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

NCT04810754 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-03-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Daratumumab Injection

1800 mg per injection; 8 consecutive injections once a week; subcutaneous application in abdomen

Sponsors & Collaborators

  • Janssen-Cilag G.m.b.H

    collaborator INDUSTRY

  • Labor Berlin-Charité Vivantes G.m.b.H

    collaborator UNKNOWN

  • German Cancer Research Center

    collaborator OTHER

  • Charité Clinical Trial Office (CTO)

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Tobias Alexander, MD · Charite University, Berlin, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-03-31
Completion
2023-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810754 on ClinicalTrials.gov