Pinetown

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of different doses of ELV001 in treating active rheumatoid arthritis (RA) in patients who have not responded well to methotrexate and tumor necrosis factor inhibitors. The trial plans to enroll around 180 to 220 adult participants aged 18 to 75 years with active RA meeting specific clinical criteria. The study aims to measure changes in disease activity using the DAS28-C-reactive protein score from baseline to week 12. The study includes four groups receiving placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. Participants receive treatment for 24 weeks, starting with a 4-week screening period. The first 12 weeks are double-blind and placebo-controlled, followed by a treatment extension from weeks 12 to 24 where some participants may have their ELV001 dose adjusted. After treatment, a 4-week safety follow-up period monitors participants for any adverse effects. Participants will have regular assessments including blood tests, joint evaluations, and monitoring of disease activity scores throughout the study. Researchers will track medication adherence and safety through physical exams, laboratory tests, and ECGs. The primary outcome focuses on improvement in disease activity at week 12. The total study duration for each participant is about 32 weeks from screening to the end-of-study visit.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.