A Phase I Dose Escalation Study of Bispecific Antibodies in Adult Patients with Lupus Nephritis

The primary objective of this study is to evaluate the dose escalation of bispecific antibodies in adult patients diagnosed with lupus nephritis. This investigation is clinically significant for determining the tolerated dose levels and the pharmacological profile of the investigational product in this specific patient population. There are no secondary objectives reported.

The study population consists of 41 patients diagnosed with lupus nephritis. The cohort includes both male and female participants. The subjects fall within the age range categorized by code 3. The sponsor did not provide additional information regarding lifestyle considerations, selection processes, or specific inclusion and exclusion criteria.

This Phase 3, dose escalation study is designed to evaluate the effects of bispecific antibodies in adult patients diagnosed with lupus nephritis. The clinical trial methodology involves a structured sequence of study visits beginning with a screening visit to determine eligibility. Following enrollment, participants will undergo periodic follow-up visits to monitor safety and therapeutic response. The protocol concludes with an end-of-study visit. The total duration of the study is projected to extend from January 2026 to October 2028. Participation may be subject to early termination based on predefined clinical conditions or safety criteria.

The efficacy assessment in this Phase 3 clinical trial focuses on the management of Lupus Nephritis. Information regarding specific endpoints, measurement schedules, or analytical tools is not provided.