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

Sponsor
Charite University, Berlin, Germany
Study ID
NCT04810754
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab Injection — DRUG
    1800 mg per injection; 8 consecutive injections once a week; subcutaneous application in abdomen

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Mar 2021
Primary completion
Mar 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab subcutaneous
    open label daratumumab s.c., unblinded

Primary Outcome Measure

Change in serum anti-dsDNA antibody titers [ Time Frame: Week 12 (i.e. 4 weeks after last daratumumab injection) ]

Central Contacts

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