Indianapolis

Researchers are evaluating the effect of a gum containing an active compound called MIIP-E2 on dental plaque accumulation using a 4-day plaque accumulation model. This single-blind, single-center, 3-way crossover randomized controlled trial includes 32 adult subjects aged 18 to 65 years. The study compares three treatment groups: MIIP-E2 gum (experimental), placebo gum without MIIP-E2 (negative control), and no gum (control). The purpose is to assess how these different regimens influence plaque buildup in the mouth over short periods. Each subject undergoes three treatment periods lasting 4 days each, separated by about 10-day washout intervals. During each treatment period, participants refrain from oral hygiene and use only the assigned gum product three times daily for 10 minutes after meals by chewing on each side of the mouth for one minute before free chewing. The no-gum group does not use any gum. Subjects record gum usage and any related events in a diary to monitor compliance. Before starting treatments, eligible subjects receive dental prophylaxis and baseline assessments, including plaque removal and oral examinations. Throughout the study, participants attend visits for oral examinations, plaque assessments using a plaque index, saliva collection, and intraoral photographs. At the end of each treatment period, plaque accumulation is evaluated after rinsing with a disclosing solution. Researchers measure dental plaque levels as the primary outcome. The study also includes monitoring for adherence, safety, and the overall oral condition during treatment and washout periods. The total participation includes three 4-day treatment phases with assessments before, during, and after each phase.

Researchers are investigating whether the supplement 5-hydroxytryptophan (5HTP), derived from the plant Griffonia Simplifolia, can improve lung function and reduce anxiety symptoms in children with mild to moderate asthma who have allergic sensitization. This Phase 2 study aims to determine if 5HTP reduces allergic lung responses and blood eosinophil counts, improves lung inflammation, and influences hormone levels, while monitoring changes in anxiety and depression scores. Participants will take either 5HTP or a placebo in a double-blind, randomized crossover design. Each treatment period lasts 28 days, followed by a 3-week washout period before switching to the other treatment. This means each child will receive both 5HTP and placebo at different times during the study. Over about 12 weeks, participants will attend five study visits. Their lung function will be assessed using pulmonary function tests measuring Forced Expiratory Volume in one second (FEV1). Researchers will also monitor blood and nasal fluid eosinophil levels, hormone changes, and anxiety/depression symptoms using questionnaires. The study includes safety monitoring and ensures participants can comply with all procedures throughout the study duration.

Researchers are assessing the safety and effects of Ritlecitinib, a study medicine, for treating hidradenitis suppurativa (HS), a condition causing long-lasting, painful red skin lumps. This phase 2 study focuses on adults with moderate to severe HS who have not responded well to or cannot tolerate antibiotics. The goal is to compare experiences and outcomes between those receiving Ritlecitinib and those receiving a placebo. Participants will be randomly assigned to take either Ritlecitinib or a placebo pill once daily at home. The treatment involves an initial loading dose of Ritlecitinib for 8 weeks, followed by an 8-week maintenance dose, totaling 16 weeks of treatment. The placebo group will receive a matching pill with no active medicine. Over approximately 24 weeks, including screening and follow-up, participants will attend around 10 clinic visits for health evaluations, including physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. They will also track their medication intake and HS symptoms daily using an electronic diary on a mobile phone. The study will measure how many patients achieve at least a 50% improvement in HS symptoms by week 16 to evaluate treatment response and safety.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the effectiveness of three experimental denture adhesive creams compared to using no adhesive in people who wear full maxillary dentures. The study aims to measure how well these adhesives improve denture hold over a period of 13 hours by assessing the maximum bite force before the denture becomes dislodged. This is a controlled, randomized, single-blind clinical trial involving full maxillary denture wearers. Participants will experience five different treatment periods in a cross-over design, including the use of three experimental denture adhesive creams, a commercially available denture adhesive cream called Poligrip Power Hold + Seal, and a no-adhesive control. Each participant will test each treatment to compare the maximum maxillary bite force across these conditions. The adhesives are applied as creams to the dentures to evaluate their holding effectiveness. During the study, participants will have their maximum bite force measured over 13 hours to determine denture retention. Researchers will monitor safety and compliance throughout the study. Up to 60 participants will be randomized to ensure at least 54 complete all study periods. Assessments will include oral examinations and bite force measurements at scheduled visits to evaluate the adhesives' performance and participant wellbeing.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of a new treatment called NXT007 compared to emicizumab prophylaxis in people aged 12 years and older with severe or moderate congenital hemophilia A without factor VIII inhibitors, as well as those with hemophilia A of any severity who have factor VIII inhibitors. This phase III clinical trial aims to better understand how well these treatments work and how safe they are for managing hemophilia A. Participants will receive either NXT007 or emicizumab as prophylactic treatments. NXT007 is given by subcutaneous injection using a combined drug-device product, while emicizumab is administered subcutaneously using a vial and syringe. The study compares these two methods of treatment over a main study treatment period starting from the second month until at least seven months after the first dose. During the study, researchers will monitor how often treated bleeding episodes occur, measured as the Annualized Bleed Rate (ABR). Participants' medical histories, including previous treatments and bleeding episodes, will be carefully documented. Safety and treatment effects will be closely observed throughout the study to evaluate the overall impact of both treatments on the participants' condition.