 was higher with itacitinib vs placebo. Severe infection rates were comparable
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Feb 13, 2024   
    P1,  N=30, Active, not recruiting, 
    Severe infection rates were comparable Recruiting --> Active, not recruiting
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial termination:  GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) -  Jan 23, 2024   
    P2/3,  N=155, Terminated, 
    Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025 Active, not recruiting --> Terminated; The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial termination:  FLIGHT: Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD (clinicaltrials.gov) -  Jan 22, 2024   
    P2,  N=3, Terminated, 
    Active, not recruiting --> Terminated; The study was terminated due to insufficient efficacy to support moving into Part 2 of the study; there were no safety concerns that contributed to this decision. Trial completion date: Oct 2025 --> Jan 2023 | Active, not recruiting --> Terminated; PI left institution
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed, Enrollment change:  A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (clinicaltrials.gov) -  Nov 13, 2023   
    P2,  N=18, Active, not recruiting, 
    Background: Prophylactic treatment with itacitinib (ITA), a potent, selective oral Janus kinase (JAK)1 inhibitor, to manage onset and severity of cytokine release syndrome (CRS) and immune effector cell Recruiting --> Active, not recruiting | N=100 --> 18
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial termination, Trial primary completion date:  A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov) -  Nov 8, 2023   
    P2,  N=15, Terminated, 
    Initiation date: Oct 2023 --> Jan 2024 Trial completion date: Jun 2024 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Sep 2023; Slow enrollment and PI departure
  • ||||||||||  Review, Journal:  Novel janus-kinase (JAK) inhibitors in myelofibrosis. (Pubmed Central) -  Nov 7, 2023   
    This review includes the current status of JAKi treatment for myelofibrosis, mainly focusing on investigational JAKis; jaktinib, lestaurtinib, itacitinib, gandotinib, BMS-911543, ilginatinib, TQ05105, and flonoltinib maleate...In patients with myelofibrosis, momelotinib was effective in treating anemia, whereas jaktinib was effective in both anemia and Total Symptom Score (TSS)...The increasing variety of JAKis will allow for more personalized treatment options for myelofibrosis in the future. The potential impact on disease progression, molecular responses, and the duration of this response will become important parameters for future evaluations of these drugs.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    HLH-JAK, the First Open-Label, Phase II Study Evaluating Anti-JAK1 Itacitinib, for Non Severe HLH in Adults (SDCC - Room 24) -  Nov 3, 2023 - Abstract #ASH2023ASH_4789;    
    P2
    Kinase inhibitors blocking JAK activity, particularly Ruxolitinib a JAK1/2 inhibitor, have shown some efficacy in murine genetic models of HLH...In the absence of organ failure, fibrinogen<0.5 g/L, platelets<20 G/l, the need for ICU transfer, or etoposide treatment, HLH patients were considered non-severe...The second stage of HLH JAK is ongoing. Clinical trial information: NCT NCT05063110
  • ||||||||||  itacitinib (INCB039110) / Incyte, Inqovi (decitabine/cedazuridine) / Otsuka
    Preliminary Results from a Phase 1b Dose De-Escalation Stage of Abnl-Marro 001: An International MDS/MPN Working Group Study (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2300;    
    P1/2
    Summary/Conclusion : Based on the preliminary results of the phase 1b study, the dosing schedule of 35 mg DEC / 100 mg CED daily for 5 days in combination with itacitinib 300 mg daily for 28 days was selected as the RP2D as it balanced clinical efficacy with an acceptable and manageable safety profile. This regimen and dose are being utilized in a 28-day cycle in the ongoing global, multi-center phase 2 study (NCT04061421).
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Itacitinib for the Prevention of Immune Effector Cell Therapy (SDCC - Room 6B) -  Nov 3, 2023 - Abstract #ASH2023ASH_1412;    
    P2
    Incidence of grade 3/4 neutropenia and thrombocytopenia not resolved at Day 28 was higher with itacitinib vs placebo. Rates of severe infections were comparable in both arms.
