Rezurock (belumosudil) / Romeck Pharma, Sanofi 
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 0 Diseases   12 Trials   12 Trials   593 News 


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  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
    Journal:  Skin Cancer after Ruxolitinib or Belumosudil. (Pubmed Central) -  Sep 25, 2023   
    No abstract available No abstract available
  • ||||||||||  Sarclisa (isatuximab-irfc) / Sanofi
    Trial completion date, Trial primary completion date, Combination therapy:  Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) -  Sep 15, 2023   
    P1/2,  N=123, Recruiting, 
    We note that predicted DNN-Fibrosis Scores tended to be lower for participants with higher mRSS ( >25). Trial completion date: Feb 2026 --> Nov 2028 | Trial primary completion date: Feb 2026 --> Nov 2028
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte, Imbruvica (ibrutinib) / AbbVie, J&J
    Review, Journal:  Updates in chronic graft-versus-host disease management. (Pubmed Central) -  Sep 11, 2023   
    Steroid-refractory cGvHD management has recently experienced significant improvement since ibrutinib and ruxolitinib were approved for patients that failed at least one line of treatment and belumosudil for patients that failed two lines. These recently approved drugs will be discussed in this review, along with perspectives regarding cGVHD management and additional promising drug in development.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    PK/PD data, Journal:  Belumosudil Impacts Immunosuppression Pharmacokinetics in Patients with Chronic Graft-Versus-Host Disease. (Pubmed Central) -  Aug 28, 2023   
    We recommend empiric dose reductions of 25% for tacrolimus and 25-50% for sirolimus when adding belumosudil, as well as close monitoring of IS levels during the initial weeks of belumosudil therapy. Future studies are warranted to better describe the impact of belumosudil on patients taking CYP3A inhibitors.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
    Enrollment open, Trial completion date, Trial primary completion date, Immunomodulating:  Immunological Tolerance in Patients With Mismatched Kidney Transplants (clinicaltrials.gov) -  Aug 18, 2023   
    P1,  N=16, Recruiting, 
    Future studies are warranted to better describe the impact of belumosudil on patients taking CYP3A inhibitors. Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Aug 2026 | Trial primary completion date: Apr 2025 --> Aug 2025
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion:  Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov) -  Apr 18, 2023   
    P2,  N=30, Completed, 
    Because macrophages are the major players in immune response, tissue regeneration, renewal, and homeostasis, and development of many diseases, including cancer, the data compiled here will help in designing novel or improved therapies in many clinical applications. Recruiting --> Completed
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
    New P1 trial, Immunomodulating:  Immunological Tolerance in Patients With Mismatched Kidney Transplants (clinicaltrials.gov) -  Apr 10, 2023   
    P1,  N=16, Not yet recruiting, 
  • ||||||||||  Sarclisa (isatuximab-irfc) / Sanofi
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) -  Mar 21, 2023   
    P1/2,  N=123, Recruiting, 
    Completed --> Terminated; Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns. N=72 --> 123 | Trial completion date: Jun 2028 --> Feb 2026 | Trial primary completion date: Jun 2028 --> Feb 2026
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial termination:  KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Mar 17, 2023   
    P2,  N=60, Terminated, 
    N=72 --> 123 | Trial completion date: Jun 2028 --> Feb 2026 | Trial primary completion date: Jun 2028 --> Feb 2026 Completed --> Terminated; Sponsor decision due to slow enrollment and strategic consideration; not driven by any safety concerns.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
    BELUMOSUDIL AND RUXOLITINIB COMBINATION THERAPY FOR TREATMENT OF STEROID-REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE (ePoster Area) -  Feb 11, 2023 - Abstract #EBMT2023EBMT_1405;    
    This retrospective analysis demonstrates that treatment of steroid-refractory cGVHD with B+R is feasible, safe and tolerable. B+R led to a clinical response in approximately 43% of patients and stabilized disease in 50% of patients while also allowing prednisone dose-reduction in several patients.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion:  dcSSC: Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis (clinicaltrials.gov) -  Jan 6, 2023   
    P2,  N=10, Completed, 
    B+R led to a clinical response in approximately 43% of patients and stabilized disease in 50% of patients while also allowing prednisone dose-reduction in several patients. Active, not recruiting --> Completed
  • ||||||||||  Olumiant (baricitinib) / Incyte, Eli Lilly
    Baricitinib for Refractory Chronic Graft-Versus-Host Disease (cGVHD): Results of a Phase 1/2 Study () -  Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_962;    
    P1/2
    Baricitinib showed favorable safety and efficacy in multi-refractory cGVHD, with rapid, durable multi-organ responses. The well-tolerated and alternate safety profile of baricitinib may provide an advantage over other JAK inhibitors and warrants further large-scale study in cGVHD.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Belumosudil Impacts Immunosuppression Pharmacokinetics in Patients with Chronic Graft-Versus-Host Disease (World Center Marriott Grand 8B: Enter through Salon 11; In-Person) -  Dec 15, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_1301;    
    Based on these findings, empiric dose reductions for SIRO and TAC should be considered with co-administration of BEL with close monitoring of IST levels during initial months of concurrent therapy. Future studies are needed to confirm BEL impact on IST pharmacokinetics.