Muscatine, Iowa
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.
Phase
3Span
101 weeksSponsor
Alvotech Swiss AGRuse
Recruiting
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
Phase
3Span
268 weeksSponsor
AstraZenecaRuse
Recruiting
Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)
TACTI-004 is a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (major histocompatibility complex (MHC) class II agonist) in combination with pembrolizumab (programmed cell death protein 1 (PD-1) antagonist) and chemotherapy. The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (SoC, pembrolizumab and histology-based chemotherapy) compared to placebo combined with SoC in programmed death-ligand 1 (PD-L1) unselected population as assessed by: - Overall survival [OS] - Progression-free survival [PFS] per RECIST 1.1 The trial is planned to be conducted in countries in Asia, Australia, Europe and North and South America in approximately 175 experienced clinical sites.
Phase
3Span
237 weeksSponsor
Immutep S.A.S.Ruse
Recruiting
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Phase
3Span
152 weeksSponsor
TakedaRuse
Recruiting
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
Phase
3Span
104 weeksSponsor
GlaxoSmithKlineRuse
Recruiting
Healthy Volunteers
A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy. All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36). Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment period and Transition period. During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36. After treatment discontinuation, patients will undergo a Safety follow-up period for 4 weeks, up to week 40.
Phase
3Span
70 weeksSponsor
mAbxience Research S.L.Ruse
Recruiting
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo
Phase
3Span
192 weeksSponsor
PfizerRuse
Recruiting
Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
Phase
N/ASpan
118 weeksSponsor
University National Heart HospitalRuse
Recruiting
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Phase
3Span
128 weeksSponsor
Arrowhead PharmaceuticalsRuse
Recruiting
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Phase
3Span
119 weeksSponsor
Arrowhead PharmaceuticalsRuse
Recruiting