Ridgeland

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

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 the safety and effectiveness of brenipatide compared to placebo for people with opioid use disorder. This study focuses on participants who are also using buprenorphine, with or without naloxone, as part of their treatment. The trial includes two parts, each with separate groups of participants, to better understand how brenipatide works alongside current therapies in early recovery from opioid use disorder. The study has two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B offers an open-label treatment only. Brenipatide and placebo are given as subcutaneous injections, and buprenorphine is administered either sublingually or buccally. Participants will be enrolled in only one part of the study, with treatment durations potentially lasting up to 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing and study progress. Participants will regularly attend study visits where they will be assessed through urine drug screens and self-reports to measure abstinence from opioid use. They will also maintain study diaries and complete questionnaires to track adherence and effects. The main outcomes measured include the percentage of weeks participants remain abstinent from opioids between weeks 13 and 24, verified by negative drug tests and no self-reported opioid use. Safety and long-term effectiveness will be monitored throughout the study duration.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes with throbbing pain, nausea, vomiting, and sensitivity to light and sound. This study evaluates the safety and effectiveness of atogepant, a medicine approved for preventing migraines in adults, to see how well it works compared to placebo in preventing chronic migraines in participants aged 12 to 17 years. The study is a phase 3, double-blind trial where neither the participants nor the doctors know who receives the medicine or placebo. Participants will be randomly assigned to receive either oral atogepant tablets or placebo tablets once daily for 12 weeks. Following the treatment period, there will be a 4-week follow-up phase. The study involves about 420 participants at approximately 70 sites worldwide. Throughout the study, participants will visit hospitals or clinics regularly to complete daily diaries, undergo medical assessments and blood tests, report any side effects, and complete questionnaires. Researchers will measure the number of participants experiencing adverse events and track changes in the average monthly number of migraine days from the start of the study through week 12.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

This research aims to evaluate the safety and effectiveness of tapinarof cream, 1%, in young children aged 3 months to less than 24 months who have atopic dermatitis. This global Phase 3 study focuses on infants and toddlers with this skin condition, assessing improvements in their skin from baseline through up to 56 weeks. The study compares tapinarof cream with a vehicle cream (placebo) to better understand its effects. Participants will be randomly assigned to receive either tapinarof cream, 1%, or a vehicle cream applied once daily to affected skin areas during the initial Double-Blind period lasting up to 8 weeks. Following this, all participants may enter an Open-Label Period lasting up to 56 weeks, where tapinarof cream will be applied once daily as needed to skin lesions. This design allows researchers to monitor responses to the medication over time and assess longer-term safety and efficacy. Throughout the study, caregivers and researchers will monitor the children's skin condition using a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score, focusing on the proportion of participants achieving clear or almost clear skin and a significant improvement from baseline. Safety assessments and adherence to treatment protocols will be observed. The total study duration includes both the Double-Blind and Open-Label periods, with evaluations spanning up to 56 weeks to gather comprehensive data on treatment outcomes.

Researchers are studying the treatment LTP001 in two groups: healthy adults (Part A) and adults with pulmonary arterial hypertension (PAH) (Part B). The study aims to evaluate the safety, tolerability, and how the body processes LTP001 in healthy volunteers, and to assess the safety and effectiveness of LTP001 in participants with PAH. This trial includes a safety extension period for participants with PAH to monitor longer-term effects. In Part A, healthy adult participants will receive single and multiple ascending doses of LTP001 or placebo to assess safety and pharmacokinetics. Part B involves participants with confirmed PAH who will receive LTP001 or placebo alongside their standard PAH treatments. The study monitors participants from baseline through various treatment periods, including a treatment period of up to 106 weeks in Part B for long-term safety assessment. Participants will undergo evaluations including monitoring for adverse events and serious adverse events from baseline through Day 35 in Part A and through Week 106 in Part B. The study also measures changes in pulmonary vascular resistance (PVR) during Part B at Week 24. Assessments include physical exams, ECGs, and walking tests to evaluate heart and lung function. Researchers will track safety, efficacy, and tolerability throughout the study duration.

This research aims to learn about the safety, how the body processes, and how well the study medicine called nirmatrelvir/ritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but are at risk for severe illness. The study focuses on pediatric patients confirmed to have COVID-19, with early symptoms and risk factors for worsening disease. Participants will receive the study medicine, which is given by mouth, to evaluate its effects. The trial is open-label, meaning both researchers and participants know the treatment being given. The study is designed as a single-arm Phase 2/3 trial conducted at multiple centers. During the study, researchers will measure medicine levels in the blood at specific times to understand drug absorption and processing. They will monitor for any side effects or adverse events up to 34 days after starting treatment. Vital signs and other health indicators will be regularly checked to assess safety and overall health. The total participation period includes treatment and follow-up to gather comprehensive safety and effectiveness data.

Researchers are studying women with nonatypical endometrial hyperplasia (NAEH), a condition where the lining of the uterus becomes too thick but is not cancerous. This condition is often caused by hormone imbalances and can cause abnormal vaginal bleeding or irregular periods. If untreated, NAEH may lead to cancer. Currently, no approved treatments exist for this condition, creating a need for new therapies. This Phase 3 study aims to evaluate whether Mirena, a progesterone-releasing intrauterine device, can help restore the uterine lining to normal and assess its safety compared to oral medroxyprogesterone acetate (MPA).