Yuxi, China

ZILRETTA in Subjects With Shoulder Osteoarthritis

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of ZILRETTA in subjects with glenohumeral OA. This study will be conducted at approximately 25 study sites in the United States. Subjects will be screened to confirm the diagnosis of OA and eligibility based on the Inclusion and Exclusion Criteria. Approximately 250 male or female subjects, 50 to 80 years of age inclusive, will be enrolled, randomized to 1 of 3 treatment groups (2:2:1), and treated with a single IA injection of either: - Treatment Arm 1: 32 mg ZILRETTA, - Treatment Arm 2: 40 mg Immediate Release Triamcinolone (TCA-IR), or - Treatment Arm 3: placebo (normal saline). ZILRETTA, TCA-IR, or normal saline placebo will be administered as a single IA injection with a 24-week follow-up period with a primary endpoint at Week 12. The study will involve a Screening period (a minimum of 10 days, up to a maximum of 35 days), pre-treatment phase, dosing at Baseline/Day 1, and 8 additional outpatient visits at Weeks 2, 4, 8, 12, 16, 18, 20, and 24/End of Study (EOS) during the study. At specified times throughout the study, subjects will undergo physical examinations, index shoulder assessments, and index shoulder X-rays; blood will be collected for laboratory safety tests; and vital signs will be collected. Information regarding adverse events (AEs) and prior and concomitant medications and treatments will be collected from the time of signing the Informed Consent Form (ICF) through the Week 24/EOS visit. Information regarding rescue medication usage, Average and Worst daily Pain score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) in the index shoulder, and Sleep Interference (SI) will be completed daily via an electronic diary (eDiary) and reviewed for compliance by site staff at each study visit. At the Screening Visit, subjects will be registered in the eDiary and receive instructions on its use. Subjects will complete accurate pain reporting (APR) and placebo response reduction (PRR) training prior to completing all questionnaires.

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. An approximate total of eligible 207 participants will be randomized to one of the three treatment groups - 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. Placebo The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

The ReNEW (SPIAM-301) trial is a phase 3, randomized, double-masked, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily subcutaneous (SC) injection of elamipretide in subjects who have dry AMD. Subjects will be randomized (2:1) to once daily SC doses of 40 mg elamipretide, or placebo for 96 weeks of treatment by a central randomization and stratified by SD-OCT device type (Heidelberg SPECTRALIS®, ZEISS CIRRUS®) and baseline macular area of photoreceptor loss, defined as an ellipsoid zone-retinal pigment epithelium (EZ-RPE) thickness of 0μm assessed by SD-OCT and ellipsoid zone (EZ) mapping (High Strata ≥ 5.1mm2, Low Strata <5.1mm2). Primary Objective - Evaluate the efficacy of once daily subcutaneous (SC) injections of elamipretide in subjects who have dry age-related macular degeneration (AMD) Secondary Objectives - Evaluate the safety and tolerability of once daily SC injections of elamipretide - Evaluate the Pharmacokinetic (PK) profile of elamipretide and its metabolites

Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

This is a prospective, multi-center, randomized, double-blind, sham-controlled, adaptive study enrolling individuals with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications. Participants will be randomized to receive the ReCET therapy or sham procedure consisting of device insertion without treatment. Participants will be followed for 6 months for the primary endpoint and 12 months in total. After 12 months, participants randomized to the sham arm may cross-over to receive the ReCET procedure.

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 Polymer Film Device to Treat Excessive Palmar Sweating

Protocol TCAAP-PH will investigate TCA use in participants with palmar hyperhidrosis. This is a pilot, open-label, single site study designed to evaluate the safety and efficacy of TCA in participants 18 years of age and older. The study will have a maximum study duration of 4 weeks. This includes screening/baseline, a 1-week treatment period, and a 4 week follow up phone call and exit survey. A total of approximately 30 participants will be enrolled in this study. At the inception of the trial, the age of participants will be 18 years of age or older. Screening/Baseline will occur the same day to confirm the selection criteria for the study are met. Qualified participants in TCAAP-PH will be selected to receive TCA at this visit. Participants will administer TCA to the affected areas of the palms/fingers daily throughout the treatment period. This study is being conducted to evaluate the short-term safety and efficacy of TCA dosed up to 1 week of treatment duration. In addition to safety, another objective of this study is to evaluate short-term efficacy in this population. To evaluate the efficacy, response will be assessed based on the hyperhidrosis disease severity scale (HDSS), an instrument that is widely used to assess the severity of palmar hyperhidrosis by the subject that best reflects his or her experience with sweating of the specified body area. Participants are asked "How would you rate the severity of your hyperhidrosis?" (1) My sweating is never noticeable and never interferes with my daily activities (2) My sweating is tolerable but sometimes interferes with my daily activities (3) My sweating is barely tolerable and frequently interferes with my daily activities (4) My sweating is intolerable and always interferes with my daily activities. A score of 3 or 4 indicates severe hyperhidrosis. A score of 1 or 2 indicates mild or moderate hyperhidrosis. A 1-point improvement in HDSS score has been associated with a 50% reduction in sweat production and a 2-point improvement with an 80% reduction. This tool has been well accepted and used in multiple palmar hyperhidrosis clinical trials as a reliable and reproducible measure of palmar hyperhidrosis severity. In addition, gravimetric sweat production and grip strength measurements will be used to assess the short-term efficacy in this population. The total sample size for the study is estimated to be approximately 30 participants. The TCAAP-PH treatment protocol that is being administered to the study intervention group has been used for other indications (e.g. extraoral wound closures and skin protectants) with minimal risk to patients. Due to the low risk profile of cyanoacrylate, the use of this agent for palmar hyperhidrosis will be evaluated with no significant concern regarding the dosage that will be applied to the affected areas. Dosage is 100 µL once per day, which is sufficient to cover the palmar and phalangeal surface of both hands when properly applied. The solution will be applied in the morning after subjects complete their morning meal and washing routine. The end of the study is defined as the date of the last visit of the last participant in the study. The date of the last visit will be considered the Week 4 phone call.

A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration

In the multiple ascending dose (MAD) part of the study, 4 cohorts, each comprised of 3 participants, will receive IVT injections of EYE201 at one of 4 dosing levels in ascending order in an open label design. The participants will have previously untreated (naïve) BRVO and will receive EYE201. Participants will return for safety and efficacy assessments and sample collection study visits. Participants in the following cohort will receive their first IVT injection of EYE201 once all 3 participants in the previous cohort have received their first dose of EYE201 and completed a predefined safety assessment, and a Dose Escalation Committee has confirmed the absence of dose-limiting toxicity (DLT). Once the last participant in the MAD portion of the study has received their first dose, completed a predefined safety assessment, and the maximum tolerated dose (MTD) either has been determined or declared as not having been reached at the doses tested, 2 of the dose levels will be selected for inclusion in the Part 2 dose-finding study, based on safety and any preliminary efficacy signals observed. The dose-finding part of the study will be randomized and masked to the participants and study site personnel (except the dose preparer and unmasked injecting physician). The study will be split according to whether the participants have treatment naïve or treatment experienced DME or NVAMD.

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis