Oklahoma City,, Oklahoma

53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee

This multicenter, double-blind, placebo controlled, randomized study is designed to investigate the safety and efficacy of TPX-100 administered in 4 weekly doses of 200 mg per dose in subjects with tibio-femoral osteoarthritis. The B-score as determined by MRI analysis is the final inclusion criteria, which will be determined by MRI-based assessment. A standardized screening MRI will be obtained on otherwise eligible candidates. For enrolled subjects, the Screening MRI will serve as the Baseline MRI. Enrolled subjects will be assigned randomly to receive either TPX-100 or PBS placebo, 4 weekly IA injections administered into the target knee by fluoroscopy or ultrasound guidance. Subjects will undergo follow-up knee MRIs at Week 27 and Week 53 after the first injection. All MRIs will be read by computer-based, standardized methods, blind to treatment assignment and temporal sequence, to provide the imaging outcome measures. Subjects will complete PROs at Week 1 (Baseline), Week 27 and Week 53. A clinical safety evaluation will be performed at Week 13, and a safety tele-visit or telephone call will be performed at Week 36. Adverse events, regardless of causation, and concomitant medications will be documented at all study visits and at the Week 37 tele-visit/telephone call. Clinical laboratory assessments will be obtained at Screening, Baseline (Week 1), and Weeks 2, 3, 4; and at the in-person follow up visits. All enrolled subjects will be assigned randomly to receive either TPX-100 or PBS placebo, in 4 weekly IA injections administered into the target knee by fluoroscopy or ultrasound guidance.

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Optimizing Body Mass Index (BMI) With TCMCB07, The Paradox Trial

Esprit BTK Post-Approval Study

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. TAK-279 Dose 3 4. Placebo This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

The drugs being tested in this study are called Vedolizumab and Tofacitinib. Vedolizumab and Tofacitinib dual targeted therapy is being tested to treat people with moderate to severe ulcerative colitis (UC) who have experienced inadequate response, loss of response or intolerance to no more than 2 prior tumor necrosis factor (TNF) antagonists. This study will look at the clinical remission in people who take Vedolizumab and Tofacitinib dual targeted therapy. The study will enroll approximately 65 patients. All the participants will be enrolled in a single treatment group to receive dual targeted treatment with Vedolizumab and Tofacitinib for the first 8 weeks: Vedolizumab 300 mg + Tofacitinib 10 mg Only those participants who show a clinical response at Week 8 will transition to Vedolizumab monotherapy for 44 weeks. This multi-center trial will be conducted in the United States and Canada. The overall duration of the study is up to 76 weeks. Participants will be followed up for 26 weeks after the last dose of the study drug for safety.