In short
Clinical trials are studying Zetomipzomib in people with active lupus nephritis, a kidney problem linked to autoimmune disease. These studies look at whether it is safe and whether it helps improve disease control. The main goal is to see how well it works in adults with Class III, IV, or V lupus nephritis.
Key points
- Clinical trials of Zetomipzomib are studying active lupus nephritis, which is a lupus-related kidney disease. The main trial in the source data is a Phase 2 interventional study. It included patients with active Class III or IV lupus nephritis, with or without Class V, as well as patients with pure Class V lupus nephritis. The study planned to enroll 247 people and was completed. The main endpoint was complete renal response at Week 37, which measures how well the kidneys improved.
Trial overview
The source data describes one clinical trial of Zetomipzomib, also listed as KZR-616, in patients with active lupus nephritis. The study was called PALIZADE and was designed to look at both efficacy and safety.
Who was studied
This trial focused on people with active lupus nephritis, which is kidney inflammation linked to an autoimmune disease. The study included patients with active Class III or IV lupus nephritis, with or without Class V, and also patients with pure Class V lupus nephritis.
These class names describe the pattern of kidney disease seen in lupus nephritis. In simple terms, the study looked at people with specific forms of lupus-related kidney damage, including both mixed and single-class disease.
What the study measured
The main outcome, or primary efficacy endpoint, was the proportion of patients who achieved CRR at Week 37. CRR means complete renal response, which is a study term for a strong kidney improvement.
This endpoint tells researchers how many patients reached the target kidney response by the planned time point. The trial summary also states that the study was designed to evaluate both efficacy and safety.
Trial phase and size
The trial was a Phase 2 study. Phase 2 studies usually explore whether a treatment shows early benefit while continuing to collect safety information.
The planned enrollment was 247 patients. This number shows the study was large enough to assess the treatment in a meaningful group of patients with lupus nephritis.
Trial status and design
The trial status was Completed. It was an interventional study, which means researchers gave a treatment and then measured the results.
The source data lists Zetomipzomib as a drug given by subcutaneous injection in the study. The trial also included other treatments in the study record, but the source summary mainly highlights Zetomipzomib as the investigational treatment for active lupus nephritis.
Important patient terms
- Lupus nephritis means lupus is affecting the kidneys and causing inflammation.
- Class III, IV, or V are labels for different kidney patterns seen in lupus nephritis.
- Efficacy means how well a treatment works in the trial.
- Safety means how well people tolerate the treatment in the study.
- Week 37 is the time point when the main result was checked.