Nadarzyn

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are evaluating the effectiveness of icotrokinra JNJ-77242113 compared to a placebo in adults with active psoriatic arthritis PsA, including those who have and have not previously used biologic treatments. The study aims to assess how well icotrokinra reduces the signs and symptoms of PsA, focusing on improvements measured by the American College of Rheumatology ACR 20 response at Week 16. Participants are randomly assigned to receive one of two doses of icotrokinra or a matching placebo. Those initially receiving placebo will switch to one of the icotrokinra doses at Week 16. Participants who continue without discontinuing the study drug are eligible to enter a long-term extension phase, where they keep receiving their assigned icotrokinra dose. The treatment period involves regular monitoring and assessment of psoriatic arthritis symptoms. Throughout the study, participants will undergo various assessments, including evaluations of joint swelling and tenderness, skin psoriasis severity, fatigue, physical function, and quality of life. Laboratory tests such as C-reactive protein levels will be measured to monitor inflammation. Researchers will track responses using validated scales like the Psoriatic Area and Severity Index PASI and Investigator Global Assessment IGA. The total duration includes treatment and follow-up visits up to Week 16, with options for extended treatment in the long-term extension phase.

Researchers are studying the drug JNJ-88545223 to see how well it works compared with a placebo in adults who have active psoriatic arthritis PsA. This study aims to determine if JNJ-88545223 can reduce the signs and symptoms of PsA and improve the health of joints and skin. The trial is a randomized, double-blind phase 2b study designed to evaluate different doses of the drug. Participants will be randomly assigned to receive one of four treatments from Week 0 to Week 16 placebo, or one of three doses of JNJ-88545223. Each group will receive their assigned treatment under blinded conditions to compare the effects. The study focuses on evaluating the efficacy and safety of these doses over the 16-week treatment period. During the study, participants will undergo regular assessments to measure treatment effects, including the American College of Rheumatology ACR 50 response at Week 16 as the primary outcome. Additional evaluations include skin severity indexes PASI responses, physical function questionnaires, and quality of life surveys. Safety and symptoms will be monitored throughout the trial, which lasts approximately 16 weeks for each participant.

Researchers are investigating the treatment outcomes of subcutaneous anifrolumab 120 mg given once weekly as add-on therapy to antimalarials, with or without glucocorticoids GCs, in patients with systemic lupus erythematosus SLE who have not previously received immunosuppressants or biologic therapies and are not in low disease activity status at enrollment. This Phase 3, multinational, open-label study aims to better understand remission rates, including DORIS remission, and the ability to taper and withdraw chronic GCs in this patient group. Participants will receive anifrolumab administered subcutaneously once weekly for 52 weeks using an autoinjector pen. The study includes a screening period of up to 35 days before treatment starts. For patients on higher doses of GCs at baseline, a structured tapering protocol will be followed from week 5 to week 40, aiming to reduce GC doses to 5 mgday and potentially withdraw GCs completely after sustained remission. After week 40, no further GC dose reductions will occur. An additional 12-week safety follow-up is planned for participants who discontinue anifrolumab after week 52. During the study, participants will undergo regular assessments including clinical evaluations, quality of life and fatigue questionnaires, and laboratory tests to monitor disease activity and remission status. Researchers will measure outcomes such as attainment and duration of DORIS remission, low disease activity, flare incidence, and changes in GC use. Safety will be monitored throughout treatment and in the follow-up period. The total study duration for participants is approximately 69 weeks, including screening, treatment, and safety follow-up.

Researchers are evaluating the impact of the Accu-Chek SmartGuide continuous glucose monitoring CGM system compared with traditional self-monitoring of blood glucose SMBG in adults with Type 1 or insulin-dependent Type 2 diabetes who use multiple daily insulin injections. This open-label, randomized, multi-center clinical device study aims to see how the CGM system affects the time participants blood glucose levels stay within the target range of 70-180 mgdL. The study is sponsored by Hoffmann-La Roche and focuses on measuring blood glucose control improvements. Participants are assigned to one of two groups one uses the Accu-Chek SmartGuide CGM solution, which includes a sensor applicator and smartphone apps providing real-time glucose data and analysis the other group continues standard care with SMBG devices while wearing a blinded CGM sensor intermittently during assessment periods. The blinded sensors record data without providing feedback to participants. The study includes baseline, assessment periods A, B, and C occurring over several weeks to compare glucose control over time. During the study, participants will have their blood glucose monitored continuously or through SMBG devices, complete questionnaires on diabetes distress and fear of hypoglycemia, and have laboratory tests including HbA1c at multiple time points. Researchers will track various glucose metrics such as time in range, hypoglycemia events, and glycemic variability. The study duration extends through several assessment periods up to approximately 26 weeks, with ongoing evaluations to assess the usability and impact of the CGM system on diabetes management.

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.