Overland Park

Researchers are studying the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition causing long-lasting painful red skin lumps. The study focuses on participants who have not responded well to antibiotics or could not tolerate them. This is a phase 2, randomized, double-blind, placebo-controlled trial to evaluate how well Ritlecitinib works compared to a placebo. Participants will be randomly assigned to receive either Ritlecitinib or a placebo pill that looks the same but contains no medicine. Those in the treatment group will take an oral loading dose once daily for 8 weeks, followed by a maintenance dose once daily for another 8 weeks. The placebo group will receive matching placebo pills on the same schedule. The total study duration is about 16 weeks. During the study, participants will attend about 10 clinic visits including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until week 16. At each visit, health status will be checked through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also use an electronic diary on their mobile phones to record daily medication intake and HS symptoms. The main measurement is the proportion of participants achieving a 50 reduction in HS symptoms by week 16. Safety and other symptom improvements will also be monitored.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

This trial investigates ATI-1013, a drug being studied in healthy adult cigarette smokers to understand its safety, how long it stays in the body, whether it causes an immune response, and its effects on nicotine levels. The study compares ATI-1013 to a placebo to evaluate safety and how the drug interacts with nicotine. It is a first-in-human, phase 1 clinical trial conducted by Antidote Therapeutics, Inc. Participants receive one intravenous infusion of ATI-1013 at one of three escalating doses 0.2 g, 0.8 g, or 3.2 g or a placebo. The study uses a randomized, double-blind design with a 41 ratio favoring ATI-1013 in each dose group. The trial includes a screening period, a dosing day with at least 48 hours of in-clinic observation, and follow-up visits on Days 7, 21, 42, 56, and 84, plus telephone check-ins on Days 5, 14, 28, and 70. Participants keep a diary of their cigarette use and smoking habits. Researchers monitor adverse events, immune responses, and drug levels in the blood over 84 days. They also track nicotine-related physiological responses such as skin temperature, heart rate, blood pressure, and withdrawal symptoms, along with subjective effects of nicotine. Safety and drug behavior in the body are key outcomes throughout the study period.

Researchers are evaluating the effects of pelacarsen TQJ230, given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoproteina levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoproteina levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants well-being during the entire study period.

Researchers are investigating how the drug NNC0662-0419 works together with birth control pills and affects stomach emptying in women who cannot become pregnant and have overweight or obesity. This phase 1 study aims to find out if NNC0662-0419 is safe and how it interacts with other medicines, including a birth control pill called Altavera and a mild painkiller, acetaminophen. The study includes women aged 18 to 64 years who weigh at least 60 kilograms and are generally healthy except for their weight condition. Participants will receive weekly injections of NNC0662-0419 using a pen injector over the treatment period. They will also take the oral contraceptive Altavera under supervision and a single dose of acetaminophen with a standardized meal during the treatment. The study measures how these medicines move through the body, focusing on the levels of the birth control hormones and how the stomach empties after eating. During the study, participants will undergo blood tests to measure the levels of the hormones ethinylestradiol and levonorgestrel and the painkiller acetaminophen at specific times after dosing. Researchers will monitor the participants health through physical exams, vital signs, heart tests, and lab tests. The study will last through the treatment period with assessments before and after dosing to ensure safety and collect data on how the drugs are processed by the body.

Researchers are studying the safety and effectiveness of UBT251 for people living with overweight or obesity. This clinical trial is a phase 2 study that compares different doses of UBT251 against a placebo, which contains no active medicine. The goal is to understand how UBT251 affects body weight and tolerability in adults with these conditions. Participants will be randomly assigned to receive various doses of UBT251 or a placebo, all given as injections under the skin of the abdomen. The study includes multiple parts where participants receive different dose levels, with some receiving a single dose and others multiple doses. Placebo injections are designed to look like UBT251 to maintain study blinding. During the trial, participants will be monitored for treatment-emergent adverse events and changes in body weight over several weeks. Blood samples will be taken to measure UBT251 levels in the body. The study involves regular visits for assessments including physical exams, vital signs, and lab tests, extending up to 33 weeks. Researchers will track safety, tolerability, and how the drug moves through the body to evaluate outcomes.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating a drug called SEA-CD70, alone and combined with azacitidine, to assess its safety and potential effects in adults with myelodysplastic syndrome MDS and acute myeloid leukemia AML. This phase 1, open-label study aims to find appropriate dosing and understand side effects and antitumor activity in participants with relapsed or refractory disease as well as previously untreated higher-risk cases. The trial is sponsored by Seagen, a subsidiary of Pfizer, and includes several parts to address different patient groups and treatment combinations. The study consists of seven parts dose escalation and expansion of SEA-CD70 monotherapy for relapsedrefractory MDS and AML dose-finding and expansion of SEA-CD70 combined with azacitidine for relapsedrefractory and untreated higher-risk MDS or MDSAML and dose-finding of SEA-CD70 with azacitidine and venetoclax in untreated AML patients unfit for standard chemotherapy. SEA-CD70 is given intravenously on Days 1 and 15 of each treatment cycle, azacitidine is given either subcutaneously or intravenously on Days 1 through 7, and venetoclax is taken orally daily with dose ramping. Participants will undergo safety and tolerability assessments, laboratory tests, and pharmacokinetic analyses through approximately two years after the last dose. Researchers will monitor adverse events, dose-limiting toxicities, and laboratory abnormalities. Secondary measures include response rates, remission durations, survival rates, and drug concentration levels. The study evaluates how well participants tolerate the treatments and examines the drugs effects on disease progression over up to four years.