  • ||||||||||  Trial completion date, Trial primary completion date, Tumor mutational burden:  The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (clinicaltrials.gov) -  Oct 3, 2023   
    P2,  N=400, Active, not recruiting, 
    Rates of severe infections were comparable in both arms. Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Apr 2024 --> Dec 2024
  • ||||||||||  itacitinib (INCB039110) / Incyte, Xiidra (lifitegrast) / Novartis, velpatasvir (GS-5816) / Gilead
    Journal:  Virtual screening indicates potential inhibitors of the P2X7 receptor. (Pubmed Central) -  Sep 11, 2023   
    In vitro studies in mouse cells confirmed the inhibitory activity of the indicated ligands on the P2X7 receptor by applying virtual screening. The behavior of protein bonded to the ligands was verified by analysis of the molecular dynamic simulation trajectories for four of the most potent inhibitor compounds, indicating that the ligands velpatasvir, itacitinib, lithospermic acid and narirutin remained in the binding site indicated by molecular docking.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion, Cytokine release syndrome:  INCB 39110-211: A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy (clinicaltrials.gov) -  Aug 31, 2023   
    P2,  N=112, Completed, 
    The behavior of protein bonded to the ligands was verified by analysis of the molecular dynamic simulation trajectories for four of the most potent inhibitor compounds, indicating that the ligands velpatasvir, itacitinib, lithospermic acid and narirutin remained in the binding site indicated by molecular docking. Active, not recruiting --> Completed
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date, Adverse events, Checkpoint inhibition:  Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors (clinicaltrials.gov) -  Aug 29, 2023   
    P2,  N=25, Recruiting, 
    Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Aug 2026 --> Nov 2026 | Initiation date: Jul 2023 --> Oct 2023 | Trial primary completion date: Aug 2025 --> Nov 2025
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed, Trial completion date, Trial primary completion date, Metastases:  NCI-2018-00615: Itacitinib in Treating Patients With Refractory Metastatic/Advanced Sarcomas (clinicaltrials.gov) -  Aug 29, 2023   
    P1,  N=27, Active, not recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Aug 2026 --> Nov 2026 | Initiation date: Jul 2023 --> Oct 2023 | Trial primary completion date: Aug 2025 --> Nov 2025 Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Dec 2023 | Trial primary completion date: Jan 2024 --> Mar 2023
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Aug 16, 2023   
    P1,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Dec 2023 | Trial primary completion date: Jan 2024 --> Mar 2023 Trial completion date: Jan 2023 --> Feb 2027 | Trial primary completion date: Jan 2023 --> Feb 2027
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed, Trial completion date, Trial primary completion date, Cytokine release syndrome:  INCB 39110-211: A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy (clinicaltrials.gov) -  Jul 14, 2023   
    P2,  N=111, Active, not recruiting, 
    At P28, STAT1 signalling tended to be lower in the patellar tendon which had grown by increasing cross-sectional area and inhibiting STAT activation in vitro improved mechanical properties in engineered human ligaments. Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> Jul 2023 | Trial primary completion date: Jun 2023 --> Feb 2023
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment open, Cytokine release syndrome, Post-transplantation:  Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (clinicaltrials.gov) -  Jul 7, 2023   
    P1a/1b,  N=32, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> Jul 2023 | Trial primary completion date: Jun 2023 --> Feb 2023 Not yet recruiting --> Recruiting
  • ||||||||||  dezapelisib (INCB040093) / Incyte
    Trial completion date, Trial primary completion date:  Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) -  Jun 7, 2023   
    P1,  N=121, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Feb 2023 --> Feb 2024
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (clinicaltrials.gov) -  Jun 6, 2023   
    P2/3,  N=155, Active, not recruiting, 
    Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Feb 2023 --> Feb 2024 Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial initiation date, Cytokine release syndrome, Post-transplantation:  Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (clinicaltrials.gov) -  May 18, 2023   
    P1a/1b,  N=32, Not yet recruiting, 
    Recruiting --> Active, not recruiting Initiation date: Apr 2023 --> Jul 2023
  • ||||||||||  itacitinib (INCB039110) / Incyte, Actemra IV (tocilizumab) / Roche, JW Pharma
    Enrollment change, Trial termination, Combination therapy:  Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease (clinicaltrials.gov) -  May 11, 2023   
    P1,  N=1, Terminated, 
    Initiation date: Apr 2023 --> Jul 2023 N=24 --> 1 | Recruiting --> Terminated; The primary reason for study closure is slow enrollment.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial initiation date, Trial primary completion date, Adverse events, Checkpoint inhibition:  Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors (clinicaltrials.gov) -  May 10, 2023   
    P2,  N=25, Not yet recruiting, 
    N=24 --> 1 | Recruiting --> Terminated; The primary reason for study closure is slow enrollment. Trial completion date: Apr 2026 --> Aug 2026 | Initiation date: Mar 2023 --> Jul 2023 | Trial primary completion date: Apr 2025 --> Aug 2025