North Miami Beach

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.

Researchers are evaluating the safety, tolerability, and immune response duration of a second dose of the RSVpreF vaccine given during later pregnancies. The study also examines how long immunity lasts from a single dose given during a previous pregnancy by analyzing blood samples from nonpregnant participants who had the vaccine before. This is a Phase 3 trial focused on pregnant women and their babies as well as nonpregnant women previously vaccinated. Pregnant participants are grouped into Cohort 1, who previously received RSVpreF in a Pfizer trial and will get a second dose, and Cohort 2, who received RSVpreF previously via commercial or trial means and will be randomly given either RSVpreF or placebo. Both groups will be monitored for safety and immune response. Cohort 3 includes nonpregnant women who had RSVpreF before and will provide blood samples to check how long protection lasts, without receiving further vaccination. Participants will undergo safety monitoring during pregnancy and after birth. Infants will be followed for six months to assess safety and antibody levels. Blood tests will measure immune response, including neutralizing antibodies at birth. The study tracks local and systemic reactions, adverse events, serious adverse events, and new medical conditions in both pregnant participants and their infants over various timeframes throughout the study.

This research aims to evaluate the effectiveness, safety, and tolerability of two doses of remibrutinib compared to placebo in people aged 12 years and older with moderate to severe hidradenitis suppurativa, a chronic skin condition. The study is a phase 3 clinical trial involving participants with a diagnosis lasting at least six months and active symptoms in multiple body areas. The purpose is to determine how well remibrutinib works and how safe and tolerable it is for this condition. The trial lasts a total of 76 weeks and includes several parts: a screening period of up to 4 weeks, a first treatment period of 16 weeks where participants receive either remibrutinib Dose A, Dose B, or placebo in a double-blind manner, followed by a second treatment period lasting 52 weeks during which all participants receive remibrutinib doses. After treatment, there is a 4-week safety follow-up without treatment. Participants stopping treatment early are encouraged to continue in the study and complete the safety follow-up. During the study, participants will be regularly monitored for their response to treatment, including the proportion who achieve a clinical response measure called HiSCR50 at Week 16. Assessments will include physical exams and safety checks throughout the treatment periods and follow-up. The study seeks to gather detailed information on how remibrutinib affects the severity of hidradenitis suppurativa and participants' overall health during and after treatment.

Researchers are evaluating azetukalner as a monotherapy in adults diagnosed with moderate-to-severe 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. Participants must be adults between 18 and 74 years old, experiencing a current major depressive episode confirmed by standard diagnostic criteria and lasting between 6 weeks and 24 months. Participants are randomly assigned to receive either azetukalner 20 mg or a placebo, both taken orally once daily with food (preferably with the evening meal) for 6 weeks. The study compares these two groups to determine the impact of azetukalner on depressive symptoms. The trial maintains double-blinding to ensure unbiased assessment of outcomes. During the study, participants undergo regular assessments including evaluations of depressive symptoms using the Hamilton Depression Rating Scale (HAMD-17) at baseline and at Week 6. Safety and tolerability are monitored throughout the treatment period. The total participation time corresponds to the 6-week treatment phase, during which symptom changes and adverse events are closely observed.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in adults aged 50 years and older who have Heart Failure with Preserved Ejection Fraction (HFpEF). This phase 1 trial focuses on participants diagnosed according to established criteria and classified as NYHA Functional Class II or III, with specific heart function and biomarker thresholds. The study aims to better understand how VS-041 works in this population by monitoring heart-related biomarkers and side effects over time. Participants will receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The study treatment lasts for 28 days, during which researchers will track changes in specific blood biomarkers such as NordicPRO-C6, endotrophin, and NT-proBNP. These biomarkers help measure the heart condition and response to the treatment. The trial includes careful dosing and monitoring to assess safety and tolerability. During the study, participants will undergo regular assessments to check for any treatment-emergent adverse events and changes in biomarker levels from baseline up to day 28. The evaluations may include blood tests and clinical exams to monitor heart function and overall health. Participants are required to maintain stable doses of their usual heart failure medications and comply with trial procedures for the entire duration. The total participation period is focused on the 28-day treatment and observation window.

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

This research aims to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. The study is a Phase 2 and Phase 3, dose-ranging, randomized, double-blind, placebo-controlled trial comparing BFB759, a biological treatment that blocks multiple pro-inflammatory cytokines, to a placebo. Participants have had hidradenitis suppurativa for at least one year and have disease that is not well controlled by antibiotics. Participants receive either BFB759 or a placebo in a blinded manner over the course of the study. The study lasts approximately 36 to 40 weeks during which the treatment's effects and safety are assessed. The trial evaluates the drug's impact on hidradenitis suppurativa symptoms and monitors for any adverse reactions. Throughout the study, participants attend regular visits to assess their condition and safety. Researchers monitor the efficacy of BFB759 from the start to Week 16 and Week 32. Participants are asked to follow study instructions carefully, attend scheduled visits, and avoid certain other medications. The trial includes adults aged 18 to 75 years and collects data on treatment effectiveness and safety over the full study period.

This research aims to evaluate the antiviral effects of S-337395 compared with placebo in nonhospitalized adult participants who have symptomatic respiratory syncytial virus (RSV) infection and are at high risk of progressing to severe disease. The study focuses on adults with recent onset of RSV symptoms and important risk factors such as advanced age or chronic lung or cardiovascular disease. It is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial to assess safety, tolerability, and efficacy. Participants will receive either S-337395 or a matching placebo according to a specified dosing schedule. The treatment begins within 72 hours of RSV symptom onset. The study measures changes in RSV viral RNA load from baseline to Days 2, 4, and 6 using nasopharyngeal swabs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) tests to monitor antiviral effects. During the study, participants will be monitored for safety and effectiveness through viral load testing at multiple time points. Medical history, physical exams, vital signs, and ECGs are conducted to ensure stability aside from RSV symptoms. The study also tracks symptoms and any adverse events to evaluate treatment tolerability. Total participation includes screening and follow-up assessments as outlined by the study protocol.