NCT04810754

An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus

A Monocenter, Open Label Study to Evaluate the Safety and Efficacy of Daratumumab in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a monocenter, open-label Phase II trial for refractory SLE patients currently on stable background immunosuppressive therapy. Treatment in this trial will be daratumumab weekly for a period of 8 weeks. This study will enroll 10 patients.

Detailed description

This clinical trial "DARALUP" is designed to evaluate the efficacy and safety of daratumumab, a monoclonal antibody directed against CD38, in patients with systemic lupus erythematosus (SLE). This is a monocenter, open-label Phase II trial recruting SLE patients with clinical and serologic activity despite state-of-the-art immunosuppressive therapy. Treatment in this study will be Weekly daratumumab injections over a period of 8 weeks. This study will enroll 10 patients. SLE is a sometimes severe, generalized autoimmune disease with few approved therapies to date. Therefore, the planned study offers an opportunity to identify a new, targeted therapeutic approach. Daratumumab has been studied in multiple Phase III clinical trials in patients with relapsing multiple myeloma, a plasma cell malignancy, where it demonstrated efficacy with an acceptable safety profile and has been approved since 2016 under the trade name Darzalex®. The aim is to investigate whether daratumumab provides clinically significant efficacy in SLE, another disease in which plasma cells have been shown to play a pathogenic role. Previous experience by the sponsor of this trial with the use of daratumumab in two patients with SLE suggests that one cycle of 4 weekly infusions with 16 mg/kg daratumumab was associated with a significant serologic and clinical response. In this study, a dosing regimen of 2 cycles of Darzalex is planned, with one cycle containing 4 Weekly injections. Based on the previously reported efficacy under anti-CD38 therapy, this human monoclonal antibody appears suitable for the therapy of SLE and will be investigated in this study.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Daratumumab Injection	1800 mg per injection; 8 consecutive injections once a week; subcutaneous application in abdomen

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-03-31
• Completion: 2023-12-31
• First posted: 2021-03-23
• Last updated: 2021-03-23