Sugar Land

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment. During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period. The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

Researchers are studying the dose-response effects of galvokimig compared with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition lasting at least one year. The study focuses on adults aged 18 years and older who have significant disease activity as measured by specific clinical scores and a history of inadequate response to topical treatments or contraindications to them. This phase 2 trial aims to evaluate the safety, effectiveness, and how the drug behaves in the body. Participants will receive either galvokimig or a placebo as an injection. The study uses a randomized, double-blind, placebo-controlled design with multiple doses tested in parallel groups. Treatments are given as solutions for injection, and the study monitors participants over a defined period to assess how the drug works and its safety profile. During the study, participants will undergo assessments including clinical scoring of their skin condition such as the Eczema Area and Severity Index at week 16 to measure response. Researchers will also monitor safety through physical exams, laboratory tests, and medical history reviews. The study requires stopping other systemic or topical treatments before starting and tracks participant adherence and outcomes carefully throughout the study duration.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

This research aims to evaluate the safety and effectiveness of efimosfermin alfa in improving liver fibrosis and resolving steatohepatitis in adults with metabolic dysfunction-associated steatohepatitis (MASH) confirmed by biopsy showing stage F2 or F3 fibrosis. The study compares efimosfermin alfa to a placebo and focuses on individuals with confirmed liver damage and metabolic syndrome features. Participants will receive either efimosfermin alfa or placebo, administered as a drug treatment. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial with three groups. Treatment effects will be assessed over 52 weeks, with a primary focus on liver fibrosis and steatohepatitis changes. The study includes long-term monitoring of liver-related clinical outcomes up to 48 months after randomization. During the study, participants will undergo liver biopsies confirmed by central pathology review, and researchers will monitor liver function and fibrosis improvement. Outcome measures include the proportion of participants showing fibrosis improvement without worsening steatohepatitis, resolution of steatohepatitis with stable fibrosis, and time to liver-related clinical events. Safety and efficacy will be closely evaluated throughout the treatment and follow-up periods.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.