Nelson

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are studying the effects of a drug called KAI-9531, given as a subcutaneous injection once a week, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if KAI-9531 is better than a placebo at reducing body weight and lowering hemoglobin A1c (HbA1c), a measure of blood sugar control, over a 76-week period. This Phase 3, randomized, double-blind, placebo-controlled trial focuses on those who have tried and struggled to lose weight through diet and exercise. Participants receive either KAI-9531 or a placebo through weekly injections under the skin. The study compares doses 3 and 4 of KAI-9531 against placebo to evaluate changes in body weight and HbA1c from the start of the study to week 76. The treatment is monitored closely throughout the trial to assess effectiveness and safety. During the study, participants will have their body weight and HbA1c measured at baseline and again at week 76 to observe changes. Researchers will also monitor safety and any side effects. The overall participation includes regular follow-ups and assessments to track progress and health status over the study duration.

Researchers are evaluating the effects of KAI-9531, a weekly subcutaneous injection, on body weight changes in adults living with obesity or overweight who also have weight-related health conditions but do not have diabetes. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare KAI-9531 against a placebo to understand its impact on weight reduction over time. Participants will receive either KAI-9531 or a placebo as a subcutaneous injection once a week. The study focuses on the percent change in body weight from the start of treatment to week 76. Both the treatment and placebo groups will be monitored throughout the trial to assess efficacy and safety. During the study, participants will have their body weight measured at baseline and week 76 to track changes. Researchers will also monitor safety and other health factors throughout the trial. The total participation duration includes the treatment period up to week 76, with assessments to evaluate the impact of the injections on weight and related health conditions.

Researchers are evaluating the safety and effectiveness of OD-07656 in adults with moderately to severely active ulcerative colitis (UC). This Phase 2a study also aims to assess whether OD-07656 can improve the benefits of vedolizumab, a standard treatment, when given afterward. Participants must have a confirmed diagnosis of UC and have not responded adequately or tolerated previous UC therapies. Participants will receive OD-07656 as the experimental treatment. After completing treatment with OD-07656, some will receive vedolizumab to evaluate combined therapeutic effects. The study design includes an open-label and randomized approach to assess these treatments in a controlled manner. During the study, researchers will monitor changes in the 3-component modified Mayo Clinic Score to measure disease activity from the start to 12 weeks after treatment. They will also track any treatment-emergent adverse events and reasons for stopping treatment during this period. The trial involves regular assessments to ensure safety and evaluate the ongoing response to therapy over the 12-week timeframe.