Covington

Researchers are investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are investigating the safety and effectiveness of topical roflumilast 0.3% foam in treating Hidradenitis Suppurativa (HS), a condition sharing inflammatory pathways with psoriasis. This phase 2a, open-label study explores using roflumilast both as a stand-alone treatment for mild disease and as an add-on therapy for maintenance and flare control in moderate to severe HS. The study includes analysis of gene expression changes before and after treatment to understand the therapy's impact at a molecular level. Participants will apply topical roflumilast foam once daily to affected areas. Those with mild HS (Hurley stage I) will use it as monotherapy, while patients with more advanced disease (Hurley stages II and III) will apply it as an add-on to their stable treatment regimen. The treatment period lasts for 16 weeks, during which gene expression profiling using RNA from tape strip samples will be conducted to assess changes compared to baseline. Throughout the study, participants will undergo evaluations including clinical assessments and gene expression testing at baseline and week 16. Researchers will monitor safety, efficacy, and any side effects related to the treatment. The main outcome measured is the change in gene expression profile at week 16 compared to baseline, providing insight into how the topical therapy affects disease biology over the four-month period.