La Chataigneraie, France
A Study to Assess Safety and Tolerability of PCRX-201 in Subjects With Painful Osteoarthritis of the Knee
The study will consist of two parts, Part A and Part B, which will use PCRX-201 from two different manufacturing processes. A total of 135 eligible subjects, with painful OA of the index knee will be enrolled. Subjects will be randomly assigned to a treatment dose group, stratified by Kellgren-Lawrence (K-L) Grade, in both parts of the study. Enrollment of subjects with K-L Grade 4 will be capped at 4 subjects per dose group in Part A and 8 subjects per dose group in Part B. Enrollment of subjects with K-L Grade 2 or 3 will include a minimum of 4 subjects per Grade per dose group in Part A and a minimum of 8 subjects per Grade per dose group in Part B. This study does not require an equal number of subjects between K-L Grade 2 and 3. All eligible subjects will be pretreated with the same dose of methylprednisolone acetate (40 mg) on Day 1 immediately before treatment with PCRX-201 or placebo. Part A will enroll approximately 45 subjects into 3 dose groups (15 subjects in each treatment group, stratified by K-L Grade as noted above). Part B will enroll approximately 90 subjects into 3 groups (30 subjects in each treatment group, stratified by K-L Grade as noted above). Enrollment in Part B is dependent upon the availability of study drug developed with manufacturing process 2.
Phase
2Span
370 weeksSponsor
Pacira Pharmaceuticals, IncWinter Park, Florida
Recruiting
Winter Park, Florida
Recruiting
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.
Phase
3Span
219 weeksSponsor
AstraZenecaWinter Park, Florida
Recruiting
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants with Early Alzheimer's Disease
Phase
1/2Span
117 weeksSponsor
Voyager TherapeuticsWinter Park, Florida
Recruiting
A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis
Phase
2Span
80 weeksSponsor
Eli Lilly and CompanyWinter Park, Florida
Recruiting
Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist
This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.
Phase
2Span
46 weeksSponsor
AstraZenecaWinter Park, Florida
Recruiting
Healthy Volunteers
A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease
Phase
1/2Span
48 weeksSponsor
Ventus Therapeutics U.S., Inc.Winter Park, Florida
Recruiting
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
Phase
2Span
110 weeksSponsor
Eli Lilly and CompanyWinter Park, Florida
Recruiting
Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
Phase
4Span
123 weeksSponsor
Regeneron PharmaceuticalsWinter Park, Florida
Recruiting
A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease
Phase
2Span
75 weeksSponsor
Eli Lilly and CompanyWinter Park, Florida
Recruiting