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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Updated data from the pivotal Phase III ELATIVE trial (NCT04526665) show Iqirvo (elafibranor) significantly improved fatigue in patients with primary biliary cholangitis (PBC) after 52 weeks.1,2 The updated trial results, presented at the European Association for the Study of the Liver congress, demonstrated that these treatment effects were independent of pruritus and bolstered by mechanistic proteomic analyses from the trial, according to the investigators.
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Topline results from the Phase III DESTINY-Breast11 trial (NCT05113251) show that Enhertu (trastuzumab deruxtecan; AstraZeneca and Daiichi Sankyo) followed by standard human epidermal growth factor receptor 2 (HER2)-targeted therapy produced a significant improvement in pathologic complete response (pCR) rates compared to current standard-of-care chemotherapy in patients with high-risk, locally advanced HER2-positive early-stage breast cancer.
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Results from the Phase III MUSA trial show that in women with moderate to severe mixed urinary incontinence (MUI) who were unresponsive to conservative therapies, treatment with onabotulinumtoxinA (Botox) was not found superior to midurethral sling at six months.
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1 week ago | 
appliedclinicaltrialsonline.com | Davy James
Long-term extension (LTE) data from the Phase IIb/III QUASAR trial (NCT04033445) program show adult patients with moderately to severely active ulcerative colitis (UC) administered Tremfya (guselkumab) achieved significant rates of sustained clinical remission and endoscopic remission 92 weeks.
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2 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Weekly semaglutide was found to significantly improve steatohepatitis and fibrosis while enhancing metabolic markers and noninvasive liver health measures in patients with metabolic dysfunction–associated steatohepatitis (MASH), according to results of a planned interim analysis of the Phase III ESSENCE trial (NCT04822181) published by The New England Journal of Medicine.1,2 The authors noted that these findings indicate semaglutide not only targets hepatic pathology, but also treats the...
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2 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Results of the Phase III MATINEE trial (NCT04133909) show that Nucala (mepolizumab) produced a significant reduction in the annualized rate of moderate or severe exacerbations and prolonged time to first exacerbation in patients with eosinophilic chronic obstructive pulmonary disease (COPD) receiving triple inhaled therapy.1,2 These findings, published by The New England Journal of Medicine, reinforce the role of targeted biologics in personalized therapeutic approaches for COPD with type 2...
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2 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
The FDA has approved AbbVie’s Rinvoq (upadacitinib) 15 mg once daily for the treatment of adults with giant cell arteritis (GCA) based on findings from the pivotal Phase III SELECT-GCA trial (NCT03725202).1-3 The regulatory action marks the ninth overall approval for Rinvoq across rheumatology, gastroenterology, and dermatology and makes it first oral Janus Kinase (JAK) inhibitor indicated for the treatment of GCA in adult patients.
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2 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Early interim data from cohort 4 of the Phase IIb SunRISe-1 trial (NCT04640623) evaluating the novel bladder cancer treatment TAR-200 (Johnson & Johnson) in the treatment of Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC) show a disease-free survival (DFS) rate of 80%, with 94.2% of patients able to avoid bladder removal.1,2 The promising findings for the investigational intravesical gemcitabine releasing system, presented at the 2025 American...
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2 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Interim data from the Phase III KEYNOTE-689 trial (NCT03765918) show that perioperative treatment with Keytruda (pembrolizumab; Merck) significantly lowered the risk of disease progression or recurrence in patients with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to standard of care (SOC) radiotherapy.1,2 These findings, presented at the American Association for Cancer Research Annual Meeting, are the first positive clinical trial...
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3 weeks ago | 
appliedclinicaltrialsonline.com | Davy James
Findings from the 12-week Phase II Advance-HTN trial (NCT05769608) show that lorundrostat significantly lowered systolic blood pressure (SBP) in patients with uncontrolled and treatment-resistant hypertension.
