Papar

Researchers are evaluating how well JNJ-78934804 works and how safe it is compared to guselkumab in participants with moderately to severely active Crohns disease, a long-term and progressive condition affecting the intestine. This Phase 3 trial aims to assess clinical remission and endoscopic remission at Week 48, focusing on treatment efficacy and safety. Participants are randomly assigned to receive either JNJ-78934804 or guselkumab. Both treatments involve induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting at Week 12. Participants meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, with maintenance doses continuing every 4 weeks from Week 28. Those completing the double-blind phase at Week 48 may enter a long-term extension phase if the investigator believes they may benefit. During the study, participants will be monitored for clinical and endoscopic remission, deep remission, corticosteroid-free remission, and patient-reported outcomes up to Week 48. Researchers will also track adverse events for up to approximately three years. Assessments include symptom scores, endoscopy reviews, and quality-of-life questionnaires to evaluate the treatments effects and safety throughout the trial.

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.