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Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Researchers are evaluating the safety and immune response of a second dose of the RSVpreF vaccine in pregnant women during later pregnancies. The study also aims to understand how long the protection lasts from a single dose given during a previous pregnancy by examining blood samples from nonpregnant participants who had the vaccine before. This Phase 3 trial involves pregnant participants and their unborn babies, as well as nonpregnant participants previously vaccinated. Pregnant participants are divided into two groups one group who previously received RSVpreF in a Pfizer trial will get a second dose, and another group will be randomly assigned to receive either RSVpreF or a placebo if no prior antibody data exists. Infants born to these participants will be followed for six months to monitor safety and antibody levels. Nonpregnant participants who received RSVpreF in an earlier trial will provide blood samples to assess the durability of their immune response without receiving additional vaccine doses. Participants will undergo safety monitoring including tracking local and systemic reactions, adverse events, and serious events during pregnancy and after birth for infants. Blood tests will measure neutralizing antibodies against RSV types A and B at birth, 3 months, and 6 months. The study includes consent procedures for both pregnant participants and infants, and nonpregnant participants will have scheduled visits for blood sample collection. The total study duration extends through infant follow-up and ongoing immune response assessments.

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with Major Depressive Disorder MDD. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner compared to placebo in adults with moderate-to-severe MDD. Participants are adults aged 18 to 74 years with a current major depressive episode lasting between 6 weeks and 24 months. Participants will be randomly assigned to receive either azetukalner 20 mg or placebo, both taken orally once daily with food, preferably with the evening meal, for 6 weeks. The study uses a parallel design and includes a placebo comparator. Azetukalner and placebo are administered as daily oral doses over the treatment period. During the study, participants will undergo assessments including the Hamilton Depression Rating Scale HAMD-17 at baseline, Week 1, and Week 6, the Snaith-Hamilton Pleasure Scale SHAPS, and the Clinical Global Impression of Severity CGI-S score at Week 6. Safety and tolerability are monitored from screening through 8 weeks after the final dose. The primary outcome is the change from baseline in HAMD-17 at Week 6. Total participation may last several months, including screening, treatment, and follow-up periods.

Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction HFpEF, a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drugs safety and biological effects.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that targets multiple inflammatory cytokines, in adults with moderate to severe hidradenitis suppurativa HS that is not well controlled by systemic antibiotics. This double-blind, placebo-controlled study involves participants aged 18 to 75 years and aims to understand how well BFB759 works compared to a placebo over approximately 36 to 40 weeks. Participants will be randomly assigned to one of several groups. Some will receive a loading dose of BFB759 followed by either a high or mid maintenance dose every two weeks through Week 14. Others will receive a placebo every two weeks for 14 weeks, then, if still enrolled, be re-randomized to receive either a low or mid dose of BFB759 every two weeks from Week 16 through Week 30. This design allows comparison of different dosing regimens and the placebo effect. During the study, participants will attend about 22 visits over 21 months to monitor safety and effectiveness. Researchers will measure clinical activity using scales such as HiSCR50, the International Hidradenitis Suppurativa Severity Score System IHS4, Skin Pain Numerical Rating Scale, and the Hidradenitis Suppurativa-Investigator Global Assessment HS-IGA. Participants are expected to follow study instructions carefully, attend regular visits, and avoid certain medications. The primary outcomes focus on efficacy at Weeks 16 and 32, with ongoing safety assessments throughout the study.

Researchers are evaluating the characteristics and outcomes of individuals with asthma across different levels of disease severity in routine clinical practice. The study aims to describe participants sociodemographic and clinical features, treatment patterns, disease burden, biomarkers, and both asthma-specific and general quality of life. This research includes both a cross-sectional analysis and a prospective follow-up to observe changes in disease progression over time. The study involves participants receiving standard asthma care, including treatment with varying doses of inhaled corticosteroids andor biologic therapies. Participants are grouped based on asthma control levels and biomarker status. The first part of the study collects baseline data cross-sectionally, while the second part follows participants prospectively to assess differences in asthma symptom control, treatment use, lung function, and comorbidities over a two-year period. Participants will be involved in scheduled data collection including patient and physician-reported outcomes, lung function tests, blood samples, and questionnaires assessing quality of life and symptom control. The study monitors treatment utilization and health resource use from the prior year and during follow-up visits at one and two years. The total participation period spans up to two years with ongoing assessment of disease characteristics and outcomes.

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Researchers are studying the effectiveness of NAV-240 compared to a placebo in adults with moderate-to-severe Hidradenitis Suppurativa HS. The main goal is to see how many participants achieve at least a 75% reduction in inflamed skin bumps by Week 16 without an increase in abscesses or draining tunnels. This phase 2a study involves participants who have stable HS and have not responded well to antibiotics. Participants will be randomly assigned to receive one of two doses of NAV-240 or a placebo through intravenous infusions. They will receive the assigned treatment during the study period and attend up to 9 clinic visits over 22 weeks for checkups and tests. Participants will also complete a daily diary to record their skin pain. The study includes monitoring skin lesions and other skin-related outcomes over 16 weeks. During the study, participants will have regular assessments, including lesion counts and skin pain evaluations. Researchers will measure outcomes such as the clinical response of HS, skin pain improvement, quality of life changes, and flare occurrences. Safety and treatment effects will be monitored through clinic visits and participant diaries. The total study duration is about 22 weeks, with the main results assessed at Week 16.