Pinetown

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.