Le Soler, France
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease
Phase
2Span
75 weeksSponsor
Eli Lilly and CompanyClermont, Florida
Recruiting
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
Phase
2Span
463 weeksSponsor
Janssen Pharmaceutica N.V., BelgiumClermont, Florida
Recruiting
Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
Phase
N/ASpan
201 weeksSponsor
GAP Innovations, PBCClermont, Florida
Recruiting
Healthy Volunteers
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
Phase
3Span
536 weeksSponsor
AstraZenecaClermont, Florida
Recruiting
Safety and Effectiveness of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
The study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years [whichever occurs first]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits). Eligible patients will be randomized (1:1:1) to the treatment arms (Arm 1, Arm 2, and Arm 3), until one arm stops accrual. Participants will then be randomized (1:1) in the remaining two treatment arms (Arm 1 and Arm 2 or Arm 3). The randomization will be stratified based on the following factors: 1. Brain metastases per investigator assessment; 2. Liver metastases per investigator assessment; and 3. Geography.
Phase
3Span
191 weeksSponsor
BioNTech SEClermont, Florida
Recruiting
Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of BNT327 plus chemotherapy for the Phase 2 part of each substudy. After the analysis of the Phase 2 data (efficacy, safety, and exposure-response), an internal review committee (IRC) will decide whether participants will be treated with BNT327 at dose level 1 or 2 in the Phase 3 part of the substudies. After dose selection, the selected dose will be used for all participants in the study. For the Phase 3 parts of both substudies, an independent data monitoring committee (IDMC) will be established as needed to provide independent review of the data during the study. The sponsor may decide not to perform or stop recruiting participants in the Phase 2 part of the study depending on data generated in the BNT327-01 (NCT06449209) and BNT327-02 (NCT06449222) studies. The sponsor may also choose not to continue all substudies.
Phase
2/3Span
312 weeksSponsor
BioNTech SEClermont, Florida
Recruiting
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Phase
3Span
376 weeksSponsor
Boehringer IngelheimClermont, Florida
Recruiting
A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
Phase
3Span
314 weeksSponsor
Eli Lilly and CompanyClermont, Florida
Recruiting
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
Phase
2Span
151 weeksSponsor
Eisai Inc.Clermont, Florida
Recruiting
Clermont, Florida
Recruiting