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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Findings from the Phase III MINT clinical trial (NCT04524273) show that Uplizna (inebilizumab) produced significant short-term clinical improvements in patient- and clinician-assessed outcomes with a tolerable safety profile among adults with generalized myasthenia gravis (gMG).
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Long-term safety and efficacy clinical trial data (NCT03307980) for patients with hemophilia B administered the recombinant adeno-associated virus (AAV) vector gene therapy Beqvez (fidanacogene elaparvovec) show sustained factor IX expression, low bleeding rates, and generally favorable safety outcomes.
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Results from the Phase IV DapaTAVI trial (NCT04696185) show that the addition of Farxiga (dapagliflozin) to standard care in older patients with severe aortic stenosis undergoing transcatheter aortic-valve implantation (TAVI) lowered the risk of death or worsening heart failure by 28%.
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Findings from the Phase III HERCULES trial (NCT04411641) published by The New England Journal of Medicine (NEJM) show tolebrutinib (Sanofi) significantly delayed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).1,2 Investigators said these results demonstrate the potential of tolebrutinib as a first-in-class, brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor in treating nrSPMS, which currently lacks any FDA-approved treatments.
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Findings from the Phase III EXPECTS clinical trial (NCT05429476) show that in patients experiencing a mostly mild posterior circulation stroke who are not candidates for thrombectomy, treatment with alteplase administered 4.5 to 24 hours following stroke onset produced a higher rate of functional independence at 90 days compared to standard care.
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2 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Findings from the Phase IIIb APEX trial (NCT04882098) found that Tremfya (guselkumab) produced a significant reduction in the symptoms of active psoriatic arthritis (PsA) while inhibiting the progression of structural joint damage compared to placebo.1,2 The long-term extension (LTE) data through three years of treatment will continue to evaluate the sustained efficacy of Tremfya in limiting structural damage in patients with active PsA, with full results to be presented at upcoming medical...
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3 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Results from the Phase III SOUL trial (NCT03914326) published by The New England Journal of Medicine show that treatment with daily oral semaglutide produced a significant reduction in the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or both.1,2 Oral semaglutide demonstrated cardiovascular benefits that are consistent with injectable semaglutide and other glucagon-like...
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3 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Findings from the Phase III API-CAT trial (NCT03692065) show that extended anticoagulant therapy with reduced-dose Eliquis (apixaban) at 2.5 mg twice daily was noninferior to the full-dose regimen of 5.0 mg twice daily in preventing recurrent venous thromboembolism in patients with active cancer.1,2 The trial results, published by The New England Journal of Medicine, also show Eliquis significantly lowered the risk of clinically relevant bleeding.
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3 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Data from the Phase IIb PURSUIT trial (NCT06173570) found that AZD0780, a novel proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitor, produced a significant 50.7% decrease in low-density lipoprotein cholesterol (LDL-C) levels when added to standard-of-care statin therapy.1,2 These findings, published by the Journal of the American College of Cardiology (JACC), offer hope to patients who were previously unable to achieve their goals in reducing their cholesterol levels on standard...
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3 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Results from the Phase II ALPACA trial (NCT05565742) published by The New England Journal of Medicine show that lepodisiran (Eli Lilly) produced significant and sustained reductions in lipoprotein(a) levels, demonstrating its potential to address this major genetic risk factor for cardiovascular disease.1,2 Lepodisiran, an investigational, noncanonical, tetraloop, Dicer-substrate small interfering RNA (siRNA) therapy, has been found to limit hepatic production of apolipoprotein(a) in early...
