Avon Park

Systemic lupus erythematosus SLE, Sjogrens disease SjD, and rheumatoid arthritis RA are chronic autoimmune diseases characterized by B cell hyperactivity or immune system attacks on the bodys own tissues. This research aims to assess the pharmacokinetics, safety, and effectiveness of ABBV-319, an investigational drug that may reduce B cell activity in adults with these conditions. The trial enrolls about 48 adults with SLE, SjD, or RA at multiple sites worldwide. Participants are assigned to one of eight groups based on their condition and receive two intravenous doses of ABBV-319 spaced 21 days apart. Each group receives a different dose tailored to their specific disease SLE, SjD, or RA. The study follows participants for up to 343 days after dosing to monitor effects and safety. During the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to evaluate side effects and treatment impact. Researchers measure adverse events, changes in B cells in blood and tissue, drug concentration in plasma, and the presence of anti-drug antibodies. Monitoring continues for up to approximately 400 days to gather comprehensive safety and efficacy data.

Researchers are evaluating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis RA, a chronic inflammatory condition causing joint pain, stiffness, swelling, and loss of function. This Phase 2 study involves three substudies focusing on different drug treatments to assess their effectiveness and safety for participants who have not responded to one or two prior biologic or targeted synthetic DMARD therapies. Participants will be randomly assigned to receive one of several treatments lutikizumab alone, ravagalimab alone, a combination of lutikizumab and ravagalimab, or matching placebos. These drugs are given by subcutaneous injection. The study involves regular visits at hospitals or clinics where participants receive the assigned treatment and are monitored closely. The treatment period and detailed dosing schedules are part of the studys design. During the trial, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects, side effects, and disease activity. The main outcomes measured include the percentage of participants achieving a 50% improvement according to the American College of Rheumatology criteria by Week 12 and the number of adverse events up to approximately Week 22. Participants will attend regular visits for evaluations throughout the study period, which is expected to complete by November 2027.

Researchers are evaluating sonelokimab in adults with active psoriatic arthritis who have not had adequate results or could not tolerate prior anti-tumor necrosis factor TNF alpha therapy. This Phase 3, multicenter, randomized, double-blind study compares the safety and effectiveness of two doses of sonelokimab against placebo and an active reference treatment called risankizumab. Participants are randomly assigned to one of four groups one receiving sonelokimab dose 1, another receiving sonelokimab dose 2, one receiving placebo, and one receiving risankizumab. Those in the sonelokimab groups receive four initial subcutaneous doses as induction, then maintenance doses every four weeks starting at Week 8. The placebo and risankizumab groups receive their respective treatments subcutaneously according to the study protocol. During the study, participants will undergo assessments of joint tenderness and swelling, skin psoriasis activity, physical function, and quality of life at Week 16. Researchers will monitor response rates based on improvement criteria such as the American College of Rheumatology 50% improvement ACR50. Safety and tolerability will also be followed throughout the trial, which is expected to complete by January 2027.

Researchers are evaluating targeted therapies for adult participants with active psoriatic arthritis, a condition where the immune system attacks healthy cells causing joint pain, stiffness, and swelling. This phase 2 study aims to assess the effectiveness and safety of risankizumab and lutikizumab, either alone or combined, in improving disease symptoms. The trial will include about 120 participants worldwide and focuses on measuring changes in disease activity and side effects. Participants will be randomly assigned to one of three treatment groups risankizumab alone, lutikizumab alone with doses every other week, or a combination of both drugs following the monotherapy dosing schedules. All treatments are given by subcutaneous injection. The study includes regular visits to clinics or hospitals where treatments are administered and monitored. During the study, participants will undergo medical evaluations including joint assessments, blood tests, and questionnaires to track symptoms and side effects. The main outcomes measured include the percentage of participants achieving a 50% improvement in arthritis symptoms by week 16 and the number of adverse events up to week 52. Participants will attend scheduled visits throughout the study, and safety will be closely monitored until the study ends in 2028.